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Phase III Trial in Acute Promyelocytic Leukemia Patients (APL0406)

Primary Purpose

Leukemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
arsenic trioxide
idarubicin
mercaptopurine
methotrexate
all-trans retinoic acid
all-trans retinoic acid (ATRA)
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 Leukemia focused on measuring adult acute promyelocytic leukemia (M3), adult acute myeloid leukemia with t(15;17)(q22;q12), untreated adult acute myeloid leukemia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

  • Signed written informed consent according to IGH/EU/GCP and national local laws
  • Newly diagnosed APL by cytomorphology, confirmed also by molecular analysis*.
  • Age ≤18 < 71 years
  • WHO performance status 0 -2 included
  • WBC at diagnosis ≤ 10 x 109/L
  • Serum total bilirubin ≤ 3.0 mg/dL (≤ 51µmol/L)
  • Serum creatinine ≤ 3.0 mg/dL (≤ 260 µmol/L)

The confirmation of diagnosis at genetic level (microspeckled PML nuclear distribution by PGM3 monoclonal antibody and/or PML/RARa fusion by RT-PCR and/or demonstration of t(15;17) by karyotyping) will be mandatory for patient eligibility. However, in order to avoid delay in treatment initiation, patients can be randomised on the basis of morphologic diagnosis only and before the results of genetic tests are available.

Exclusion criteria

  • Age < 18 and ≥ 71
  • WBC at diagnosis > 10 x 109/L
  • Other active malignancy at time of study entry
  • Lack of diagnostic confirmation at genetic level
  • Significant arrhythmias, EKG abnormalities (*see below) or neuropathy
  • Other cardiac contraindications for intensive chemotherapy (L-VEF <50%)
  • Uncontrolled, life-threatening infections
  • Severe non-controlled pulmonary or cardiac disease

  • Women who are either pregnant or breast feeding, or of child-bearing potential, defined as all women physiologically capable of becoming pregnant, UNLESS they meet one of the following definitions:

    • Amenorrhea;
    • post surgical bilateral oophorectomy with or without hysterectomy;
    • using a highly effective method of birth control (defined as those which result in a failure rate less than 1% per year) when used consistently and correctly such as implants, injectables, oral contraceptives, IUDs, sexual abstinence or vasectomized partner.
  • Concomitant severe psychiatric disorder

  • HIV positivity

    *EKG abnormalities:

    • Congenital long QT syndrome;
    • History or presence of significant ventricular or atrial tachyarrhythmia
    • Clinically significant resting bradycardia (<50 beats per minute)
    • QTc > 450 msec on screening EKG (using the QTcF formula detailed on page 18)
    • Right bundle branch block plus left anterior hemiblock, bifascicular block
  • Use of other investigational drugs at the time of enrolment or within 30 days before study entry

Sites / Locations

  • Universitätsklinik Innsbruck Hämatologie Onkologie
  • Krankenhaus der Barmherzigen Schwestern Linz
  • Universitätsklinik für Innere Medizin III Salzburg
  • Klinikum Bayreuth GmbH
  • Charité Campus Benjamin Franklin Berlin
  • Städt. Kliniken Bielefeld gem. GmbH
  • Universitätsklinikum Bonn
  • Ev. Diakonie-Krankenhaus gGmbH Bremen
  • Klinikum Bremen-Mitte gGmbH
  • Klinikum Chemnitz gGmbH
  • Universitätsklinikum C. G. Carus Dresden
  • Katholisches Klinikum Duisburg St. Johannes Hospital
  • Universitätsklinikum Düsseldorf
  • Uniklinikum Erlangen
  • Kliniken Essen Süd, Ev. Krankenhaus Essen-Werden gGmbH
  • Universitätsklinikum Essen
  • Städtische Kliniken Frankfurt a. M.-Höchst
  • Uniklinik Frankfurt/Main
  • Universitätsklinikum Freiburg
  • Klinikum Fulda
  • Universitätsklinikum Gießen und Marburg Gießen
  • Universitätsklinikum Göttingen
  • Asklepios Klinik Hamburg Altona
  • Asklepios Klinik St. Georg Hamburg
  • Universitätsklinikum Hamburg Eppendorf
  • St. Marien-Hospital gem. GmbH Hamm
  • Medizinische Hochschule Hannover
  • Universitätsklinikum Heidelberg
  • St. Bernward Krankenhaus Hildesheim
  • Universitätsklinikum des Saarlandes Homburg/Saar
  • Klinik für Knochenmarktransplantation und Hämatologie Idar-Oberstein
  • Westpfalz-Klinikum GmbH Kaiserslautern
  • Caritas-Krankenhaus Lebach
  • Klinikum Lippe Lemgo
  • Uniklinikum Lübeck
  • Klinikum der Johannes Gutenberg Universität Mainz
  • Universitätsklinikum Gießen und Marburg GmbH Marburg
  • Carl-von-Basedow-Klinikum Merseburg
  • Johannes Wesling Klinikum Minden
  • Klinikum rechts der Isar (München)
  • Klinikum Nord Nürnberg
  • Klinikum Passau
  • Universitätsklinikum Regensburg
  • Caritas-Klinik St. Theresia Saarbrücken
  • Diakonie-Krankenhaus Schwäbisch Hall
  • Diakonie-Klinikum Stuttgart
  • Klinikum Stuttgart Bürgerhospital
  • Robert Bosch Krankenhaus Stuttgart
  • Krankenanstalt Mutterhaus der Borromäerinnen Trier
  • Krankenhaus der Barmherzigen Brüder Trier
  • Universitätsklinikum Tübingen
  • Universitätsklinikum Ulm
  • Klinikum Villingen-Schwenningen
  • HELIOS Klinikum Wuppertal
  • Ospedale Civile SS. Antonio e Biagio di Alessandria
  • Ospedale Gen.le. Prov.le "C.G. Mazzoni"
  • Az.Ospedaliera S.G.Moscati
  • Ematologia con trapianto- AOU Policlinico Consorziale di Bari
  • Divisione di Ematologia - Ospedali Riuniti
  • Istituto di Ematologia e Oncologia Medica "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi
  • Azienda Sanitaria di Bolzano - Ospedale Centrale - Ematologia e Centro TMO
  • Spedali Civili di Brescia
  • ASL N.8 - Ospedale "A. Businco" - Unità Operativa di Ematologia e Trapianto di Midollo
  • Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"
  • Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia
  • Sezione di Ematologia e Fisiopatologia delle Emostasi - Azienda Ospedaliera - Arcispedale S. Anna
  • Divisione Ematologia 1 - Azienda Ospedaliera Universitaria "San Martino"
  • Divisione di Ematologia Ospedale "Santa Maria Goretti"
  • ST. V. Fazzi
  • A.O. Universitaria Policlinico Martina di Messina
  • Azienda ospedaliera Papardo
  • IRCCS Fondazione Centro S. Raffaele del Monte Tabor
  • Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia
  • UO Centro Trapianti di Midollo - IRCCS Ospedale Maggiore Policlinico
  • Centro Oncologico Modenese - Dipartimento di Oncoematologia
  • Azienda ospedaliera S. Gerardo di Monza
  • A.S.L. Napoli 1 Ospedale San Giovanni Bosco
  • Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"
  • Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia
  • Servizio Sanitario Nazionale - Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli" - Struttura Complessa di Ematologia - Div. TERE- 4° piano - Padiglione Palermo
  • ASL SA/1 di Nocera Inferiore
  • A.O. Universitaria S. Luigi Gonzaga di Orbassano
  • Divisione di Ematologia con trapianto di midollo - A.U. Policlinico "Paolo Giaccone"
  • Ospedali Riuniti "Villa Sofia-Cervello"
  • Cattedra di Ematologia CTMO Università degli Studi di Parma
  • IRCCS Policlinico S. Matteo di Pavia
  • 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
  • Ematologia - Ospedale San Carlo
  • Ospedale S. Maria delle Croci di Ravenna
  • Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"
  • IRCCS Centro di riferimento Oncologico di Basilicata
  • Azienda Osp. S. Giovanni/Addolorata
  • Divisione di Ematologia - Ospedale S. Camillo
  • Ospedale S. Eugenio
  • Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia
  • Policlinico Campus Biomedico
  • Policlinico Universitario Gemelli di Roma
  • Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia
  • Università degli Studi - Policlinico di Tor Vergata
  • IRCCS Istituto Regina Elena
  • Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
  • Serv. di Ematologia Ist. di Ematologia ed Endocrinologia
  • U.O.C. Ematologia e Trapianti - A.O. Senese - Policlinico " Le Scotte"
  • SCDO Ematologia 2 AOU S.Giovanni Battista
  • Clinica Ematologica - Policlinico Universitario
  • Ospedale di circolo e Fondazione Macchi
  • Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi
  • ULSS N.6 Osp. S. Bortolo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ARM A - ATO/ATRA

ARM B - ATRA

Arm Description

Outcomes

Primary Outcome Measures

Event-free survival
As of 14th september 2010, all patients needed to evaluate the primary endpoint have been recruited.

Secondary Outcome Measures

Rate of hematological complete remission
Overall survival rate
Rate of cumulative incidence of relapse
Incidence of hematological and non-hematological toxicity episodes during treatment as assessed by CTC-NCI
Rate of molecular remission after 3rd consolidation course
Assessment of acute promyelocytic leukemia/RARa transcript level reduction after induction and during consolidation therapy
Quality of life at the end of induction therapy and at the end of the 3rd consolidation course
Event free survival
Total hospitalization days during study therapy
Event-free survival rate in the two arms

Full Information

First Posted
June 4, 2007
Last Updated
October 10, 2022
Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
Collaborators
Study Alliance Leukemia (SAL) Group
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1. Study Identification

Unique Protocol Identification Number
NCT00482833
Brief Title
Phase III Trial in Acute Promyelocytic Leukemia Patients
Acronym
APL0406
Official Title
A Randomised Phase III Study to Compare Arsenic Trioxide (ATO) Combined to ATRA Versus Standard ATRA and Anthracycline-Based Chemotherapy (AIDA Regimen) for Newly Diagnosed, Non High-Risk Acute Promyelocytic Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
October 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
Collaborators
Study Alliance Leukemia (SAL) Group

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Open label, randomised, phase III multicenter trial.
Detailed Description
Arm I: Induction therapy: Patients receive oral tretinoin twice daily and arsenic trioxide IV over 2 hours on days 1-60. Patients achieving hematological complete remission go on to receive consolidation therapy. Consolidation therapy: Patients receive oral tretinoin twice daily on days 1-14. Treatment with tretinoin repeats every 4 weeks for up to 7 courses. Patients also receive arsenic trioxide IV over 2 hours on days 1-5 in weeks 1-4. Treatment with arsenic trioxide repeats every 8 weeks for up to 4 courses. Arm II: Induction therapy: Patients receive tretinoin as in arm I induction therapy and idarubicin IV over 20 minutes on days 2, 4, 6, and 8. Patients achieving hematological complete remission go on to receive consolidation therapy. Consolidation therapy: Patients receive oral tretinoin twice daily on days 1-45, idarubicin IV over 20 minutes on days 1-4 and day 31, and mitoxantrone hydrochloride IV over 30 minutes on days 16-20. Marrow samples are collected after completion of consolidation therapy and analyzed by reverse transcriptase-PCR for molecular remission. Patients achieving molecular remission (PML-RARa negative) go on to receive maintenance therapy. Maintenance therapy: Patients receive oral mercaptopurine once daily and methotrexate intramuscularly once weekly for 3 months. Treatment with mercaptopurine and methotrexate repeats every 3 months for 7 courses. After completion of course 1 of mercaptopurine and methotrexate, patients receive oral tretinoin once daily on days 1-15*. Treatment with tretinoin repeats every 3 months for 6 courses. NOTE: *Patients do not receive mercaptopurine and methotrexate during tretinoin administration. After completion of study therapy, patients are followed periodically for 5 years. As of 14th September 2010, all patients needed to evaluate the primary endpoint (162 patients) have been recruited but the trial accrual continued in order to assess one secondary outcome (QoL)."

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
adult acute promyelocytic leukemia (M3), adult acute myeloid leukemia with t(15;17)(q22;q12), untreated adult acute myeloid leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
276 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ARM A - ATO/ATRA
Arm Type
Experimental
Arm Title
ARM B - ATRA
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
arsenic trioxide
Intervention Description
Induction Arsenic Trioxide (As2O3=ATO), 0.15 mg/Kg IV over 2 hours daily starting on day 1. ATO will be continued until hematological CR or for a maximum of 60 days. Consolidation ATO, 0.15 mg/Kg IV over 2 hours daily for 5 days every week. Treatment will be continued for 4 weeks on and 4 weeks off, for a total of 4 cycles (last cycle administered on weeks 25 - 28).
Intervention Type
Drug
Intervention Name(s)
idarubicin
Intervention Description
Induction Idarubicin, 12 mg/m² on days 2, 4, 6 and 8 by short (20') intravenous infusion . If no hematological CR is achieved by 60 days after start of induction, patient will go off-study. Consolidation 1st cycle Idarubicin, 5 mg/m2/day by short (20') intravenous infusion on days 1, 2, 3, 4. 3rd cycle Idarubicin, 12 mg/m2/day as short (20') intravenous infusion only on day 1.
Intervention Type
Drug
Intervention Name(s)
mercaptopurine
Intervention Description
Maintenance therapy 6-Mercaptopurine (6-MP), 50 mg/m2/day orally. The dose will be adjusted according to hematopoietic toxicity during the follow-up period
Intervention Type
Drug
Intervention Name(s)
methotrexate
Intervention Description
Maintenance therapy Methotrexate (MTX), 15 mg/m2/weekly intramuscularly. The dose will be adjusted according to toxicity during the follow-up period.
Intervention Type
Drug
Intervention Name(s)
all-trans retinoic acid
Intervention Description
Induction ATRA, 45 mg/m²/day will be administered orally in two equally divided doses and rounded to the nearest 10 mg increment, starting on day 1. ATRA treatment will be continued until hematological CR and for a maximum of 60 days. Consolidation st cycle ATRA, 45 mg/m2/day, will be administered orally in two equally divided doses and rounded to the nearest 10 mg increment, starting from day 1 to day 15. nd cycle ATRA, 45 mg/m2/day will be administered orally in two equally divided doses and rounded to the nearest 10 mg increment, starting from day 1 to day 15. rd cycle ATRA, 45 mg/m2/day will be administered orally in two equally divided doses and rounded to the nearest 10 mg increment, starting from day 1 to day 15. Maintenance therapy ATRA, 45 mg/m2/day orally, for 15 days every three months until a two year period is completed.
Intervention Type
Drug
Intervention Name(s)
all-trans retinoic acid (ATRA)
Intervention Description
Induction All-trans retinoic acid (ATRA), 45 mg/m²/day will be administered orally in two equally divided doses and rounded to the nearest 10 mg increment, starting on day 1. ATRA treatment will be continued until hematological complete remission (CR, see below for definition) or for a maximum of 60 days. Consolidation ATRA, 45 mg/m²/day will be administered orally in two equally divided doses and rounded to the nearest 10 mg increment. Treatment will be administered for 2 weeks on 2 weeks off and for a total of 7 cycles (last cycle administered on weeks 25 - 26).
Primary Outcome Measure Information:
Title
Event-free survival
Description
As of 14th september 2010, all patients needed to evaluate the primary endpoint have been recruited.
Time Frame
At maximum 3.5 years from study entry
Secondary Outcome Measure Information:
Title
Rate of hematological complete remission
Time Frame
At maximum 60 days from induction therapy start
Title
Overall survival rate
Time Frame
At 2 years from study entry
Title
Rate of cumulative incidence of relapse
Time Frame
At 2 years from study entry
Title
Incidence of hematological and non-hematological toxicity episodes during treatment as assessed by CTC-NCI
Time Frame
At maximum 60 days from induction therapy start and at maximum 225 days from consolidation therapy start
Title
Rate of molecular remission after 3rd consolidation course
Time Frame
At maximum 225 days grom consolidation therapy start
Title
Assessment of acute promyelocytic leukemia/RARa transcript level reduction after induction and during consolidation therapy
Time Frame
At maximum 60 days from induction therapy start and at maximum 225 days from consolidation therapy start
Title
Quality of life at the end of induction therapy and at the end of the 3rd consolidation course
Time Frame
At maximum 60 days from induction therapy start and at maximum 225 days from consolidation therapy start
Title
Event free survival
Time Frame
At 2 years from study entry
Title
Total hospitalization days during study therapy
Time Frame
At maximum 3.5 years from study entry
Title
Event-free survival rate in the two arms
Time Frame
At 2 years from study entry

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria Signed written informed consent according to IGH/EU/GCP and national local laws Newly diagnosed APL by cytomorphology, confirmed also by molecular analysis*. Age ≤18 < 71 years WHO performance status 0 -2 included WBC at diagnosis ≤ 10 x 109/L Serum total bilirubin ≤ 3.0 mg/dL (≤ 51µmol/L) Serum creatinine ≤ 3.0 mg/dL (≤ 260 µmol/L) The confirmation of diagnosis at genetic level (microspeckled PML nuclear distribution by PGM3 monoclonal antibody and/or PML/RARa fusion by RT-PCR and/or demonstration of t(15;17) by karyotyping) will be mandatory for patient eligibility. However, in order to avoid delay in treatment initiation, patients can be randomised on the basis of morphologic diagnosis only and before the results of genetic tests are available. Exclusion criteria Age < 18 and ≥ 71 WBC at diagnosis > 10 x 109/L Other active malignancy at time of study entry Lack of diagnostic confirmation at genetic level Significant arrhythmias, EKG abnormalities (*see below) or neuropathy Other cardiac contraindications for intensive chemotherapy (L-VEF <50%) Uncontrolled, life-threatening infections Severe non-controlled pulmonary or cardiac disease Women who are either pregnant or breast feeding, or of child-bearing potential, defined as all women physiologically capable of becoming pregnant, UNLESS they meet one of the following definitions: Amenorrhea; post surgical bilateral oophorectomy with or without hysterectomy; using a highly effective method of birth control (defined as those which result in a failure rate less than 1% per year) when used consistently and correctly such as implants, injectables, oral contraceptives, IUDs, sexual abstinence or vasectomized partner. Concomitant severe psychiatric disorder HIV positivity *EKG abnormalities: Congenital long QT syndrome; History or presence of significant ventricular or atrial tachyarrhythmia Clinically significant resting bradycardia (<50 beats per minute) QTc > 450 msec on screening EKG (using the QTcF formula detailed on page 18) Right bundle branch block plus left anterior hemiblock, bifascicular block Use of other investigational drugs at the time of enrolment or within 30 days before study entry
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco Lo Coco, MD
Organizational Affiliation
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Official's Role
Study Chair
Facility Information:
Facility Name
Universitätsklinik Innsbruck Hämatologie Onkologie
City
Innsbruck
Country
Austria
Facility Name
Krankenhaus der Barmherzigen Schwestern Linz
City
Linz
Country
Austria
Facility Name
Universitätsklinik für Innere Medizin III Salzburg
City
Salzburg
Country
Austria
Facility Name
Klinikum Bayreuth GmbH
City
Bayreuth
Country
Germany
Facility Name
Charité Campus Benjamin Franklin Berlin
City
Berlin
Country
Germany
Facility Name
Städt. Kliniken Bielefeld gem. GmbH
City
Bielefeld
Country
Germany
Facility Name
Universitätsklinikum Bonn
City
Bonn
Country
Germany
Facility Name
Ev. Diakonie-Krankenhaus gGmbH Bremen
City
Bremen
Country
Germany
Facility Name
Klinikum Bremen-Mitte gGmbH
City
Bremen
Country
Germany
Facility Name
Klinikum Chemnitz gGmbH
City
Chemnitz
Country
Germany
Facility Name
Universitätsklinikum C. G. Carus Dresden
City
Dresden
Country
Germany
Facility Name
Katholisches Klinikum Duisburg St. Johannes Hospital
City
Duisburg
Country
Germany
Facility Name
Universitätsklinikum Düsseldorf
City
Düsseldorf
Country
Germany
Facility Name
Uniklinikum Erlangen
City
Erlangen
Country
Germany
Facility Name
Kliniken Essen Süd, Ev. Krankenhaus Essen-Werden gGmbH
City
Essen
Country
Germany
Facility Name
Universitätsklinikum Essen
City
Essen
Country
Germany
Facility Name
Städtische Kliniken Frankfurt a. M.-Höchst
City
Frankfurt/a. M. -Höchst
Country
Germany
Facility Name
Uniklinik Frankfurt/Main
City
Frankfurt/Main
Country
Germany
Facility Name
Universitätsklinikum Freiburg
City
Freiburg
Country
Germany
Facility Name
Klinikum Fulda
City
Fulda
Country
Germany
Facility Name
Universitätsklinikum Gießen und Marburg Gießen
City
Gießen
Country
Germany
Facility Name
Universitätsklinikum Göttingen
City
Göttingen
Country
Germany
Facility Name
Asklepios Klinik Hamburg Altona
City
Hamburg
Country
Germany
Facility Name
Asklepios Klinik St. Georg Hamburg
City
Hamburg
Country
Germany
Facility Name
Universitätsklinikum Hamburg Eppendorf
City
Hamburg
Country
Germany
Facility Name
St. Marien-Hospital gem. GmbH Hamm
City
Hamm
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
Country
Germany
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
Country
Germany
Facility Name
St. Bernward Krankenhaus Hildesheim
City
Hildesheim
Country
Germany
Facility Name
Universitätsklinikum des Saarlandes Homburg/Saar
City
Homburg
Country
Germany
Facility Name
Klinik für Knochenmarktransplantation und Hämatologie Idar-Oberstein
City
Idar-Oberstein
Country
Germany
Facility Name
Westpfalz-Klinikum GmbH Kaiserslautern
City
Kaiserslautern
Country
Germany
Facility Name
Caritas-Krankenhaus Lebach
City
Lebach
Country
Germany
Facility Name
Klinikum Lippe Lemgo
City
Lippe
Country
Germany
Facility Name
Uniklinikum Lübeck
City
Lübeck
Country
Germany
Facility Name
Klinikum der Johannes Gutenberg Universität Mainz
City
Mainz
Country
Germany
Facility Name
Universitätsklinikum Gießen und Marburg GmbH Marburg
City
Marburg
Country
Germany
Facility Name
Carl-von-Basedow-Klinikum Merseburg
City
Merseburg
Country
Germany
Facility Name
Johannes Wesling Klinikum Minden
City
Minden
Country
Germany
Facility Name
Klinikum rechts der Isar (München)
City
München
Country
Germany
Facility Name
Klinikum Nord Nürnberg
City
Nürnberg
Country
Germany
Facility Name
Klinikum Passau
City
Passau
Country
Germany
Facility Name
Universitätsklinikum Regensburg
City
Regensburg
Country
Germany
Facility Name
Caritas-Klinik St. Theresia Saarbrücken
City
Saarbrücken
Country
Germany
Facility Name
Diakonie-Krankenhaus Schwäbisch Hall
City
Schwäbisch-Hall
Country
Germany
Facility Name
Diakonie-Klinikum Stuttgart
City
Stuttgart
Country
Germany
Facility Name
Klinikum Stuttgart Bürgerhospital
City
Stuttgart
Country
Germany
Facility Name
Robert Bosch Krankenhaus Stuttgart
City
Stuttgart
Country
Germany
Facility Name
Krankenanstalt Mutterhaus der Borromäerinnen Trier
City
Trier
Country
Germany
Facility Name
Krankenhaus der Barmherzigen Brüder Trier
City
Trier
Country
Germany
Facility Name
Universitätsklinikum Tübingen
City
Tübingen
Country
Germany
Facility Name
Universitätsklinikum Ulm
City
Ulm
Country
Germany
Facility Name
Klinikum Villingen-Schwenningen
City
Villingen-Schwenningen
Country
Germany
Facility Name
HELIOS Klinikum Wuppertal
City
Wuppertal
Country
Germany
Facility Name
Ospedale Civile SS. Antonio e Biagio di Alessandria
City
Alessandria
Country
Italy
Facility Name
Ospedale Gen.le. Prov.le "C.G. Mazzoni"
City
Ascoli Piceno
Country
Italy
Facility Name
Az.Ospedaliera S.G.Moscati
City
Avellino
Country
Italy
Facility Name
Ematologia con trapianto- AOU Policlinico Consorziale di Bari
City
Bari
Country
Italy
Facility Name
Divisione di Ematologia - Ospedali Riuniti
City
Bergamo
Country
Italy
Facility Name
Istituto di Ematologia e Oncologia Medica "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi
City
Bologna
Country
Italy
Facility Name
Azienda Sanitaria di Bolzano - Ospedale Centrale - Ematologia e Centro TMO
City
Bolzano
Country
Italy
Facility Name
Spedali Civili di Brescia
City
Brescia
Country
Italy
Facility Name
ASL N.8 - Ospedale "A. Businco" - Unità Operativa di Ematologia e Trapianto di Midollo
City
Cagliari
Country
Italy
Facility Name
Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"
City
Catania
Country
Italy
Facility Name
Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia
City
Catanzaro
Country
Italy
Facility Name
Sezione di Ematologia e Fisiopatologia delle Emostasi - Azienda Ospedaliera - Arcispedale S. Anna
City
Ferrara
Country
Italy
Facility Name
Divisione Ematologia 1 - Azienda Ospedaliera Universitaria "San Martino"
City
Genova
Country
Italy
Facility Name
Divisione di Ematologia Ospedale "Santa Maria Goretti"
City
Latina
Country
Italy
Facility Name
ST. V. Fazzi
City
Lecce
Country
Italy
Facility Name
A.O. Universitaria Policlinico Martina di Messina
City
Messina
Country
Italy
Facility Name
Azienda ospedaliera Papardo
City
Messina
Country
Italy
Facility Name
IRCCS Fondazione Centro S. Raffaele del Monte Tabor
City
Milano
Country
Italy
Facility Name
Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia
City
Milano
Country
Italy
Facility Name
UO Centro Trapianti di Midollo - IRCCS Ospedale Maggiore Policlinico
City
Milano
Country
Italy
Facility Name
Centro Oncologico Modenese - Dipartimento di Oncoematologia
City
Modena
Country
Italy
Facility Name
Azienda ospedaliera S. Gerardo di Monza
City
Monza
Country
Italy
Facility Name
A.S.L. Napoli 1 Ospedale San Giovanni Bosco
City
Napoli
Country
Italy
Facility Name
Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"
City
Napoli
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia
City
Napoli
Country
Italy
Facility Name
Servizio Sanitario Nazionale - Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli" - Struttura Complessa di Ematologia - Div. TERE- 4° piano - Padiglione Palermo
City
Napoli
Country
Italy
Facility Name
ASL SA/1 di Nocera Inferiore
City
Nocera Inferiore
Country
Italy
Facility Name
A.O. Universitaria S. Luigi Gonzaga di Orbassano
City
Orbassano
Country
Italy
Facility Name
Divisione di Ematologia con trapianto di midollo - A.U. Policlinico "Paolo Giaccone"
City
Palermo
Country
Italy
Facility Name
Ospedali Riuniti "Villa Sofia-Cervello"
City
Palermo
Country
Italy
Facility Name
Cattedra di Ematologia CTMO Università degli Studi di Parma
City
Parma
Country
Italy
Facility Name
IRCCS Policlinico S. Matteo di Pavia
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
Ematologia - Ospedale San Carlo
City
Potenza
Country
Italy
Facility Name
Ospedale S. Maria delle Croci di Ravenna
City
Ravenna
Country
Italy
Facility Name
Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"
City
Reggio Calabria
Country
Italy
Facility Name
IRCCS Centro di riferimento Oncologico di Basilicata
City
Rionero in Vulture
Country
Italy
Facility Name
Azienda Osp. S. Giovanni/Addolorata
City
Roma
Country
Italy
Facility Name
Divisione di Ematologia - Ospedale S. Camillo
City
Roma
Country
Italy
Facility Name
Ospedale S. Eugenio
City
Roma
Country
Italy
Facility Name
Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia
City
Roma
Country
Italy
Facility Name
Policlinico Campus Biomedico
City
Roma
Country
Italy
Facility Name
Policlinico Universitario Gemelli di Roma
City
Roma
Country
Italy
Facility Name
Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia
City
Roma
Country
Italy
Facility Name
Università degli Studi - Policlinico di Tor Vergata
City
Roma
Country
Italy
Facility Name
IRCCS Istituto Regina Elena
City
Rome
Country
Italy
Facility Name
Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
City
San Giovanni Rotondo
Country
Italy
Facility Name
Serv. di Ematologia Ist. di Ematologia ed Endocrinologia
City
Sassari
Country
Italy
Facility Name
U.O.C. Ematologia e Trapianti - A.O. Senese - Policlinico " Le Scotte"
City
Siena
Country
Italy
Facility Name
SCDO Ematologia 2 AOU S.Giovanni Battista
City
Torino
Country
Italy
Facility Name
Clinica Ematologica - Policlinico Universitario
City
Udine
Country
Italy
Facility Name
Ospedale di circolo e Fondazione Macchi
City
Varese
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
Facility Name
ULSS N.6 Osp. S. Bortolo
City
Vicenza
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
25245446
Citation
Efficace F, Mandelli F, Avvisati G, Cottone F, Ferrara F, Di Bona E, Specchia G, Breccia M, Levis A, Sica S, Finizio O, Kropp MG, Fioritoni G, Cerqui E, Vignetti M, Amadori S, Schlenk RF, Platzbecker U, Lo-Coco F. Randomized phase III trial of retinoic acid and arsenic trioxide versus retinoic acid and chemotherapy in patients with acute promyelocytic leukemia: health-related quality-of-life outcomes. J Clin Oncol. 2014 Oct 20;32(30):3406-12. doi: 10.1200/JCO.2014.55.3453. Epub 2014 Sep 22.
Results Reference
derived
PubMed Identifier
23841729
Citation
Lo-Coco F, Avvisati G, Vignetti M, Thiede C, Orlando SM, Iacobelli S, Ferrara F, Fazi P, Cicconi L, Di Bona E, Specchia G, Sica S, Divona M, Levis A, Fiedler W, Cerqui E, Breccia M, Fioritoni G, Salih HR, Cazzola M, Melillo L, Carella AM, Brandts CH, Morra E, von Lilienfeld-Toal M, Hertenstein B, Wattad M, Lubbert M, Hanel M, Schmitz N, Link H, Kropp MG, Rambaldi A, La Nasa G, Luppi M, Ciceri F, Finizio O, Venditti A, Fabbiano F, Dohner K, Sauer M, Ganser A, Amadori S, Mandelli F, Dohner H, Ehninger G, Schlenk RF, Platzbecker U; Gruppo Italiano Malattie Ematologiche dell'Adulto; German-Austrian Acute Myeloid Leukemia Study Group; Study Alliance Leukemia. Retinoic acid and arsenic trioxide for acute promyelocytic leukemia. N Engl J Med. 2013 Jul 11;369(2):111-21. doi: 10.1056/NEJMoa1300874.
Results Reference
derived
Links:
URL
http://www.gimema.it
Description
GIMEMA Foundation Website

Learn more about this trial

Phase III Trial in Acute Promyelocytic Leukemia Patients

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