Back to resultsTreatment Protocol for Children and Adolescents With Acute Lymphoblastic Leukemia - AIEOP-BFM ALL 2017
Primary Purpose
Acute Lymphoblastic Leukemia, Pediatric
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Blinatumomab
Bortezomib
Cyclophosphamide
Cytarabine
Daunorubicin
Myocet
Dexamethasone
Doxorubicin
Etoposide
Fludarabine Phosphate
Ifosfamide
6-Mercaptopurine
Methotrexate
Pegaspargase
Prednisolone
Tioguanin
Vincristine
Vindesine
Erwinase
Sponsored by
About this trial
This is an interventional treatment trial for Acute Lymphoblastic Leukemia, Pediatric focused on measuring Acute Lymphoblastic Leukemia, Childhood, Pediatric, Immunotherapy, Blinatumomab, Proteasome Inhibitor, Bispecific antibody, Bortezomib, Chemotherapy, Randomized trial
Eligibility Criteria
Inclusion Criteria:
- newly diagnosed acute lymphoblastic leukemia or
- newly diagnosed mixed phenotype acute leukemia (MPAL) meeting one of the following criteria:
- biphenotypic with a dominant T or B lineage assignment
- bilineal either with a dominant lymphoblastic population or if another reasonable rationale exists to treat the patient with an ALL-based therapy regimen
- newly diagnosed acute undifferentiated leukemia
- age < 18 years (up to 17 years and 365 days) at the day of diagnosis
- patient enrolled in a participating center
- written informed consent to trial participation and transfer and processing of data A subsequent removal from the study is only allowed if the inclusion criteria turn out not to be fulfilled or in the case of pregnancy of the patient.
Exclusion Criteria:
- Ph+ (BCR-ABL1 or t(9;22)-positive) ALL
- bilineal leukemia with a lymphoblastic and a separate non-lymphoblastic (≥ 10% of total cells) blast subset
- pre-treatment with cytostatic drugs
- glucocorticoid pre-treatment with ≥ 1 mg/kg/d for more than two weeks during the last month before diagnosis
- treatment started according to another protocol
- underlying disease that does not allow treatment according to the protocol (e.g. severe congenital heart disease, Charcot-Marie Syndrome, Ataxia-teleangiectasia…)
- ALL diagnosed as second malignancy and preceding chemotherapy and/or radiotherapy
- evidence of pregnancy or lactation period
- Sexually active adolescents not willing to use highly effective contraceptive method (pearl index <1) until 12 months after end of anti-leukemic therapy
- participation in another clinical trial except for add-on trials within the scope of supportive care approved by the sponsor
- live vaccine immunization within 2 weeks before start of protocol treatment
Sites / Locations
- Sydney Children's HospitalRecruiting
- The Children's Hospital at WestmeadRecruiting
- Univ.Klinik für Kinder- und Jugendheilkunde GrazRecruiting
- Univ.Klinik für Kinder- und Jugendheilkunde InnsbruckRecruiting
- Kepler UniversitätsklinikumRecruiting
- LKH SalzburgRecruiting
- St. Anna KinderspitalRecruiting
- University Hospital BrnoRecruiting
- University Hospital Hradec KrálovéRecruiting
- University Hospital OlomoucRecruiting
- University Hospital Ostrava-PorubaRecruiting
- University Hospital PlzeňRecruiting
- University Hospital MotolRecruiting
- Masaryk´s Hospital Ústí nad LabemRecruiting
- Regional Hospital České BudějoviceRecruiting
- Kinderklinik der med. Fakultät der RWTH, Bereich Hämatologie/OnkologieRecruiting
- I. Klinik für Kinder u. Jugendliche, Klinikum Augsburg, Hämatologie/ OnkologieRecruiting
- Klinikum Berlin-Buch II. Kinderklinik, Bereich Onkologie/Allg. PädiatrieRecruiting
- Kinderklinik der Charité, Campus Virchow Klinikum (CVK), Abt.: KinderhämatologieRecruiting
- Städtisches Krankenhaus, KinderklinikRecruiting
- Klinikum Chemnitz gGmbH, Klinik für Kinder- und Jugendmedizin, Hämatologie / OnkologieRecruiting
- Carl-Thiem-Klinikum, Kinderklinik, Abt. Hämatologie/OnkologieRecruiting
- Vestische Kinder- u. Jugendklinik, Universitätsklinik Witten/HerdeckeRecruiting
- Klinikum Dortmund, Klinik f. Kinder- und JugendmedizinRecruiting
- Universitatsklinikum Carl Gustav CarusRecruiting
- UniversitätsklinikRecruiting
- Helios Klinikum Erfurt GmbH, Klinik für KinderheilkundeRecruiting
- Universitaets - KinderklinikRecruiting
- Universitaetsklinikum EssenRecruiting
- Klinikum der J.W. Goethe UniversitaetRecruiting
- Universitaetskinderklinik - Universitaetsklinikum FreiburgRecruiting
- Klinikum der Justus-Liebig-Universität, Zentrum für Kinderheilkunde, Abt. Hämatologie/OnkologieRecruiting
- Klinik und Poliklinik für Kinder und Jugendmedizin, Allgemeine Pädiatrie mit Poliklinik/Pädiatrische Onkologie und HämatologieRecruiting
- Universitäts-Kinderklinik Päd. I, Hämatologie/OnkologieRecruiting
- Medizinische Hochschule Hannover, Zentrum Kinderheilkunde u. JugendmedizinRecruiting
- Universitäts-Kinderklinik, Päd. Onkologie, Hämatologie, und ImmunologieRecruiting
- Klinikum Heilbronn GmbH, Klinik für Kinderheilkunde und Jugendmedizin/PerinatalzentrumRecruiting
- Gemeinschaftskrankenhaus Herdecke, KinderabteilungRecruiting
- Universitaetsklinikum des SaarlandesRecruiting
- Klinikum, der Friedrich-Schiller-Universität, Klinik für Kinder- und JugendmedizinRecruiting
- Staedtisches Klinikum Karlsruhe gGmbHRecruiting
- Klinikum KasselRecruiting
- Klinik für Allgemeine Paediatrie, Univ.-Klinikum Schleswig-Holstein, Campus KielRecruiting
- Kliniken der Stadt Köln GmbH, Kinderkrankenhaus RiehlRecruiting
- Med. Einrichtungen der Universität zu Köln, Klinik für Allg. Kinderheilkunde, Onkologisch-hämatologische StationRecruiting
- Department für Frauen- und Kindermedizin, Abteilung für Pädiatrische Onkologie, Hämatologie und HämostaseologieRecruiting
- Universität zu Lübeck, Klinik für Kinder- u. Jugendmedizin, Abt. Hämatologie/ Onkologie/ImmunologieRecruiting
- Universitätsklinikum Magdeburg, Klinik für Päd. Hämatologie/OnkologieRecruiting
- Klinikum Mannheim gGmbH, Kinderklinik, Abt. Hämatologie/OnkologieRecruiting
- UniversitätsklinikumRecruiting
- Johannes Wesling Klinikum MindenRecruiting
- Städt. Krankenhaus München GmbH, Krankenhaus München-Schwabingen, Kinderklinik d. TURecruiting
- Ludwig-Maximilian-Universität, Dr. von Haunersches KinderspitalRecruiting
- Universitäts-Kinderklinik, Päd. Hämatologie und OnkologieRecruiting
- Cnopf'sche Kinderklinik, OnkologieRecruiting
- Klinikum Oldenburg gGmbH, Zentrum für Kinder- u. Jugendmedizin, (Elisabeth Kinderkrankenhaus)Recruiting
- UniversitätsklinikumRecruiting
- Universitäts-KinderklinikRecruiting
- Asklepios-Klinik, Sankt Augustin GmbHRecruiting
- HELIOS Kliniken Schwerin, Klinik f. Kinder-u. JugendmedizinRecruiting
- Olga-Hospital, Kinderklinik, Pädiatrisches Zentrum, Abt. Hämatologie/OnkologieRecruiting
- Krankenanstalt Trier, Mutterhaus der Borromaeerinnen, Pädiatrische AbteilungRecruiting
- Universitaetsklinikum TuebingenRecruiting
- Comprehensive Cancer Center Ulm at Universitaetsklinikum UlmRecruiting
- Stadtkrankenhaus, KinderklinikRecruiting
- Universitaets - Kinderklinik WuerzburgRecruiting
- Soroka University Medical CenterRecruiting
- Rambam Health Care CampusRecruiting
- Hadassah Medical centerRecruiting
- Schneider Children Medical Center of IsraelRecruiting
- Sheba Medical Center Tel-HashomerRecruiting
- Dana children hospitalRecruiting
- Azienda ospedali riunitiRecruiting
- AOUC Policlinico BariRecruiting
- A.O. Papa Giovanni XXIIIRecruiting
- Università di BolognaRecruiting
- ASST Spedali Civili di BresciaRecruiting
- Ospedale BusincoRecruiting
- Azienda ospedaliero universitariaRecruiting
- AO Pugliese CiaccioRecruiting
- S.O. Annunziata - A. O. CosenzaRecruiting
- Ospedale MeyerRecruiting
- Istituto Giannina GasliniRecruiting
- Policlinico di Modena Azienda Ospedaliero-UniversitariaRecruiting
- Clinica pediatrica Fondazione MBBMRecruiting
- A.O.U. VanvitelliRecruiting
- AORN Santobono PausiliponRecruiting
- Azienda ospedaliera di PadovaRecruiting
- Ospedale Civico ARNAS Civico e Di CristinaRecruiting
- Azienda ospedaliero-universitaria di ParmaRecruiting
- Fondazione IRCCS Policlinico San MatteoRecruiting
- Ospedale S. Maria della misericordiaRecruiting
- Ospedale Civile di PescaraRecruiting
- Ospedale Santa Chiara PisaRecruiting
- Grande ospedale metropolitano B-M-MRecruiting
- Ospedale infermiRecruiting
- Fondazione Policlinico GemelliRecruiting
- Ospedale Bambino GesùRecruiting
- Policlinico Umberto I Università Sapienza di RomaRecruiting
- Ospedale "Casa sollievo della sofferenza"Recruiting
- A.O.U. Città della salute e della scienza di TorinoRecruiting
- IRCCS Burlo GarofoloRecruiting
- AOU VeronaRecruiting
- Klinika pediatrickej hematológie a onkológie SZU a DFNsPRecruiting
- Comenius University Children's HospitalRecruiting
- Detská fakultná nemocnica KošiceRecruiting
- Kantonsspital AarauRecruiting
- Universitäts-Kinderspital beider BaselRecruiting
- Ospedale San Giovanni BellinzonaRecruiting
- Inselspital BernRecruiting
- HUG Hôpitaux Universitaires de GèneveRecruiting
- CHUV Centre Hospitalier Universitaire VaudoisRecruiting
- Luzerner Kantonsspital-Kinderspital LuzernRecruiting
- Ostschweizer KinderspitalRecruiting
- Universitäts-Kinderspital ZürichRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm 12
Arm Type
Active Comparator
Experimental
Experimental
Experimental
Active Comparator
Experimental
Experimental
Experimental
Other
Active Comparator
Experimental
Other
Arm Label
pB: early (non-)HR-standard/MR-standard
pB: early HR-exp./MR-standard
pB: early (non)HR-standard/MR-exp.
pB: early HR-exp./MR-exp.
pB: early (non-)HR-standard/HR-standard
pB: early HR-exp./HR-standard
pB: early (non-)HR-standard/HR-exp.
pB: early HR-exp./HR-exp.
pB: early non-HR/SR
T: early non-SR-standard/(non-)HR
T: early non-SR-exp/(non-)HR
T: early SR/non-HR
Arm Description
Induction (5 wks): "Protocol IA" with prednisolone, vincristine, daunorubicin, pegaspargase, IT methotrexate (MTX) Consolidation (6 w/4 w): "Consolidation extended" (control arm of randomization R-eHR) with cyclophosphamide, cytarabine, 6-mercaptopurine (6-MP), IT MTX, dexamethasone, vincristine, pegaspargase or "Consolidation short" (standard arm of early non-HR group) with cyclophosphamide, cytarabine, 6-mercaptopurine, IT MTX Extra-compartment phase (8 wks): "Protocol M" with 6-MP, HD-MTX, IT MTX Reinduction (6 wks): "Protocol II" with dexamethasone, vincristine, doxorubicin, pegaspargase, IT MTX, cyclophosphamide, tioguanine, cytarabine Maintenance (until 2 years after initial diagnosis): 6-MP, MTX [without preceding blinatumomab (control arm of randomization R-MR)] Erwinase is given in case of allergy to pegaspargase.
Induction (5 w): "Protocol IA" with prednisolone, vincristine, daunorubicin, pegaspargase, IT MTX Consolidation (6 w): "Consolidation extended+BZM" (experimental arm of randomization R-eHR) with cyclophosphamide, cytarabine, 6-MP, IT MTX, dexamethasone, vincristine, pegaspargase, bortezomib (given at 1.3 mg/m²/dose on days 50, 53, 56 and 59) Extra-compartment phase (8 wks): "Protocol M" with 6-MP, HD-MTX, IT MTX Reinduction (6 wks): "Protocol II" with dexamethasone, vincristine, doxorubicin, pegaspargase, IT MTX, cyclophosphamide, tioguanine, cytarabine Maintenance (until 2 yrs after initial diagnosis): 6-MP, MTX [without preceding blinatumomab (control arm of randomization R-MR)] Erwinase is given in case of allergy to pegaspargase.
Induction (5 w): "Protocol IA" with prednisolone, vincristine, daunorubicin, pegaspargase, IT MTX Consolidation (6 w/4 w): "Consolidation extended" (control arm in randomization R-eHR) with cyclophosphamide, cytarabine, 6-MP, IT MTX, dexamethasone, vincristine, pegaspargase or "Consolidation short" (standard arm of early non-HR group) with cyclophosphamide, cytarabine, 6-mercaptopurine, IT MTX Extra-compartment phase (8 w): "Protocol M" with 6-MP, HD-MTX, IT MTX Reinduction (6 w): "Protocol II" with dexamethasone, vincristine, doxorubicin, pegaspargase, IT MTX, cyclophosphamide, tioguanine, cytarabine Blinatumomab (4 w): 1 cycle blinatumomab given at 15 µg/m²/day for 28 days (experimental arm of randomization R-MR) Maintenance (until 2 yrs after initial diagnosis): 6-MP, MTX Erwinase is given in case of allergy to pegaspargase.
Induction (5 w): "Protocol IA" with prednisolone, vincristine, daunorubicin, pegaspargase, IT MTX Consolidation (6 w): "Consolidation extended+BZM" (experimental arm of randomization R-eHR) with cyclophosphamide, cytarabine, 6-MP, IT MTX, dexamethasone, vincristine, pegaspargase, bortezomib (given at 1.3 mg/m²/dose on days 50, 53, 56 and 59) Extra-compartment phase (8 w): "Protocol M" with 6-MP, HD-MTX,IT MTX Reinduction (6 weeks): "Protocol II" with dexamethasone, vincristine, doxorubicin, PEG-L-asparaginase, IT MTX, cyclophosphamide, tioguanine, cytarabine Blinatumomab (4 w): 1 cycle blinatumomab given at 15 µg/m²/day for 28 days (experimental arm of randomization R-MR) Maintenance phase (until 2 yrs after initial diagnosis): 6-MP, MTX Erwinase is given in case of allergy to pegaspargase.
Induction (5 w): as in other pB arms Consolidation (6 w/4 w): "Consolidation extended" (control arm in randomization R-eHR) with cyclophosphamide, cytarabine, 6-MP, IT methotrexate, dexamethasone, vincristine, pegaspargase or "Consolidation short" (standard arm of early non-HR group) with cyclophosphamide, cytarabine, 6-MP, IT MTX Intensified consolidation (3x5 d): Block HR-1' followed by HR-2' and HR-3' (control arm in randomization R-HR) with dexamethasone, vincristine, vindesine, daunorubicin, HD-MTX, IT MTX, HD-cytarabine, cyclophosphamide, ifosfamide, pegaspargase, etoposide Reinduction (3x4 w): "Protocol III" given 3 times with dexamethasone, vincristine, doxorubicin, pegaspargase, IT MTX, cyclophosphamide, tioguanine, cytarabine Maintenance (until 2 yrs after init. diagnosis): 6-MP, MTX Erwinase is given in case pegaspargase allergy. Pts with poor response to intensified consolidation receive Myocet-FLA (Myocet, fludarabine, HD-cytarabine, IT-MTX).
Induction (5 w): as in other pB arms Consolidation (6 w): "Consolidation extended+BZM" (experimental arm of randomization R-eHR) with cyclophosphamide, cytarabine, 6-MP, IT MTX, dexamethasone, vincristine, pegaspargase, bortezomib (1.3 mg/m²/dose on days 50, 53, 56 and 59) Intensified consolidation (3x5 d): Block HR-1' followed by HR-2' and HR-3' (control arm in randomization R-HR) with dexamethasone, vincristine, vindesine, daunorubicin, HD-MTX, IT MTX, HD-cytarabine, cyclophosphamide, ifosfamide, pegaspargase, etoposide Reinduction (3x4 w): as in arm "pB: early (non-)HR-standard/HR-standard" Maintenance (until 2 yrs after initial diagnosis): 6-MP, MTX Erwinase is given in case of allergy to pegaspargase. Pts with poor response to intensified consolidation receive Myocet-FLA (Myocet, fludarabine, HD-cytarabine, IT-MTX)
Induction (5 w): as in other pB arms Consolidation (6 w/4 w): "Consolidation extended" (control arm in randomization R-eHR) with cyclophosphamide, cytarabine, 6-MP, IT MTX, dexamethasone, vincristine, pegaspargase or "Consolidation short" (standard arm of early non-HR group) with cyclophosphamide, cytarabine, 6-MP, IT MTX Intensified consolidation (1x5 d + 2x28 d): Block HR-1' with dexamethasone, vincristine, HD-MTX, IT MTX, HD-cytarabine, cyclophosphamide, pegaspargase followed by 2 cycles blinatumomab at 15 µg/m²/day for 28 days per cycle plus 2x2 doses IT MTX (experimental arm of randomization R-HR) Reinduction (3x4 weeks): as in arm "pB: early (non-)HR-standard/HR-standard" Maintenance (until 2 yrs after init. diagnosis): 6-MP, MTX Erwinase is given in case of pegaspargase allergy. Pts with poor response to intensified consolidation receive Myocet-FLA (Myocet, fludarabine, HD-cytarabine, IT-MTX)
Induction (5 w): as in other pB arms Consolidation (6 w): "Consolidation extended+BZM" (experimental arm of randomization R-eHR) with cyclophosphamide, cytarabine, 6-MP, IT MTX, dexamethasone, vincristine, pegaspargase, bortezomib (1.3 mg/m²/dose on days 50, 53, 56 and 59) Intensified consolidation (1x5 d + 2x28 d): Block HR-1' with dexamethasone, vincristine, HD-MTX, IT MTX, HD-cytarabine, cyclophosphamide, pegaspargase followed by 2 cycles blinatumomab at 15 µg/m²/day for 28 days per cycle plus 2x2 doses IT MTX (experimental arm of randomization R-HR) Reinduction (3x4 weeks): as in arm "pB: early (non-)HR-standard/HR-standard" Maintenance (until 2 yrs after initial diagnosis): 6-MP, MTX Erwinase is given in case of allergy to pegaspargase. Pts with poor response to intensified consolidation receive Myocet-FLA (Myocet, fludarabine, HD-cytarabine, IT-MTX)
Induction (5 w): "Protocol IA" with prednisolone, vincristine, daunorubicin, pegaspargase, IT MTX Consolidation (4 w): "Consolidation short" with cyclophosphamide, cytarabine, 6-mercaptopurine, IT MTX Extra-compartment phase (8 w): "Protocol M" with 6-MP, HD-MTX, IT MTX Reinduction (6 w): "Protocol II" with dexamethasone, vincristine, doxorubicin, pegaspargase, IT MTX, cyclophosphamide, tioguanine, cytarabine Maintenance (until 2 yrs after initial diagnosis): 6-MP, MTX Erwinase is given in case of allergy to pegaspargase.
Induction (5 w): "Protocol IA-Dexa" with prednisolone/dexamethasone, vincristine, daunorubicin, pegaspargase, IT MTX or "Protocol IA-CPM" with prednisolone instead of dexamethasone and additional CPM Consolidation (4 w): "Protocol IB regular" (control arm in randomization. R-T) with cyclophosphamide, cytarabine, 6-mercaptopurine, IT MTX non-HR extra-compartment phase and reinduction: as in arm "pB: early non-HR/SR" HR intensified consolidation and reinduction: as in arm "pB: early (non-)HR-standard/HR-standard" Maintenance (until 2 yrs after initial diagnosis): 6-MP, MTX Erwinase is given in case of allergy to pegaspargase. Pts with poor response to intensified consolidation receive Myocet-FLA (Myocet, fludarabine, HD-cytarabine, IT-MTX)
Induction (5 w): "Protocol IA-Dexa" with prednisolone/dexamethasone, vincristine, daunorubicin, pegaspargase, IT MTX or "Protocol IA-CPM" with prednisolone instead of dexamethasone and additional CPM Consolidation (6 w): "Protocol IB long" (experimental arm in randomization R-T) with cyclophosphamide, cytarabine, 6-mercaptopurine, IT MTX non-HR extra-compartment phase and reinduction: as in arm "pB: early non-HR/SR" HR intensified consolidation and reinduction: as in arm "pB: early (non-)HR-standard/HR-standard" Maintenance (until 2 yrs after initial diagnosis): 6-MP, MTX Erwinase is given in case of allergy to pegaspargase. Pts with poor response to intensified consolidation receive Myocet-FLA (Myocet, fludarabine, HD-cytarabine, IT-MTX)
Induction (5 w): "Protocol IA-Dexa" with prednisolone/dexamethasone, vincristine, daunorubicin, pegaspargase, IT MTX Consolidation (4 w): "Protocol IB regular" with cyclophosphamide, cytarabine, 6-mercaptopurine, IT MTX Extra-compartment phase (8 w): "Protocol M" with 6-MP, HD-MTX, IT MTX Reinduction (6 w): "Protocol II" with dexamethasone, vincristine, doxorubicin, pegaspargase, IT MTX, cyclophosphamide, tioguanine, cytarabine Maintenance (until 2 yrs after initial diagnosis): 6-MP, MTX Erwinase is given in case of allergy to pegaspargase.
Outcomes
Primary Outcome Measures
Event-free survival
Randomization R-eHR, R-HR and R-T: Time from randomization until the first event defined as follow: cytomorphological or molecular non-response (resistance to protocol treatment, considered as event at day zero), relapse, second malignancy or death from any cause. This will be called EFS time.
Disease-free survival
Randomization R-MR: Time from randomization until the first event defined as follow: Relapse, second malignancy or death from any cause. This will be called DFS time.
Secondary Outcome Measures
Survival
All patients/randomizations: Time until death from any cause, starting at the same time point as the EFS/DFS.
Treatment-related mortality
Frequency and incidence of treatment-related mortality in induction or continuous complete remission
Adverse Events of interest/Serious Adverse Events
Frequency and incidence of adverse events of interest and serious adverse events in specific protocol phases, randomized arms and overall during follow-up
MRD response
MRD load after the randomized treatment phases (R-eHR, R-HR, R-MR and R-T) as well as after the first/second cycle of Blinatumomab or after the HR 2'/HR 3' block (R-HR)
Proportion of patients with Blina Poor-Response
Proportion of patients with poor MRD response to the first Blinatumomab cycle ("Blinatumomab Poor-Response") (R-HR)
Full Information
NCT ID
NCT03643276
First Posted
July 12, 2018
Last Updated
November 1, 2022
Sponsor
Martin Schrappe
Collaborators
Deutsche Krebshilfe e.V., Bonn (Germany)
1. Study Identification
Unique Protocol Identification Number
NCT03643276
Brief Title
Treatment Protocol for Children and Adolescents With Acute Lymphoblastic Leukemia - AIEOP-BFM ALL 2017
Official Title
International Collaborative Treatment Protocol for Children and Adolescents With Acute Lymphoblastic Leukemia - AIEOP-BFM ALL 2017
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2018 (Actual)
Primary Completion Date
July 14, 2028 (Anticipated)
Study Completion Date
July 14, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Martin Schrappe
Collaborators
Deutsche Krebshilfe e.V., Bonn (Germany)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The understanding of acute lymphoblastic leukemia (ALL) in childhood and adolescence has largely changed due to extensive genetic research in recent years: ALL is now considered to be a very heterogeneous disease group. The leukemia cells present themselves with quite differently activated regulatory mechanisms of the malignant phenotype. The introduction of more accurate methods of assessing therapy response ("minimal residual disease [MRD] tests") has provided new insights into very different mechanisms of action, including factors influenced by host factors; this has had practical clinical consequences for the use of more individualized therapy. Multimodal therapies have enabled a cure level of over 80% for ALL in this age group. However, the own and international study data show that the therapy toxicity of the contemporary chemotherapy concepts has become unacceptably high, in particular with respect to those intensified therapies used for the treatment of patients at high risk of ALL relapse.
The AIEOP-BFM ALL 2017 study therefore aims for an innovative integrated approach that will not only adapt the risk stratification to new prognostic markers using more comprehensive diagnostics, but above all, qualitatively reorient the therapy. The most important consequence will be that this study is testing immunotherapy with the bispecific antibody blinatumomab as an alternative to particularly intensive and toxic chemotherapy elements in precursor B-cell ALL (pB-ALL) patients with detectable chemotherapy resistance and at high risk of relapse. With the aim to complement the effects of the conventional chemotherapy, Blinatumomab is in addition tested in the large group of pB-ALL patients at intermediate relapse risk with seemingly unremarkable leukemia, but who account for a large proportion of all relapses. Targeted therapy is also used in the form of the proteasome inhibitor bortezomib for patients with pB-ALL and slow response to the drugs of the induction chemotherapy with the aim to overcome intrinsic chemotherapy resistance of the ALL cells. In patients with T-lineage ALL, who have particularly poor chances for cure after relapse, the established consolidation chemotherapy has proved to be particularly effective. This chemotherapy phase is therefore tested in a longer and more intensive form in such T-ALL patients with intermediate or slow early treatment response with the aim to reduce the relapses rate in this subgroup.
Detailed Description
Patients are stratified into 4 early risk groups for therapy during the consolidation phase (T/early SR, T/early non-SR, pB/early non-HR, pB/early HR) and 5 risk groups for post-consolidation therapy (T/non-HR, T/HR, pB/SR, pB/MR, pB/HR). Risk stratification is based on immunophenotypic lineage, genetics of leukemic cells and treatment response on the basis of cytomorphology and methods for detection minimal residual disease.
The trial includes four randomized study questions testing experimental treatments on top of the risk-stratified standard chemotherapy backbone:
Primary study questions:
Randomization R-eHR: Early High-risk (early HR) pB-ALL defined by genetics and/or inadequate treatment response over the course of induction: Can the probability of event-free survival (pEFS) from time of randomization be improved by additional therapy with the proteasome inhibitor bortezomib during an extended consolidation treatment phase compared with standard extended consolidation?
Randomization R-HR: High-risk (HR) pB-ALL defined by genetics and/or inadequate treatment response by the end of consolidation: Can the pEFS from time of randomization be improved by a treatment concept including two cycles of post-consolidation immunotherapy with blinatumomab (15 µg/m²/d for 28 days per cycle) plus 4 doses intrathecal Methotrexate replacing two conventional highly intensive chemotherapy courses?
Randomization R-MR: Intermediate risk (MR) pB-ALL defined by genetics and intermediate MRD response: Can the probability of disease-free survival (pDFS) from time of randomization be improved by additional therapy with one cycle of post-reintensification immunotherapy with blinatumomab (15 µg/m²/d for 28 days)?
Randomization R-T: Early non-standard risk (early non-SR) T-ALL patients defined by treatment response over the course of induction: Can the pEFS from time of randomization be improved by the extension of the standard of care consolidation phase by 14 days with an increase of the consolidation cumulative doses of Cyclophosphamide, Cytarabine and 6-Mercaptopurine by 50%?
Secondary study questions:
All randomizations: Can the overall survival be improved by the treatment in the experimental arm?
All randomizations: What is the incidence of treatment-related toxicities and mortality in the experimental arm compared to the standard arm?
Randomization R-eHR: Can the MRD load after consolidation treatment be reduced by the additional treatment with bortezomib?
Randomization R-HR: Can treatment-related life-threatening complications and mortality during the intensified consolidation phase of high-risk treatment be reduced when replacing two intensive chemotherapy courses by two cycles of immunotherapy with blinatumomab?
Randomization R-HR: What is the proportion of patients with insufficient MRD response to blinatumomab as defined in the protocol as compared to the MRD response after the HR-2' block in the control arm?
Randomization R-HR: Can the MRD load after the first treatment cycle (HR 2'/blinatumomab) and the second cycle (HR-3'/blinatumomab) be reduced in the experimental arm when compared with conventional intensive chemotherapy? Randomization R-MR: What is the proportion of patients with positive MRD after reintensification Protocol II who become MRD-negative over the blinatumomab cycle compared to 4 weeks of standard maintenance therapy?
Randomization R-T: Can the MRD load after consolidation treatment be reduced by extension of the consolidation phase?
Standard-risk patients: Is the clinical outcome comparable to that obtained for standard-risk patients in study AIEOP-BFM ALL 2009?
A small subgroup of patients at very high relapse risk is eligible for allogeneic hematopoietic stem cell transplantation after the intensified consolidation therapy phase.
Patients with T-ALL and hyperleukocytosis (>=100,000/µL) and patients with CNS involvement at diagnosis (CNS3 status) are eligible for cranial irradiation with 12 Gy if age at time of irradiation is at least 4 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia, Pediatric
Keywords
Acute Lymphoblastic Leukemia, Childhood, Pediatric, Immunotherapy, Blinatumomab, Proteasome Inhibitor, Bispecific antibody, Bortezomib, Chemotherapy, Randomized trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Model Description
pB-ALL/MR: 2 parallel groups (R-MR) or 2x2 factorial design (R-eHR, R-MR) depending on early risk group assignment.
pB-ALL/HR: 2 parallel groups (R-HR) or 2x2 factorial design (R-eHR, R-HR) depending on early risk group assignment.
T-ALL/early non-SR: 2 parallel groups (R-T).
pB-ALL/SR: Single group.
T-ALL/early SR: Single group.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
pB: early (non-)HR-standard/MR-standard
Arm Type
Active Comparator
Arm Description
Induction (5 wks): "Protocol IA" with prednisolone, vincristine, daunorubicin, pegaspargase, IT methotrexate (MTX)
Consolidation (6 w/4 w): "Consolidation extended" (control arm of randomization R-eHR) with cyclophosphamide, cytarabine, 6-mercaptopurine (6-MP), IT MTX, dexamethasone, vincristine, pegaspargase or "Consolidation short" (standard arm of early non-HR group) with cyclophosphamide, cytarabine, 6-mercaptopurine, IT MTX
Extra-compartment phase (8 wks): "Protocol M" with 6-MP, HD-MTX, IT MTX
Reinduction (6 wks): "Protocol II" with dexamethasone, vincristine, doxorubicin, pegaspargase, IT MTX, cyclophosphamide, tioguanine, cytarabine
Maintenance (until 2 years after initial diagnosis): 6-MP, MTX [without preceding blinatumomab (control arm of randomization R-MR)]
Erwinase is given in case of allergy to pegaspargase.
Arm Title
pB: early HR-exp./MR-standard
Arm Type
Experimental
Arm Description
Induction (5 w): "Protocol IA" with prednisolone, vincristine, daunorubicin, pegaspargase, IT MTX
Consolidation (6 w): "Consolidation extended+BZM" (experimental arm of randomization R-eHR) with cyclophosphamide, cytarabine, 6-MP, IT MTX, dexamethasone, vincristine, pegaspargase, bortezomib (given at 1.3 mg/m²/dose on days 50, 53, 56 and 59)
Extra-compartment phase (8 wks): "Protocol M" with 6-MP, HD-MTX, IT MTX
Reinduction (6 wks): "Protocol II" with dexamethasone, vincristine, doxorubicin, pegaspargase, IT MTX, cyclophosphamide, tioguanine, cytarabine
Maintenance (until 2 yrs after initial diagnosis): 6-MP, MTX [without preceding blinatumomab (control arm of randomization R-MR)]
Erwinase is given in case of allergy to pegaspargase.
Arm Title
pB: early (non)HR-standard/MR-exp.
Arm Type
Experimental
Arm Description
Induction (5 w): "Protocol IA" with prednisolone, vincristine, daunorubicin, pegaspargase, IT MTX
Consolidation (6 w/4 w): "Consolidation extended" (control arm in randomization R-eHR) with cyclophosphamide, cytarabine, 6-MP, IT MTX, dexamethasone, vincristine, pegaspargase or "Consolidation short" (standard arm of early non-HR group) with cyclophosphamide, cytarabine, 6-mercaptopurine, IT MTX
Extra-compartment phase (8 w): "Protocol M" with 6-MP, HD-MTX, IT MTX
Reinduction (6 w): "Protocol II" with dexamethasone, vincristine, doxorubicin, pegaspargase, IT MTX, cyclophosphamide, tioguanine, cytarabine
Blinatumomab (4 w): 1 cycle blinatumomab given at 15 µg/m²/day for 28 days (experimental arm of randomization R-MR)
Maintenance (until 2 yrs after initial diagnosis): 6-MP, MTX
Erwinase is given in case of allergy to pegaspargase.
Arm Title
pB: early HR-exp./MR-exp.
Arm Type
Experimental
Arm Description
Induction (5 w): "Protocol IA" with prednisolone, vincristine, daunorubicin, pegaspargase, IT MTX
Consolidation (6 w): "Consolidation extended+BZM" (experimental arm of randomization R-eHR) with cyclophosphamide, cytarabine, 6-MP, IT MTX, dexamethasone, vincristine, pegaspargase, bortezomib (given at 1.3 mg/m²/dose on days 50, 53, 56 and 59)
Extra-compartment phase (8 w): "Protocol M" with 6-MP, HD-MTX,IT MTX
Reinduction (6 weeks): "Protocol II" with dexamethasone, vincristine, doxorubicin, PEG-L-asparaginase, IT MTX, cyclophosphamide, tioguanine, cytarabine
Blinatumomab (4 w): 1 cycle blinatumomab given at 15 µg/m²/day for 28 days (experimental arm of randomization R-MR)
Maintenance phase (until 2 yrs after initial diagnosis): 6-MP, MTX
Erwinase is given in case of allergy to pegaspargase.
Arm Title
pB: early (non-)HR-standard/HR-standard
Arm Type
Active Comparator
Arm Description
Induction (5 w): as in other pB arms
Consolidation (6 w/4 w): "Consolidation extended" (control arm in randomization R-eHR) with cyclophosphamide, cytarabine, 6-MP, IT methotrexate, dexamethasone, vincristine, pegaspargase or "Consolidation short" (standard arm of early non-HR group) with cyclophosphamide, cytarabine, 6-MP, IT MTX
Intensified consolidation (3x5 d): Block HR-1' followed by HR-2' and HR-3' (control arm in randomization R-HR) with dexamethasone, vincristine, vindesine, daunorubicin, HD-MTX, IT MTX, HD-cytarabine, cyclophosphamide, ifosfamide, pegaspargase, etoposide
Reinduction (3x4 w): "Protocol III" given 3 times with dexamethasone, vincristine, doxorubicin, pegaspargase, IT MTX, cyclophosphamide, tioguanine, cytarabine
Maintenance (until 2 yrs after init. diagnosis): 6-MP, MTX
Erwinase is given in case pegaspargase allergy. Pts with poor response to intensified consolidation receive Myocet-FLA (Myocet, fludarabine, HD-cytarabine, IT-MTX).
Arm Title
pB: early HR-exp./HR-standard
Arm Type
Experimental
Arm Description
Induction (5 w): as in other pB arms
Consolidation (6 w): "Consolidation extended+BZM" (experimental arm of randomization R-eHR) with cyclophosphamide, cytarabine, 6-MP, IT MTX, dexamethasone, vincristine, pegaspargase, bortezomib (1.3 mg/m²/dose on days 50, 53, 56 and 59)
Intensified consolidation (3x5 d): Block HR-1' followed by HR-2' and HR-3' (control arm in randomization R-HR) with dexamethasone, vincristine, vindesine, daunorubicin, HD-MTX, IT MTX, HD-cytarabine, cyclophosphamide, ifosfamide, pegaspargase, etoposide
Reinduction (3x4 w): as in arm "pB: early (non-)HR-standard/HR-standard"
Maintenance (until 2 yrs after initial diagnosis): 6-MP, MTX
Erwinase is given in case of allergy to pegaspargase. Pts with poor response to intensified consolidation receive Myocet-FLA (Myocet, fludarabine, HD-cytarabine, IT-MTX)
Arm Title
pB: early (non-)HR-standard/HR-exp.
Arm Type
Experimental
Arm Description
Induction (5 w): as in other pB arms
Consolidation (6 w/4 w): "Consolidation extended" (control arm in randomization R-eHR) with cyclophosphamide, cytarabine, 6-MP, IT MTX, dexamethasone, vincristine, pegaspargase or "Consolidation short" (standard arm of early non-HR group) with cyclophosphamide, cytarabine, 6-MP, IT MTX
Intensified consolidation (1x5 d + 2x28 d): Block HR-1' with dexamethasone, vincristine, HD-MTX, IT MTX, HD-cytarabine, cyclophosphamide, pegaspargase followed by 2 cycles blinatumomab at 15 µg/m²/day for 28 days per cycle plus 2x2 doses IT MTX (experimental arm of randomization R-HR)
Reinduction (3x4 weeks): as in arm "pB: early (non-)HR-standard/HR-standard"
Maintenance (until 2 yrs after init. diagnosis): 6-MP, MTX
Erwinase is given in case of pegaspargase allergy. Pts with poor response to intensified consolidation receive Myocet-FLA (Myocet, fludarabine, HD-cytarabine, IT-MTX)
Arm Title
pB: early HR-exp./HR-exp.
Arm Type
Experimental
Arm Description
Induction (5 w): as in other pB arms
Consolidation (6 w): "Consolidation extended+BZM" (experimental arm of randomization R-eHR) with cyclophosphamide, cytarabine, 6-MP, IT MTX, dexamethasone, vincristine, pegaspargase, bortezomib (1.3 mg/m²/dose on days 50, 53, 56 and 59)
Intensified consolidation (1x5 d + 2x28 d): Block HR-1' with dexamethasone, vincristine, HD-MTX, IT MTX, HD-cytarabine, cyclophosphamide, pegaspargase followed by 2 cycles blinatumomab at 15 µg/m²/day for 28 days per cycle plus 2x2 doses IT MTX (experimental arm of randomization R-HR)
Reinduction (3x4 weeks): as in arm "pB: early (non-)HR-standard/HR-standard" Maintenance (until 2 yrs after initial diagnosis): 6-MP, MTX
Erwinase is given in case of allergy to pegaspargase. Pts with poor response to intensified consolidation receive Myocet-FLA (Myocet, fludarabine, HD-cytarabine, IT-MTX)
Arm Title
pB: early non-HR/SR
Arm Type
Other
Arm Description
Induction (5 w): "Protocol IA" with prednisolone, vincristine, daunorubicin, pegaspargase, IT MTX
Consolidation (4 w): "Consolidation short" with cyclophosphamide, cytarabine, 6-mercaptopurine, IT MTX
Extra-compartment phase (8 w): "Protocol M" with 6-MP, HD-MTX, IT MTX
Reinduction (6 w): "Protocol II" with dexamethasone, vincristine, doxorubicin, pegaspargase, IT MTX, cyclophosphamide, tioguanine, cytarabine
Maintenance (until 2 yrs after initial diagnosis): 6-MP, MTX
Erwinase is given in case of allergy to pegaspargase.
Arm Title
T: early non-SR-standard/(non-)HR
Arm Type
Active Comparator
Arm Description
Induction (5 w): "Protocol IA-Dexa" with prednisolone/dexamethasone, vincristine, daunorubicin, pegaspargase, IT MTX or "Protocol IA-CPM" with prednisolone instead of dexamethasone and additional CPM
Consolidation (4 w): "Protocol IB regular" (control arm in randomization. R-T) with cyclophosphamide, cytarabine, 6-mercaptopurine, IT MTX
non-HR extra-compartment phase and reinduction: as in arm "pB: early non-HR/SR"
HR intensified consolidation and reinduction: as in arm "pB: early (non-)HR-standard/HR-standard"
Maintenance (until 2 yrs after initial diagnosis): 6-MP, MTX
Erwinase is given in case of allergy to pegaspargase. Pts with poor response to intensified consolidation receive Myocet-FLA (Myocet, fludarabine, HD-cytarabine, IT-MTX)
Arm Title
T: early non-SR-exp/(non-)HR
Arm Type
Experimental
Arm Description
Induction (5 w): "Protocol IA-Dexa" with prednisolone/dexamethasone, vincristine, daunorubicin, pegaspargase, IT MTX or "Protocol IA-CPM" with prednisolone instead of dexamethasone and additional CPM
Consolidation (6 w): "Protocol IB long" (experimental arm in randomization R-T) with cyclophosphamide, cytarabine, 6-mercaptopurine, IT MTX
non-HR extra-compartment phase and reinduction: as in arm "pB: early non-HR/SR"
HR intensified consolidation and reinduction: as in arm "pB: early (non-)HR-standard/HR-standard"
Maintenance (until 2 yrs after initial diagnosis): 6-MP, MTX
Erwinase is given in case of allergy to pegaspargase. Pts with poor response to intensified consolidation receive Myocet-FLA (Myocet, fludarabine, HD-cytarabine, IT-MTX)
Arm Title
T: early SR/non-HR
Arm Type
Other
Arm Description
Induction (5 w): "Protocol IA-Dexa" with prednisolone/dexamethasone, vincristine, daunorubicin, pegaspargase, IT MTX
Consolidation (4 w): "Protocol IB regular" with cyclophosphamide, cytarabine, 6-mercaptopurine, IT MTX
Extra-compartment phase (8 w): "Protocol M" with 6-MP, HD-MTX, IT MTX
Reinduction (6 w): "Protocol II" with dexamethasone, vincristine, doxorubicin, pegaspargase, IT MTX, cyclophosphamide, tioguanine, cytarabine
Maintenance (until 2 yrs after initial diagnosis): 6-MP, MTX
Erwinase is given in case of allergy to pegaspargase.
Intervention Type
Drug
Intervention Name(s)
Blinatumomab
Intervention Description
Experimental therapy in randomizations R-HR and R-MR
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Intervention Description
Experimental therapy in randomization R-eHR
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Part of standard chemotherapy and included in experimental treatment phase Protocol IB long in randomization R-T
Intervention Type
Drug
Intervention Name(s)
Cytarabine
Intervention Description
Part of standard chemotherapy and included in experimental treatment phase Protocol IB long in randomization R-T and in the intensification block Myocet-FLA for patients with very high relapse risk
Intervention Type
Drug
Intervention Name(s)
Daunorubicin
Intervention Description
Part of standard chemotherapy
Intervention Type
Drug
Intervention Name(s)
Myocet
Intervention Description
Part of intensification block Myocet-FLA for patients with very high relapse risk
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Part of standard chemotherapy
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Intervention Description
Part of standard chemotherapy
Intervention Type
Drug
Intervention Name(s)
Etoposide
Intervention Description
Part of standard chemotherapy
Intervention Type
Drug
Intervention Name(s)
Fludarabine Phosphate
Intervention Description
Part of intensification block Myocet-FLA for patients with very high relapse risk
Intervention Type
Drug
Intervention Name(s)
Ifosfamide
Intervention Description
Part of standard chemotherapy
Intervention Type
Drug
Intervention Name(s)
6-Mercaptopurine
Intervention Description
Part of standard chemotherapy and included in experimental treatment phase Protocol IB long in randomization R-T
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
Part of standard chemotherapy
Intervention Type
Drug
Intervention Name(s)
Pegaspargase
Intervention Description
Part of standard chemotherapy
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Other Intervention Name(s)
Prednisone
Intervention Description
Part of standard chemotherapy
Intervention Type
Drug
Intervention Name(s)
Tioguanin
Intervention Description
Part of standard chemotherapy
Intervention Type
Drug
Intervention Name(s)
Vincristine
Intervention Description
Part of standard chemotherapy
Intervention Type
Drug
Intervention Name(s)
Vindesine
Intervention Description
Part of standard chemotherapy
Intervention Type
Drug
Intervention Name(s)
Erwinase
Intervention Description
Part of standard chemotherapy as substitute for PEG-L-Asparaginase in case of allergic reaction
Primary Outcome Measure Information:
Title
Event-free survival
Description
Randomization R-eHR, R-HR and R-T: Time from randomization until the first event defined as follow: cytomorphological or molecular non-response (resistance to protocol treatment, considered as event at day zero), relapse, second malignancy or death from any cause. This will be called EFS time.
Time Frame
Assessed up to 120 months from start of study
Title
Disease-free survival
Description
Randomization R-MR: Time from randomization until the first event defined as follow: Relapse, second malignancy or death from any cause. This will be called DFS time.
Time Frame
Assessed up to 120 months from start of study
Secondary Outcome Measure Information:
Title
Survival
Description
All patients/randomizations: Time until death from any cause, starting at the same time point as the EFS/DFS.
Time Frame
Assessed up to 120 months from start of study
Title
Treatment-related mortality
Description
Frequency and incidence of treatment-related mortality in induction or continuous complete remission
Time Frame
Assessed up to 120 months from start of study
Title
Adverse Events of interest/Serious Adverse Events
Description
Frequency and incidence of adverse events of interest and serious adverse events in specific protocol phases, randomized arms and overall during follow-up
Time Frame
Assessed up to 120 months from start of study
Title
MRD response
Description
MRD load after the randomized treatment phases (R-eHR, R-HR, R-MR and R-T) as well as after the first/second cycle of Blinatumomab or after the HR 2'/HR 3' block (R-HR)
Time Frame
Measurements of MRD response at end of randomized treatments (intended time frame 13 weeks in R-eHR/R-T, 26 weeks in R-HR, 34 weeks in R-MR).
Title
Proportion of patients with Blina Poor-Response
Description
Proportion of patients with poor MRD response to the first Blinatumomab cycle ("Blinatumomab Poor-Response") (R-HR)
Time Frame
Measurements of MRD response intended after 30 weeks from individual start of treatment, assessment of proportion at 120 months from start of study
10. Eligibility
Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
newly diagnosed acute lymphoblastic leukemia or
newly diagnosed mixed phenotype acute leukemia (MPAL) meeting one of the following criteria:
biphenotypic with a dominant T or B lineage assignment
bilineal either with a dominant lymphoblastic population or if another reasonable rationale exists to treat the patient with an ALL-based therapy regimen
newly diagnosed acute undifferentiated leukemia
age < 18 years (up to 17 years and 365 days) at the day of diagnosis
patient enrolled in a participating center
written informed consent to trial participation and transfer and processing of data A subsequent removal from the study is only allowed if the inclusion criteria turn out not to be fulfilled or in the case of pregnancy of the patient.
Exclusion Criteria:
Ph+ (BCR-ABL1 or t(9;22)-positive) ALL
bilineal leukemia with a lymphoblastic and a separate non-lymphoblastic (≥ 10% of total cells) blast subset
pre-treatment with cytostatic drugs
glucocorticoid pre-treatment with ≥ 1 mg/kg/d for more than two weeks during the last month before diagnosis
treatment started according to another protocol
underlying disease that does not allow treatment according to the protocol (e.g. severe congenital heart disease, Charcot-Marie Syndrome, Ataxia-teleangiectasia…)
ALL diagnosed as second malignancy and preceding chemotherapy and/or radiotherapy
evidence of pregnancy or lactation period
Sexually active adolescents not willing to use highly effective contraceptive method (pearl index <1) until 12 months after end of anti-leukemic therapy
participation in another clinical trial except for add-on trials within the scope of supportive care approved by the sponsor
live vaccine immunization within 2 weeks before start of protocol treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anja Möricke, MD
Phone
+4943150020150
Email
a.moericke@pediatrics.uni-kiel.de
First Name & Middle Initial & Last Name or Official Title & Degree
Lile Bauer
Phone
+4943150020152
Email
lile.bauer@uksh.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Schrappe, MD
Organizational Affiliation
Department of Pediatrics, University Hospital of Schleswig-Holstein, Campus Kiel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sydney Children's Hospital
City
Sydney
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Draga Barbaric
Facility Name
The Children's Hospital at Westmead
City
Westmead
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luciano Dalla-Pozza
Facility Name
Univ.Klinik für Kinder- und Jugendheilkunde Graz
City
Graz
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Benesch
Facility Name
Univ.Klinik für Kinder- und Jugendheilkunde Innsbruck
City
Innsbruck
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernhard Meister
Facility Name
Kepler Universitätsklinikum
City
Linz
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georg Ebetsberger
Facility Name
LKH Salzburg
City
Salzburg
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neil Jones
Facility Name
St. Anna Kinderspital
City
Vienna
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andishe Attarbaschi
Facility Name
University Hospital Brno
City
Brno
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaroslav Štěrba
Facility Name
University Hospital Hradec Králové
City
Hradec Králové
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiří Hak
Facility Name
University Hospital Olomouc
City
Olomouc
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dagmar Pospíšilová
Facility Name
University Hospital Ostrava-Poruba
City
Ostrava-Poruba
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tomáš Kuhn
Facility Name
University Hospital Plzeň
City
Plzeň
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tomáš Votava
Facility Name
University Hospital Motol
City
Praha
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Starý
Facility Name
Masaryk´s Hospital Ústí nad Labem
City
Ústí nad Labem
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniela Procházková
Facility Name
Regional Hospital České Budějovice
City
České Budějovice
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pavel Timr
Facility Name
Kinderklinik der med. Fakultät der RWTH, Bereich Hämatologie/Onkologie
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Udo Kontny
Phone
+49 241808
Ext
9902
Email
ukontny@ukaachen.de
Facility Name
I. Klinik für Kinder u. Jugendliche, Klinikum Augsburg, Hämatologie/ Onkologie
City
Augsburg
ZIP/Postal Code
86156
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Frühwald
Phone
+49 821400
Ext
3631
Facility Name
Klinikum Berlin-Buch II. Kinderklinik, Bereich Onkologie/Allg. Pädiatrie
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lothar Schweigerer
Phone
+49 309401
Ext
2367
Email
lschweigerer@berlin.helio-kliniken.de
Facility Name
Kinderklinik der Charité, Campus Virchow Klinikum (CVK), Abt.: Kinderhämatologie
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arend Stackelberg
Phone
+49 30450566
Ext
833
Email
arend.stackelberg@charite.de
Facility Name
Städtisches Krankenhaus, Kinderklinik
City
Braunschweig
ZIP/Postal Code
38118
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wolfgang Eberl
Phone
+49 531595
Ext
1424
Email
w.eberl@klinkum-braunschweig.de
Facility Name
Klinikum Chemnitz gGmbH, Klinik für Kinder- und Jugendmedizin, Hämatologie / Onkologie
City
Chemnitz
ZIP/Postal Code
09009
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andre Hofmann
Phone
+49 3713332
Ext
4287
Email
a.hofmann@skc.de
Facility Name
Carl-Thiem-Klinikum, Kinderklinik, Abt. Hämatologie/Onkologie
City
Cottbus
ZIP/Postal Code
03048
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georg Schwabe
Phone
+49 35546
Ext
2332
Facility Name
Vestische Kinder- u. Jugendklinik, Universitätsklinik Witten/Herdecke
City
Datteln
ZIP/Postal Code
45711
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Wiesel
Phone
+49 236397
Ext
5846
Email
th.wiesel@kinderklinik-datteln.de
Facility Name
Klinikum Dortmund, Klinik f. Kinder- und Jugendmedizin
City
Dortmund
ZIP/Postal Code
44137
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominik Schneider
Phone
+49 2319532
Ext
1050
Email
dominik.schneider@klinikumdo.de
Facility Name
Universitatsklinikum Carl Gustav Carus
City
Dresden
ZIP/Postal Code
D-01307
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
R. Knöfler, MD
Facility Name
Universitätsklinik
City
Düsseldorf
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arndt Borkhardt, Prof.
Facility Name
Helios Klinikum Erfurt GmbH, Klinik für Kinderheilkunde
City
Erfurt
ZIP/Postal Code
99089
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Axel Sauerbrey
Phone
+49 36178
Ext
4501
Email
axel.sauerbrey@helios-kliniken.de
Facility Name
Universitaets - Kinderklinik
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
M. Metzler, MD
Facility Name
Universitaetsklinikum Essen
City
Essen
ZIP/Postal Code
D-45147
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rita Beier, MD
Facility Name
Klinikum der J.W. Goethe Universitaet
City
Frankfurt
ZIP/Postal Code
D-60590
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Klingebiel, MD
Phone
49-69-6301-5094
Email
thomas.klingebiel@kgu.de
Facility Name
Universitaetskinderklinik - Universitaetsklinikum Freiburg
City
Freiburg
ZIP/Postal Code
D-79106
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlotte Niemeyer, MD
Phone
49-761-270-4506
Email
charlotte.niemeyer@uniklinik-freiburg.de
Facility Name
Klinikum der Justus-Liebig-Universität, Zentrum für Kinderheilkunde, Abt. Hämatologie/Onkologie
City
Gießen
ZIP/Postal Code
35385
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Mauz-Körholz
Facility Name
Klinik und Poliklinik für Kinder und Jugendmedizin, Allgemeine Pädiatrie mit Poliklinik/Pädiatrische Onkologie und Hämatologie
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Holger Lode
Phone
+49 383486
Ext
6325
Email
holger.lode@uni-greifswald.de
Facility Name
Universitäts-Kinderklinik Päd. I, Hämatologie/Onkologie
City
Göttingen
ZIP/Postal Code
37099
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ingrid Kühnle
Phone
+49 55139
Ext
6201
Facility Name
Medizinische Hochschule Hannover, Zentrum Kinderheilkunde u. Jugendmedizin
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christin Linderkamp
Phone
+49 511532
Ext
6710
Email
linderkamp.christin@mh-hannover.de
Facility Name
Universitäts-Kinderklinik, Päd. Onkologie, Hämatologie, und Immunologie
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wolfgang Behnisch
Phone
+49 622156
Ext
4555
Email
wolfgang.behnisch@med.uni-heidelberg.de
Facility Name
Klinikum Heilbronn GmbH, Klinik für Kinderheilkunde und Jugendmedizin/Perinatalzentrum
City
Heilbronn
ZIP/Postal Code
74078
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hermann Full
Phone
+49 713149
Ext
3702
Email
hermann.full@slk-kliniken.de
Facility Name
Gemeinschaftskrankenhaus Herdecke, Kinderabteilung
City
Herdecke
ZIP/Postal Code
58313
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alfred Längler
Phone
+49 233062
Ext
3893
Email
a.laengler@gemeinschaftskrankenhaus.de
Facility Name
Universitaetsklinikum des Saarlandes
City
Homburg
ZIP/Postal Code
66421
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Norbert Graf
Phone
49-6841-168-8397
Facility Name
Klinikum, der Friedrich-Schiller-Universität, Klinik für Kinder- und Jugendmedizin
City
Jena
ZIP/Postal Code
7740
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernd Gruhn
Phone
+49 364193
Ext
8220
Email
bernd.gruhn@med.uni-jena.de
Facility Name
Staedtisches Klinikum Karlsruhe gGmbH
City
Karlsruhe
ZIP/Postal Code
76133
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A. Leipold
Phone
49-721-9740
Facility Name
Klinikum Kassel
City
Kassel
ZIP/Postal Code
D-34125
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michaela Nathrath, MD
Phone
49-561-980-3382
Facility Name
Klinik für Allgemeine Paediatrie, Univ.-Klinikum Schleswig-Holstein, Campus Kiel
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Schrappe
Phone
+49 431597
Ext
1620
Email
m.schrappe@pediatrics.uni-kiel.de
Facility Name
Kliniken der Stadt Köln GmbH, Kinderkrankenhaus Riehl
City
Köln
ZIP/Postal Code
50735
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aram Prokop
Phone
+49 2218907
Ext
5158
Email
prokopa@klinken-koeln.de
Facility Name
Med. Einrichtungen der Universität zu Köln, Klinik für Allg. Kinderheilkunde, Onkologisch-hämatologische Station
City
Köln
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thorsten Simon
Phone
+49 221478
Ext
4380
Email
thorsten.simon@uk-koeln.de
Facility Name
Department für Frauen- und Kindermedizin, Abteilung für Pädiatrische Onkologie, Hämatologie und Hämostaseologie
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lars Fischer
Phone
0341-97 26
Facility Name
Universität zu Lübeck, Klinik für Kinder- u. Jugendmedizin, Abt. Hämatologie/ Onkologie/Immunologie
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melchior Lauten
Phone
+49 451500
Ext
2557
Email
lauten@paedia.ukl.mu-luebeck.de
Facility Name
Universitätsklinikum Magdeburg, Klinik für Päd. Hämatologie/Onkologie
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Vorwerk
Phone
+49 391671
Ext
7210
Email
peter.vorwerk@med.ovgu.de
Facility Name
Klinikum Mannheim gGmbH, Kinderklinik, Abt. Hämatologie/Onkologie
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthias Dürken
Phone
+49 621383
Ext
2244
Email
matthias.duerken@kikli.ma.uni-heidelberg.de
Facility Name
Universitätsklinikum
City
Mannheim
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthias Dürken, Dr.
Facility Name
Johannes Wesling Klinikum Minden
City
Minden
ZIP/Postal Code
32429
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernhard Erdlenbruch
Phone
+49 571
Ext
8010
Email
bernhard.erdlenbruch@klinikum-minden.de
Facility Name
Städt. Krankenhaus München GmbH, Krankenhaus München-Schwabingen, Kinderklinik d. TU
City
München
ZIP/Postal Code
80804
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela Wawer
Phone
+49 893068
Ext
2261
Email
angela.wawer@lrz.tum.de
Facility Name
Ludwig-Maximilian-Universität, Dr. von Haunersches Kinderspital
City
München
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tobias Feuchtinger
Facility Name
Universitäts-Kinderklinik, Päd. Hämatologie und Onkologie
City
Münster
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudia Rössig
Phone
+49 251834
Ext
5644
Email
rossig@ukmuenster.de
Facility Name
Cnopf'sche Kinderklinik, Onkologie
City
Nürnberg
ZIP/Postal Code
90419
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wolfram Scheurlen
Phone
+49 91133
Ext
40323
Email
wolfram.scheurlen@diakonieneudettelsau.de
Facility Name
Klinikum Oldenburg gGmbH, Zentrum für Kinder- u. Jugendmedizin, (Elisabeth Kinderkrankenhaus)
City
Oldenburg
ZIP/Postal Code
26133
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hermann Müller
Phone
+49 441403
Ext
2013
Email
mueller.hermann@klinikum-oldenburg.de
Facility Name
Universitätsklinikum
City
Regensburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Selim Corbacioglu, Dr.
Facility Name
Universitäts-Kinderklinik
City
Rostock
ZIP/Postal Code
18055
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carl-Friedrich Classen
Phone
+49 381494
Ext
7000
Email
carl-friedrich.classen@med.uni-rostock.de
Facility Name
Asklepios-Klinik, Sankt Augustin GmbH
City
Sankt Augustin
ZIP/Postal Code
53757
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Harald Reinhard
Phone
+49 224124
Ext
9304
Email
h.reinhard@asklepios.com
Facility Name
HELIOS Kliniken Schwerin, Klinik f. Kinder-u. Jugendmedizin
City
Schwerin
ZIP/Postal Code
19049
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Güttel
Phone
+49 385520
Ext
2710
Email
christian.guettel@helios-kliniken.de
Facility Name
Olga-Hospital, Kinderklinik, Pädiatrisches Zentrum, Abt. Hämatologie/Onkologie
City
Stuttgart
ZIP/Postal Code
70176
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Bielack
Phone
+49 711992
Ext
2461
Email
st.bielack@olgahospital.de
Facility Name
Krankenanstalt Trier, Mutterhaus der Borromaeerinnen, Pädiatrische Abteilung
City
Trier
ZIP/Postal Code
54290
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Weis
Phone
+49 651947
Ext
2654
Email
weis@mutterhaus.de
Facility Name
Universitaetsklinikum Tuebingen
City
Tuebingen
ZIP/Postal Code
D-72076
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Ebinger, MD
Facility Name
Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
City
Ulm
ZIP/Postal Code
D-89075
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Klaus M. Debatin, MD
Phone
49-731-5000
Email
klaus-michael.debatin@medizin.uni-ulm.de
Facility Name
Stadtkrankenhaus, Kinderklinik
City
Wolfsburg
ZIP/Postal Code
38440
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sally Mukodzi
Phone
+49 5361
Ext
8000
Email
sally.mukidzi@klinikum-wolfsburg.de
Facility Name
Universitaets - Kinderklinik Wuerzburg
City
Wuerzburg
ZIP/Postal Code
D-97080
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
P. G. Schlegel, MD
Phone
49-931-2012-7856
Email
schlegel@mail.uni-wuerzburg.de
Facility Name
Soroka University Medical Center
City
Beer Sheva
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Kapelushnik
Facility Name
Rambam Health Care Campus
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nira Arad-Cohen
Facility Name
Hadassah Medical center
City
Jerusalem
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gal Goldstein
Facility Name
Schneider Children Medical Center of Israel
City
Petach-Tikva
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gil Gilad
Facility Name
Sheba Medical Center Tel-Hashomer
City
Ramat Gan
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bella Bielorai
Facility Name
Dana children hospital
City
Tel-Aviv
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronit Elhasid
Facility Name
Azienda ospedali riuniti
City
Ancona
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paolo Pierani
Facility Name
AOUC Policlinico Bari
City
Bari
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicola Santoro
Facility Name
A.O. Papa Giovanni XXIII
City
Bergamo
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Massimo Provenzi
Facility Name
Università di Bologna
City
Bologna
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Pession
Facility Name
ASST Spedali Civili di Brescia
City
Brescia
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fulvio Porta
Facility Name
Ospedale Businco
City
Cagliari
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosa Maria Mura
Facility Name
Azienda ospedaliero universitaria
City
Catania
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luca Lo Nigro
Facility Name
AO Pugliese Ciaccio
City
Catanzaro
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caterina Consarino
Facility Name
S.O. Annunziata - A. O. Cosenza
City
Cosenza
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Domenico Sperlì
Facility Name
Ospedale Meyer
City
Firenze
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tommaso Casini
Facility Name
Istituto Giannina Gaslini
City
Genova
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Concetta Micalizzi
Facility Name
Policlinico di Modena Azienda Ospedaliero-Universitaria
City
Modena
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica Cellini
Facility Name
Clinica pediatrica Fondazione MBBM
City
Monza
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Biondi
Facility Name
A.O.U. Vanvitelli
City
Napoli
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesca Rossi
Facility Name
AORN Santobono Pausilipon
City
Napoli
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosanna Parasole
Facility Name
Azienda ospedaliera di Padova
City
Padova
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Caterina Putti
Facility Name
Ospedale Civico ARNAS Civico e Di Cristina
City
Palermo
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ottavio Ziino
Facility Name
Azienda ospedaliero-universitaria di Parma
City
Parma
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angelica Barone
Facility Name
Fondazione IRCCS Policlinico San Matteo
City
Pavia
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marco Zecca
Facility Name
Ospedale S. Maria della misericordia
City
Perugia
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maurizio Caniglia
Facility Name
Ospedale Civile di Pescara
City
Pescara
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniela Onofrillo
Facility Name
Ospedale Santa Chiara Pisa
City
Pisa
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emanuela De Marco
Facility Name
Grande ospedale metropolitano B-M-M
City
Reggio Calabria
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesca Ronco
Facility Name
Ospedale infermi
City
Rimini
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberta Pericoli
Facility Name
Fondazione Policlinico Gemelli
City
Roma
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Ruggiero
Facility Name
Ospedale Bambino Gesù
City
Roma
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franco Locatelli
Facility Name
Policlinico Umberto I Università Sapienza di Roma
City
Roma
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robin Foà
Facility Name
Ospedale "Casa sollievo della sofferenza"
City
San Giovanni Rotondo
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saverio Ladogana
Facility Name
A.O.U. Città della salute e della scienza di Torino
City
Torino
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franca Fagioli
Facility Name
IRCCS Burlo Garofolo
City
Trieste
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valentina Kiren
Facility Name
AOU Verona
City
Verona
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simone Cesaro
Facility Name
Klinika pediatrickej hematológie a onkológie SZU a DFNsP
City
Banská Bystrica
Country
Slovakia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva Bubanská
Facility Name
Comenius University Children's Hospital
City
Bratislava
Country
Slovakia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandra Kolenova
Facility Name
Detská fakultná nemocnica Košice
City
Košice
Country
Slovakia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natália Galóová
Facility Name
Kantonsspital Aarau
City
Aarau
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katrin Scheinemann
Facility Name
Universitäts-Kinderspital beider Basel
City
Basel
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas von der Weid
Facility Name
Ospedale San Giovanni Bellinzona
City
Bellinzona
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierluigi Brazzola
Facility Name
Inselspital Bern
City
Bern
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jochen Rössler
Facility Name
HUG Hôpitaux Universitaires de Gèneve
City
Genève
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frederic Baleydier
Facility Name
CHUV Centre Hospitalier Universitaire Vaudois
City
Lausanne
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesco Ceppi
Facility Name
Luzerner Kantonsspital-Kinderspital Luzern
City
Luzern
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Freimut Schilling
Facility Name
Ostschweizer Kinderspital
City
St. Gallen
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeanette Greiner
Facility Name
Universitäts-Kinderspital Zürich
City
Zürich
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Felix Niggli
12. IPD Sharing Statement
Citations:
PubMed Identifier
35129146
Citation
Tufekci O, Evim MS, Gunes AM, Celkan T, Karapinar DY, Kaya Z, Baysal B, Baytan B, Kocak U, Yilmaz S, Cinar S, Oren H. Assessment of Minimal Residual Disease in Childhood Acute Lymphoblastic Leukemia: A Multicenter Study From Turkey. J Pediatr Hematol Oncol. 2022 Mar 1;44(2):e396-e402. doi: 10.1097/MPH.0000000000002419.
Results Reference
derived
Learn more about this trial
Treatment Protocol for Children and Adolescents With Acute Lymphoblastic Leukemia - AIEOP-BFM ALL 2017
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