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MRD/Risk-oriented Therapy of Adult Ph- ALL Including Pegylated Asparaginase and Lineage-targeted Methotrexate (LAL1913)

Primary Purpose

Untreated Philadelphia Positive Acute Lymphoblastic Leukemia, De Novo, Secondary

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Prephase PDN + CY
Cycle 1 Induction
Cycle 2 Induction / Early consolidation
Cycle 3 Early consolidation
Cycle 4 Consolidation
Cycle 5 Consolidation
Cycle 6 Consolidation
Cycle 7 Consolidation
Cycle 8 Reinduction
Maintenance
Allogeneic SCT or Autologous SCT
Sponsored by
Gruppo Italiano Malattie EMatologiche dell'Adulto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Untreated Philadelphia Positive Acute Lymphoblastic Leukemia focused on measuring Untreated philadelphia positive acute lymphoblastic leukemia, De novo, Secondary, Low-dose corticosteroids pretreatment, Pegylated asparaginase, Lineage-targeted risk and minimal residual disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Signed written informed consent according to ICH/EU/GCP and national local laws.
  • Age 18-65 years.
  • A diagnosis of untreated Ph- ALL or LL is required, either de novo or secondary to chemo-radiotherapy for other cancer. Pretreatment with low-dose corticosteroids in patients presenting with hyperleukocytosis is allowed. All diagnostic procedures need to be performed on freshly obtained bone marrow (BM) and peripheral blood (PB) samples. The diagnosis must be one of: de novo ALL, secondary ALL, B-/T-cell LL Full cytological, cytochemical, cytogenetic and immunobiological disease characterization according to EGIL and WHO classifications. Bone marrow and peripheral blood sampling (ALL) or biopsy specimen (LL) are required for MRD study. Detailed indications on patient registration, storage of representative diagnostic material and diagnostic work-up, including the forwarding of samples for MRD study are given in Appendix B.
  • Bone marrow and peripheral blood sampling (ALL) or biopsy specimen (LL) for MRD study.
  • ECOG performance status 0-2, unless a performance of 3 is unequivocally caused by the disease itself and not by preexisting comorbidity, and is considered and/or documented to be reversible following the application of antileukemic therapy and appropriate supportive measures.

Exclusion Criteria:

  • Diagnosis of Burkitt's leukemia or lymphoma.
  • Down's syndrome
  • Pre-existing, uncontrolled pathology such as heart failure (congestive/ischemic, acute myocardial infarction within the past 3 months, untreatable arrhythmias, NYHA classes III and IV), severe liver disease with serum bilirubin >3 mg/dL and/or ALT >3 x upper normal limit (unless attributable to ALL), kidney function impairment with serum creatinine >2 mg/dL (unless attributable to ALL), and severe neuropsychiatric disorder that impairs the patient's ability to understand and sign the informed consent, or to cope with the intended treatment plan. N.B. For altered liver and kidney function tests, eligibility criteria can be reassessed at 24-96 hours, following the institution of adequate supportive measures.
  • Pre-existing HIV positive serology (i.e. already known before enrolment). If HIV positivity is detected after enrolment, the patient is sent off study.
  • A history of cancer that is not in a remission phase following surgery and/or radiotherapy and/or chemotherapy, with life expectancy <1 year.
  • Pregnancy declared by the patient herself, unless a decision is taken with the patient to induce a therapeutic abortion in order to carry on with ALL therapy. A pregnancy test is performed at diagnosis but does not preclude the enrolment into study. Fertile patients will be advised to adopt contraceptive methods while on treatment.

Sites / Locations

  • S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo
  • Azienda Ospedaliero - Universitaria Ospedali Riuniti Umberto I - G.M. LANCISI - G. SALESI
  • U.O.C. Ematologia e Terapia Cellulare - Ospedale "C. e G. Mazzoni" di Ascoli Piceno
  • Az.Ospedaliera S.G.Moscati
  • UO Ematologia con trapianto-Università degli Studi di Bari Aldo Moro
  • Azienda Ospedaliera - Papa Giovanni XXIII
  • Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi
  • Comprensorio Sanitario di Bolzano - Azienda Sanitaria dell'Alto Adige - Ematologia e Centro TMO - Ospedale S.Maurizio
  • Spedali Civili - Brescia - Azienda Ospedaliera - U.O. Ematologia
  • Divisione di Ematologia Ospedale A. Perrino
  • Ao Brotzu, Presidio Ospedaliero A. Businco - Cagliari - Sc Ematologia E Ctmo
  • CTMO - Ematologia - Ospedale "Binaghi"
  • Unità Operativa Complessa di Onco-Ematologia - A.O. S.Anna e S.Sebastiano
  • Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"
  • Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova
  • Sezione di Ematologia C.T.M.O. Istituti Ospitalieri
  • S.C. Ematologia ASO S. Croce e Carle
  • IRCCS_AOU San Martino-IST.Clinica Ematologica
  • ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE
  • Divisione di Ematologia - Azienda Ospedaliera Ospedali Riuniti "Papardo Piemonte" P.O. Papardo
  • U.O. di Ematologia- Ospedale dell'Angelo - Mestre
  • Fondazione Irccs Ca' Granda, Ospedale Maggiore Policlinico - Milano - Ematologia - Padiglione Marcora
  • Ospedale Niguarda " Ca Granda" - SC Ematologia Blocco SUD, Ponti Est, Scala E, 4° piano
  • U.O. Ematologia e Trapianto di MIdollo - Ist.Scientifico Ospedale San Raffaele
  • UO Ematologia - AOU Policlinico di Modena
  • Azienda Ospedaliera "S.Gerardo"
  • Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"
  • S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
  • U.O. CTMO Ematologia - Osp. S.Francesco
  • Dip. di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga-Medicina Interna 2
  • Università degli Studi di Padova - Ematologia ed Immunologia Clinica
  • Ospedali Riuniti "Villa Sofia-Cervello"
  • U.O. di Ematologia con trapianto - Centro di Riferimento Regionale per le coagulopatie rare nel bambino e nell'adulto Dipart. Biomedico di Medicina Interna - A.U. Policlinico "Paolo Giaccone"
  • Casa Di Cura La Maddalena S.P.A. - Dipartimento Oncologico Di Iii Livello - Palermo - Uo Oncoematologia E Tmo
  • Day Hospital dell'U.O.C di Ematologia e CTMO Padiglione 1 TORRE DELLE MEDICINE, 6° piano
  • S.C. Ematologia - Fondazione IRCCS Policlinico S. Matteo
  • Sezione di Ematologia ed Immunologia Clinica - Ospedale S.Maria della Misericordia
  • Div. di Ematologia di Muraglia - CTMO Ospedale San Salvatore
  • U.O. Ematologia Clinica - Azienda USL di Pescara
  • Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale G. da Saliceto
  • Università di Pisa - Azienda Ospedaliera Pisana - Dipartimento di Oncologia, dei Trapianti e delle nuove Tecnologie in Medicina - Divisione di Ematologia
  • Ematologia - Ospedale San Carlo
  • Dipartimento Oncologico - Ospedale S.Maria delle Croci
  • Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"
  • Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova
  • Ospedale "Infermi"
  • Az. Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia
  • Complesso Ospedaliero S. Giovanni Addolorata
  • S.C. di Ematologia e Trapianti - I.F.O. Istituto Nazionale Tumori Regina Elena
  • U.O.C. Ematologia - Ospedale S.Eugenio
  • Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia
  • Sezione di Ematologia Cancer Center Humanitas
  • UOC di Ematologia e Trapianti di Cellule Staminali Emopoietiche - AOU San Giovanni di Dio e Ruggi D'Aragona
  • Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
  • U.O.C. Ematologia e Trapianti - A.O. Senese - Policlinico " Le Scotte"
  • Dipartimento di Oncologia ed Ematologia S.C. Ematologia 2 A.O. Città della Salute e della Scienza di Torino San Giovanni Battista
  • Divisione di Ematologia dell' Università degli Studi di Torino - "Città della Salute e della Scienza di Torino"
  • Ospedale Mauriziano Umberto I - Torino - Scdu Ematologia
  • U.L.S.S. 9 UOC Ematologia - Ospedale Ca' Foncello
  • Clinica Ematologica-Centro Trapianti e Terapie cellulari Azienda Ospedaliero-Universitaria, Udine
  • Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study population

Arm Description

In this phase II multicentric trial, eligible patients with Ph- ALL/LL will receive homogeneous supportive care and chemotherapy and will be homogeneously analyzed for response at prefixed timepoints from induction day 1. For risk-/MRD-oriented therapy, CR patients will be stratified by risk class according to diagnostic characteristics, MRD study and CT/PET (LL only) results during early consolidation.

Outcomes

Primary Outcome Measures

Number of patients on disease free survival (DFS).
DFS is defined as the time interval between the evaluation of CR and relapse of the disease or death in first Complete Response (CR); patients still alive, in first CR, will be censored at the time of the last follow-up. In this case, the DFS will be truncated at 2 years.

Secondary Outcome Measures

The rate of patients in complete remission (CR).
The rate of early bone marrow MRD negativity.
Early bone marrow MRD response (<10-4).
Overall Survival (OS) estimation.
Cumulative Incidence of Relapse (CIR) estimation.
The rate of patients dead due Treatment-related mortality (TRM).
Composite DFS, OS, CIR.
Description of Minimal Residual Disease (MRD) monitoring.
Number of Severe Infections (SI) during treatment.
Description: Number and type.
Rate of Adverse Events (AE).
Excluding SI.
Composite evaluation of impact of age (≤55 and >55) and risk category group (SR, HR, VHR - as defined) on outcomes: DFS, CIR.

Full Information

First Posted
February 17, 2014
Last Updated
September 6, 2021
Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
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1. Study Identification

Unique Protocol Identification Number
NCT02067143
Brief Title
MRD/Risk-oriented Therapy of Adult Ph- ALL Including Pegylated Asparaginase and Lineage-targeted Methotrexate
Acronym
LAL1913
Official Title
National Treatment Program of Philadelphia Chromosome-negative Adult Acute Lymphoblastic Leukemia With Pegylated Asparaginase Added to a Lineage-Targeted Risk- and Minimal Residual Disease-Oriented Strategy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
May 20, 2014 (Actual)
Primary Completion Date
October 7, 2016 (Actual)
Study Completion Date
December 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will be conducted in different centres and will study adult patients with Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL). The study treatment will include a induction/consolidation therapy incorporating pegylated Asparaginase (Peg-ASP) and lineage-targeted high-dose methotrexate plus other antileukemic drugs, for the achievement of an early negative minimal residual disease (MRD) status. The MRD study supports a risk/MRD-oriented final consolidation phase.
Detailed Description
The aim of this clinical study in adult ALL is to improve , by risk category, the overall disease-free survival in relation to the achievement of an early MRD negative status and following induction/consolidation with Peg-ASP, lineage-targeted methotrexate infusions and other disease-specific therapeutic elements, with or without the application of allogeneic or autologous SCT depending on risk class and MRD study results. A survey of severe infections occurring along the entire chemotherapy and stem cell transplant program and until 2 years from the achievement of CR will be performed with the aim to increase the knowledge of these complications and to evaluate their impact on the antileukemic program and on the long term outcome of the underlying malignancy. The prospective survey of severe infections will be performed as an ancillary observational objective of the present study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Untreated Philadelphia Positive Acute Lymphoblastic Leukemia, De Novo, Secondary, Low-dose Corticosteroids Pretreatment
Keywords
Untreated philadelphia positive acute lymphoblastic leukemia, De novo, Secondary, Low-dose corticosteroids pretreatment, Pegylated asparaginase, Lineage-targeted risk and minimal residual disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
204 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study population
Arm Type
Experimental
Arm Description
In this phase II multicentric trial, eligible patients with Ph- ALL/LL will receive homogeneous supportive care and chemotherapy and will be homogeneously analyzed for response at prefixed timepoints from induction day 1. For risk-/MRD-oriented therapy, CR patients will be stratified by risk class according to diagnostic characteristics, MRD study and CT/PET (LL only) results during early consolidation.
Intervention Type
Drug
Intervention Name(s)
Prephase PDN + CY
Intervention Type
Drug
Intervention Name(s)
Cycle 1 Induction
Other Intervention Name(s)
VCR + IDR + DXM + ASP + IT
Intervention Type
Drug
Intervention Name(s)
Cycle 2 Induction / Early consolidation
Other Intervention Name(s)
IDR + CY + ARA-C + ASP + 6MP + DXM + IT
Intervention Type
Drug
Intervention Name(s)
Cycle 3 Early consolidation
Other Intervention Name(s)
MTX + ARA-C
Intervention Type
Drug
Intervention Name(s)
Cycle 4 Consolidation
Other Intervention Name(s)
VCR + IDR + CY + ARA-C + 6-MP + DXM + IT
Intervention Type
Drug
Intervention Name(s)
Cycle 5 Consolidation
Other Intervention Name(s)
MTX + ASP + 6-MP
Intervention Type
Drug
Intervention Name(s)
Cycle 6 Consolidation
Other Intervention Name(s)
VCR + IDR + CY + ARA-C + ASP + 6MP + DXM + IT
Intervention Type
Drug
Intervention Name(s)
Cycle 7 Consolidation
Other Intervention Name(s)
MTX + ARA-C
Intervention Type
Drug
Intervention Name(s)
Cycle 8 Reinduction
Other Intervention Name(s)
VCR + IDR + DXM + PDN + CY + IT
Intervention Type
Drug
Intervention Name(s)
Maintenance
Other Intervention Name(s)
CY or VP and 6MP/MTX + 12 cycles of 6MP/MTX
Intervention Description
If MRD negative MRD u/k SR
Intervention Type
Procedure
Intervention Name(s)
Allogeneic SCT or Autologous SCT
Other Intervention Name(s)
+ Maintenance
Intervention Description
If MRD positive MRD u/k HR
Primary Outcome Measure Information:
Title
Number of patients on disease free survival (DFS).
Description
DFS is defined as the time interval between the evaluation of CR and relapse of the disease or death in first Complete Response (CR); patients still alive, in first CR, will be censored at the time of the last follow-up. In this case, the DFS will be truncated at 2 years.
Time Frame
At two years.
Secondary Outcome Measure Information:
Title
The rate of patients in complete remission (CR).
Time Frame
After approximately two months from start of treatment.
Title
The rate of early bone marrow MRD negativity.
Time Frame
At 4 timepoints (week 4, 10, 16 22).
Title
Early bone marrow MRD response (<10-4).
Time Frame
At 4 weeks following induction cycle 1 with Peg-ASP.
Title
Overall Survival (OS) estimation.
Time Frame
At two years from diagnosis.
Title
Cumulative Incidence of Relapse (CIR) estimation.
Time Frame
At two years from CR achievement.
Title
The rate of patients dead due Treatment-related mortality (TRM).
Time Frame
By the end of the study (4.5 years from first centre opened).
Title
Composite DFS, OS, CIR.
Time Frame
At two years from CR achievement and rate of TRM in LL patients.
Title
Description of Minimal Residual Disease (MRD) monitoring.
Time Frame
During treatment at time point 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12.
Title
Number of Severe Infections (SI) during treatment.
Description
Description: Number and type.
Time Frame
At the end of the study (4.5 years from first centre opened).
Title
Rate of Adverse Events (AE).
Description
Excluding SI.
Time Frame
By the end of the study (4.5 years from first centre opened)
Title
Composite evaluation of impact of age (≤55 and >55) and risk category group (SR, HR, VHR - as defined) on outcomes: DFS, CIR.
Time Frame
At two years for CR achievement, OS at two years from diagnosis and TRM.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed written informed consent according to ICH/EU/GCP and national local laws. Age 18-65 years. A diagnosis of untreated Ph- ALL or LL is required, either de novo or secondary to chemo-radiotherapy for other cancer. Pretreatment with low-dose corticosteroids in patients presenting with hyperleukocytosis is allowed. All diagnostic procedures need to be performed on freshly obtained bone marrow (BM) and peripheral blood (PB) samples. The diagnosis must be one of: de novo ALL, secondary ALL, B-/T-cell LL Full cytological, cytochemical, cytogenetic and immunobiological disease characterization according to EGIL and WHO classifications. Bone marrow and peripheral blood sampling (ALL) or biopsy specimen (LL) are required for MRD study. Detailed indications on patient registration, storage of representative diagnostic material and diagnostic work-up, including the forwarding of samples for MRD study are given in Appendix B. Bone marrow and peripheral blood sampling (ALL) or biopsy specimen (LL) for MRD study. ECOG performance status 0-2, unless a performance of 3 is unequivocally caused by the disease itself and not by preexisting comorbidity, and is considered and/or documented to be reversible following the application of antileukemic therapy and appropriate supportive measures. Exclusion Criteria: Diagnosis of Burkitt's leukemia or lymphoma. Down's syndrome Pre-existing, uncontrolled pathology such as heart failure (congestive/ischemic, acute myocardial infarction within the past 3 months, untreatable arrhythmias, NYHA classes III and IV), severe liver disease with serum bilirubin >3 mg/dL and/or ALT >3 x upper normal limit (unless attributable to ALL), kidney function impairment with serum creatinine >2 mg/dL (unless attributable to ALL), and severe neuropsychiatric disorder that impairs the patient's ability to understand and sign the informed consent, or to cope with the intended treatment plan. N.B. For altered liver and kidney function tests, eligibility criteria can be reassessed at 24-96 hours, following the institution of adequate supportive measures. Pre-existing HIV positive serology (i.e. already known before enrolment). If HIV positivity is detected after enrolment, the patient is sent off study. A history of cancer that is not in a remission phase following surgery and/or radiotherapy and/or chemotherapy, with life expectancy <1 year. Pregnancy declared by the patient herself, unless a decision is taken with the patient to induce a therapeutic abortion in order to carry on with ALL therapy. A pregnancy test is performed at diagnosis but does not preclude the enrolment into study. Fertile patients will be advised to adopt contraceptive methods while on treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renato Bassan, Pr.
Organizational Affiliation
Azienda ULSS 12 Veneziana
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Roberto Foà, Pr.
Organizational Affiliation
Policlinico Umberto I, Hematology Department.
Official's Role
Study Director
Facility Information:
Facility Name
S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo
City
Alessandria
Country
Italy
Facility Name
Azienda Ospedaliero - Universitaria Ospedali Riuniti Umberto I - G.M. LANCISI - G. SALESI
City
Ancona
Country
Italy
Facility Name
U.O.C. Ematologia e Terapia Cellulare - Ospedale "C. e G. Mazzoni" di Ascoli Piceno
City
Ascoli Piceno
Country
Italy
Facility Name
Az.Ospedaliera S.G.Moscati
City
Avellino
Country
Italy
Facility Name
UO Ematologia con trapianto-Università degli Studi di Bari Aldo Moro
City
Bari
Country
Italy
Facility Name
Azienda Ospedaliera - Papa Giovanni XXIII
City
Bergamo
Country
Italy
Facility Name
Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi
City
Bologna
Country
Italy
Facility Name
Comprensorio Sanitario di Bolzano - Azienda Sanitaria dell'Alto Adige - Ematologia e Centro TMO - Ospedale S.Maurizio
City
Bolzano
Country
Italy
Facility Name
Spedali Civili - Brescia - Azienda Ospedaliera - U.O. Ematologia
City
Brescia
Country
Italy
Facility Name
Divisione di Ematologia Ospedale A. Perrino
City
Brindisi
Country
Italy
Facility Name
Ao Brotzu, Presidio Ospedaliero A. Businco - Cagliari - Sc Ematologia E Ctmo
City
Cagliari
Country
Italy
Facility Name
CTMO - Ematologia - Ospedale "Binaghi"
City
Cagliari
Country
Italy
Facility Name
Unità Operativa Complessa di Onco-Ematologia - A.O. S.Anna e S.Sebastiano
City
Caserta
Country
Italy
Facility Name
Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"
City
Catania
Country
Italy
Facility Name
Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova
City
Cona
Country
Italy
Facility Name
Sezione di Ematologia C.T.M.O. Istituti Ospitalieri
City
Cremona
Country
Italy
Facility Name
S.C. Ematologia ASO S. Croce e Carle
City
Cuneo
Country
Italy
Facility Name
IRCCS_AOU San Martino-IST.Clinica Ematologica
City
Genova
Country
Italy
Facility Name
ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE
City
Lecce
Country
Italy
Facility Name
Divisione di Ematologia - Azienda Ospedaliera Ospedali Riuniti "Papardo Piemonte" P.O. Papardo
City
Messina
Country
Italy
Facility Name
U.O. di Ematologia- Ospedale dell'Angelo - Mestre
City
Mestre
Country
Italy
Facility Name
Fondazione Irccs Ca' Granda, Ospedale Maggiore Policlinico - Milano - Ematologia - Padiglione Marcora
City
Milano
Country
Italy
Facility Name
Ospedale Niguarda " Ca Granda" - SC Ematologia Blocco SUD, Ponti Est, Scala E, 4° piano
City
Milano
Country
Italy
Facility Name
U.O. Ematologia e Trapianto di MIdollo - Ist.Scientifico Ospedale San Raffaele
City
Milano
Country
Italy
Facility Name
UO Ematologia - AOU Policlinico di Modena
City
Modena
Country
Italy
Facility Name
Azienda Ospedaliera "S.Gerardo"
City
Monza
Country
Italy
Facility Name
Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"
City
Napoli
Country
Italy
Facility Name
S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
City
Novara
Country
Italy
Facility Name
U.O. CTMO Ematologia - Osp. S.Francesco
City
Nuoro
Country
Italy
Facility Name
Dip. di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga-Medicina Interna 2
City
Orbassano
Country
Italy
Facility Name
Università degli Studi di Padova - Ematologia ed Immunologia Clinica
City
Padova
Country
Italy
Facility Name
Ospedali Riuniti "Villa Sofia-Cervello"
City
Palermo
Country
Italy
Facility Name
U.O. di Ematologia con trapianto - Centro di Riferimento Regionale per le coagulopatie rare nel bambino e nell'adulto Dipart. Biomedico di Medicina Interna - A.U. Policlinico "Paolo Giaccone"
City
Palermo
Country
Italy
Facility Name
Casa Di Cura La Maddalena S.P.A. - Dipartimento Oncologico Di Iii Livello - Palermo - Uo Oncoematologia E Tmo
City
Palmero
Country
Italy
Facility Name
Day Hospital dell'U.O.C di Ematologia e CTMO Padiglione 1 TORRE DELLE MEDICINE, 6° piano
City
Parma
Country
Italy
Facility Name
S.C. Ematologia - Fondazione IRCCS Policlinico S. Matteo
City
Pavia
Country
Italy
Facility Name
Sezione di Ematologia ed Immunologia Clinica - Ospedale S.Maria della Misericordia
City
Perugia
Country
Italy
Facility Name
Div. di Ematologia di Muraglia - CTMO Ospedale San Salvatore
City
Pesaro
Country
Italy
Facility Name
U.O. Ematologia Clinica - Azienda USL di Pescara
City
Pescara
Country
Italy
Facility Name
Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale G. da Saliceto
City
Piacenza
Country
Italy
Facility Name
Università di Pisa - Azienda Ospedaliera Pisana - Dipartimento di Oncologia, dei Trapianti e delle nuove Tecnologie in Medicina - Divisione di Ematologia
City
Pisa
Country
Italy
Facility Name
Ematologia - Ospedale San Carlo
City
Potenza
Country
Italy
Facility Name
Dipartimento Oncologico - Ospedale S.Maria delle Croci
City
Ravenna
Country
Italy
Facility Name
Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"
City
Reggio Calabria
Country
Italy
Facility Name
Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova
City
Reggio Emilia
Country
Italy
Facility Name
Ospedale "Infermi"
City
Rimini
Country
Italy
Facility Name
Az. Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia
City
Roma
Country
Italy
Facility Name
Complesso Ospedaliero S. Giovanni Addolorata
City
Roma
Country
Italy
Facility Name
S.C. di Ematologia e Trapianti - I.F.O. Istituto Nazionale Tumori Regina Elena
City
Roma
Country
Italy
Facility Name
U.O.C. Ematologia - Ospedale S.Eugenio
City
Roma
Country
Italy
Facility Name
Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia
City
Roma
Country
Italy
Facility Name
Sezione di Ematologia Cancer Center Humanitas
City
Rozzano
Country
Italy
Facility Name
UOC di Ematologia e Trapianti di Cellule Staminali Emopoietiche - AOU San Giovanni di Dio e Ruggi D'Aragona
City
Salerno
Country
Italy
Facility Name
Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
City
San Giovanni Rotondo
Country
Italy
Facility Name
U.O.C. Ematologia e Trapianti - A.O. Senese - Policlinico " Le Scotte"
City
Siena
Country
Italy
Facility Name
Dipartimento di Oncologia ed Ematologia S.C. Ematologia 2 A.O. Città della Salute e della Scienza di Torino San Giovanni Battista
City
Torino
Country
Italy
Facility Name
Divisione di Ematologia dell' Università degli Studi di Torino - "Città della Salute e della Scienza di Torino"
City
Torino
Country
Italy
Facility Name
Ospedale Mauriziano Umberto I - Torino - Scdu Ematologia
City
Torino
Country
Italy
Facility Name
U.L.S.S. 9 UOC Ematologia - Ospedale Ca' Foncello
City
Treviso
Country
Italy
Facility Name
Clinica Ematologica-Centro Trapianti e Terapie cellulari Azienda Ospedaliero-Universitaria, Udine
City
Udine
Country
Italy
Facility Name
Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi
City
Verona
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34048072
Citation
Piciocchi A, Messina M, Elia L, Vitale A, Soddu S, Testi AM, Chiaretti S, Mancini M, Albano F, Spadano A, Krampera M, Bonifacio M, Cairoli R, Vetro C, Colella F, Ferrara F, Cimino G, Bassan R, Fazi P, Vignetti M. Prognostic impact of KMT2A-AFF1-positivity in 926 BCR-ABL1-negative B-lineage acute lymphoblastic leukemia patients treated in GIMEMA clinical trials since 1996. Am J Hematol. 2021 Sep 1;96(9):E334-E338. doi: 10.1002/ajh.26253. Epub 2021 Jun 9. No abstract available.
Results Reference
derived
Links:
URL
http://www.gimema.it
Description
GIMEMA Foundation

Learn more about this trial

MRD/Risk-oriented Therapy of Adult Ph- ALL Including Pegylated Asparaginase and Lineage-targeted Methotrexate

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