Combination Chemotherapy Based on Risk of Relapse in Treating Young Patients With Acute Lymphoblastic Leukemia
NCT ID: NCT00430118
Last Updated: 2013-05-29
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
4559 participants
Study Classification
INTERVENTIONAL
Study Start Date
2000-07-31
Study Completion Date
2012-01-31
Brief Summary
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RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating young patients with acute lymphoblastic leukemia.
PURPOSE: Thisphase III trial is studying several different combination chemotherapy regimens to compare how well they work in treating young patients with acute lymphoblastic leukemia.
PURPOSE: Thisphase III trial is studying several different combination chemotherapy regimens to compare how well they work in treating young patients with acute lymphoblastic leukemia.
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Detailed Description
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OBJECTIVES:
* Compare the relative efficacy of induction therapy comprising dexamethasone or prednisone, in terms of a higher rate of event-free survival (EFS) and overall survival and a reduced rate of relapse, in pediatric patients with intermediate-risk or high-risk acute lymphoblastic leukemia (ALL).
* Compare the relative safety of a reduced-intensity reintensification regimen comprising dexamethasone, vincristine, cyclophosphamide, and anthracyclines vs a standard treatment regimen in pediatric patients with standard-risk ALL identified by fast clearance of leukemic cells.
* Compare the efficacy of a second delayed reintensification regimen vs standard reintensification therapy, in terms of improved EFS, in pediatric patients with intermediate-risk ALL.
* Compare the efficacy of extended reintensification therapy (triple reinduction) vs standard reintensification therapy (intensive pulses and one reintensification) in pediatric patients with high-risk ALL.
OUTLINE: This is a randomized, multicenter study.
* Prednisone prephase therapy: Patients receive oral prednisone on days 1-7 and one dose of methotrexate (MTX) intrathecally (IT) on day 1.
* Induction/consolidation therapy, protocol I: Patients are randomized to 1 of 2 treatment arms.
* Arm I (closed to accrual as of 6/30/2006): Patients receive prednisone (PRED) on days 8-28.
* Arm II (closed to accrual as of 6/30/2006): Patients receive dexamethasone (DEXA) on days 8-28.
Patients in both arms also receive vincristine (VCR) and daunorubicin hydrochloride (DNR) once weekly in weeks 2-5; asparaginase (ASP) on days 12-33; cyclophosphamide (CPM) on days 36 and 64; cytarabine (ARA-C) in weeks 6-9; mercaptopurine (MP) on days 36-63; and MTX IT on days 1, 12, 33, 45, and 59.\*
NOTE: \*Patients with CNS disease also receive MTX IT on days 18 and 27.
After completion of induction/consolidation therapy, patients are stratified according to risk group based on disease response (standard-risk \[SR\] group \[negative minimal residual disease (MRD) on day 33 and before protocol M, day 78\] vs high-risk \[HR\] group \[MRD ≥ 10\^-³ on day 78\] vs intermediate-risk \[IR\] group \[all nonSR/nonHR\]).\* Patients with SR and IR disease proceed to extracompartment therapy. Patients with HR disease proceed to reintensification therapy.
NOTE: \*Patients meeting any of the following criteria are placed in the HR group regardless of MRD response: Philadelphia chromosome-positive disease (BCR/ABL or t\[9;22\]; translocations \[t4;11\]\[q11;q23\] or MLL/AF4); "prednisone-poor-response" (≥ 1,000 blasts/mm³ in the peripheral blood on day 8 after prednisone prephase therapy); or no response to study induction therapy (M2/3 at day 33).
* Extracompartment therapy, protocol M: Patients receive MP on days 1-56 and MTX on days 8, 22, 36, and 50.
After completion of extracompartment therapy, SR and IR patients proceed to reintensification therapy. SR patients are randomized to arms I or II. IR patients are randomized to arms I or III. HR patients who have completed induction/consolidation therapy are randomized to arms IV or V.
* Reintensification therapy:
* Arm I (standard reinduction therapy, protocol II \[closed to accrual as of 6/30/2006\]): SR and IR patients receive DEXA on days 1-22; VCR and doxorubicin hydrochloride (DOX) in weeks 2-5; ASP on days 8, 11, 15, and 18; CPM on day 36; ARA-C and thioguanine (TG) on days 36-49; and MTX IT on days 38 and 45.\* Patients then proceed to maintenance therapy.
NOTE: \*Patients with CNS disease also receive MTX IT on days 1 and 18.
* Arm II (reduced-intensity reinduction therapy, protocol III \[closed to accrual as of 6/30/2006\]): SR patients receive DEXA on days 1-15; VCR and DOX on days 1 and 8; ASP on days 1, 4, 8, and 11; CPM on day 15; ARA-C and TG on days 15-28; and MTX IT on days 17 and 24.\* Patients then proceed to maintenance therapy.
NOTE: \*Patients with CNS disease also receive MTX on day 1.
* Arm III (reduced-intensity reinduction/second delayed reinduction therapy \[double reintensification therapy\] \[closed to accrual as of 6/30/2006\]): IR patients receive reduced-intensity reintensification therapy as in arm II. After a 10-week interim maintenance phase, treatment repeats once for a second delayed course of reintensification therapy. Patients then proceed to maintenance therapy.
* Arm IV (standard reintensification therapy \[closed to accrual as of 6/30/2006\]): HR patients receive two sequences of the following HR therapy elements (i.e., in this order: 1, 2, 3, 1, 2, 3) following reintensification therapy as in arm I. Patients then proceed to maintenance therapy.
* Element HR-1: Patients receive DEXA on days 1-5; VCR on days 1 and 6; ARA-C twice on day 5; MTX and CPM every 12 hours on days 2-4 (5 doses); ASP on days 6 and 11; and MTX/ARA-C/PRED IT on day 1.
* Element HR-2: Patients receive DEXA on days 1-5; vindesine on days 1 and 6; DNR on day 5; MTX and ifosfamide every 12 hours on days 2-4 (5 doses); ASP on days 6 and 11; and MTX/ARA-C/PRED IT on day 1.\* NOTE: \*HR patients with CNS disease also receive IT therapy on day 5.
* Element HR-3: Patients receive DEXA on days 1-5; ARA-C every 12 hours on days 1-2 (4 doses); etoposide five times daily on days 3-5; ASP on days 6 and 11; and MTX/ARA-C/PRED IT on day 1.
* Arm V (extended reintensification therapy \[triple protocol III\] \[closed to accrual as of 6/30/2006\]): HR patients receive HR therapy elements 3, 2, and 1 as in arm IV following reintensification therapy as in arm II repeated the therapy element twice with 4-week interim maintenance phases in between. Patients then proceed to maintenance therapy.
* Interim maintenance/maintenance therapy: Patients receive MTX once weekly and MP daily until week 104.
* Radiotherapy: HR patients or patients with T-cell acute lymphoblastic leukemia or CNS disease undergo CNS radiotherapy.
PROJECTED ACCRUAL: A total of 2,000 patients will be accrued for this study.
* Compare the relative efficacy of induction therapy comprising dexamethasone or prednisone, in terms of a higher rate of event-free survival (EFS) and overall survival and a reduced rate of relapse, in pediatric patients with intermediate-risk or high-risk acute lymphoblastic leukemia (ALL).
* Compare the relative safety of a reduced-intensity reintensification regimen comprising dexamethasone, vincristine, cyclophosphamide, and anthracyclines vs a standard treatment regimen in pediatric patients with standard-risk ALL identified by fast clearance of leukemic cells.
* Compare the efficacy of a second delayed reintensification regimen vs standard reintensification therapy, in terms of improved EFS, in pediatric patients with intermediate-risk ALL.
* Compare the efficacy of extended reintensification therapy (triple reinduction) vs standard reintensification therapy (intensive pulses and one reintensification) in pediatric patients with high-risk ALL.
OUTLINE: This is a randomized, multicenter study.
* Prednisone prephase therapy: Patients receive oral prednisone on days 1-7 and one dose of methotrexate (MTX) intrathecally (IT) on day 1.
* Induction/consolidation therapy, protocol I: Patients are randomized to 1 of 2 treatment arms.
* Arm I (closed to accrual as of 6/30/2006): Patients receive prednisone (PRED) on days 8-28.
* Arm II (closed to accrual as of 6/30/2006): Patients receive dexamethasone (DEXA) on days 8-28.
Patients in both arms also receive vincristine (VCR) and daunorubicin hydrochloride (DNR) once weekly in weeks 2-5; asparaginase (ASP) on days 12-33; cyclophosphamide (CPM) on days 36 and 64; cytarabine (ARA-C) in weeks 6-9; mercaptopurine (MP) on days 36-63; and MTX IT on days 1, 12, 33, 45, and 59.\*
NOTE: \*Patients with CNS disease also receive MTX IT on days 18 and 27.
After completion of induction/consolidation therapy, patients are stratified according to risk group based on disease response (standard-risk \[SR\] group \[negative minimal residual disease (MRD) on day 33 and before protocol M, day 78\] vs high-risk \[HR\] group \[MRD ≥ 10\^-³ on day 78\] vs intermediate-risk \[IR\] group \[all nonSR/nonHR\]).\* Patients with SR and IR disease proceed to extracompartment therapy. Patients with HR disease proceed to reintensification therapy.
NOTE: \*Patients meeting any of the following criteria are placed in the HR group regardless of MRD response: Philadelphia chromosome-positive disease (BCR/ABL or t\[9;22\]; translocations \[t4;11\]\[q11;q23\] or MLL/AF4); "prednisone-poor-response" (≥ 1,000 blasts/mm³ in the peripheral blood on day 8 after prednisone prephase therapy); or no response to study induction therapy (M2/3 at day 33).
* Extracompartment therapy, protocol M: Patients receive MP on days 1-56 and MTX on days 8, 22, 36, and 50.
After completion of extracompartment therapy, SR and IR patients proceed to reintensification therapy. SR patients are randomized to arms I or II. IR patients are randomized to arms I or III. HR patients who have completed induction/consolidation therapy are randomized to arms IV or V.
* Reintensification therapy:
* Arm I (standard reinduction therapy, protocol II \[closed to accrual as of 6/30/2006\]): SR and IR patients receive DEXA on days 1-22; VCR and doxorubicin hydrochloride (DOX) in weeks 2-5; ASP on days 8, 11, 15, and 18; CPM on day 36; ARA-C and thioguanine (TG) on days 36-49; and MTX IT on days 38 and 45.\* Patients then proceed to maintenance therapy.
NOTE: \*Patients with CNS disease also receive MTX IT on days 1 and 18.
* Arm II (reduced-intensity reinduction therapy, protocol III \[closed to accrual as of 6/30/2006\]): SR patients receive DEXA on days 1-15; VCR and DOX on days 1 and 8; ASP on days 1, 4, 8, and 11; CPM on day 15; ARA-C and TG on days 15-28; and MTX IT on days 17 and 24.\* Patients then proceed to maintenance therapy.
NOTE: \*Patients with CNS disease also receive MTX on day 1.
* Arm III (reduced-intensity reinduction/second delayed reinduction therapy \[double reintensification therapy\] \[closed to accrual as of 6/30/2006\]): IR patients receive reduced-intensity reintensification therapy as in arm II. After a 10-week interim maintenance phase, treatment repeats once for a second delayed course of reintensification therapy. Patients then proceed to maintenance therapy.
* Arm IV (standard reintensification therapy \[closed to accrual as of 6/30/2006\]): HR patients receive two sequences of the following HR therapy elements (i.e., in this order: 1, 2, 3, 1, 2, 3) following reintensification therapy as in arm I. Patients then proceed to maintenance therapy.
* Element HR-1: Patients receive DEXA on days 1-5; VCR on days 1 and 6; ARA-C twice on day 5; MTX and CPM every 12 hours on days 2-4 (5 doses); ASP on days 6 and 11; and MTX/ARA-C/PRED IT on day 1.
* Element HR-2: Patients receive DEXA on days 1-5; vindesine on days 1 and 6; DNR on day 5; MTX and ifosfamide every 12 hours on days 2-4 (5 doses); ASP on days 6 and 11; and MTX/ARA-C/PRED IT on day 1.\* NOTE: \*HR patients with CNS disease also receive IT therapy on day 5.
* Element HR-3: Patients receive DEXA on days 1-5; ARA-C every 12 hours on days 1-2 (4 doses); etoposide five times daily on days 3-5; ASP on days 6 and 11; and MTX/ARA-C/PRED IT on day 1.
* Arm V (extended reintensification therapy \[triple protocol III\] \[closed to accrual as of 6/30/2006\]): HR patients receive HR therapy elements 3, 2, and 1 as in arm IV following reintensification therapy as in arm II repeated the therapy element twice with 4-week interim maintenance phases in between. Patients then proceed to maintenance therapy.
* Interim maintenance/maintenance therapy: Patients receive MTX once weekly and MP daily until week 104.
* Radiotherapy: HR patients or patients with T-cell acute lymphoblastic leukemia or CNS disease undergo CNS radiotherapy.
PROJECTED ACCRUAL: A total of 2,000 patients will be accrued for this study.
Conditions
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Leukemia
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
FACTORIAL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Induction Prot I/Dexa - reinduction Prot III
Group Type
EXPERIMENTAL
asparaginase
Intervention Type
DRUG
cyclophosphamide
Intervention Type
DRUG
cytarabine
Intervention Type
DRUG
daunorubicin hydrochloride
Intervention Type
DRUG
dexamethasone
Intervention Type
DRUG
doxorubicin hydrochloride
Intervention Type
DRUG
ifosfamide
Intervention Type
DRUG
mercaptopurine
Intervention Type
DRUG
methotrexate
Intervention Type
DRUG
prednisone
Intervention Type
DRUG
thioguanine
Intervention Type
DRUG
vincristine sulfate
Intervention Type
DRUG
vindesine
Intervention Type
DRUG
radiation therapy
Intervention Type
RADIATION
Induction Prot I/Pred - reinduction Prot III
Group Type
EXPERIMENTAL
asparaginase
Intervention Type
DRUG
cyclophosphamide
Intervention Type
DRUG
cytarabine
Intervention Type
DRUG
daunorubicin hydrochloride
Intervention Type
DRUG
dexamethasone
Intervention Type
DRUG
doxorubicin hydrochloride
Intervention Type
DRUG
ifosfamide
Intervention Type
DRUG
mercaptopurine
Intervention Type
DRUG
methotrexate
Intervention Type
DRUG
prednisone
Intervention Type
DRUG
thioguanine
Intervention Type
DRUG
vincristine sulfate
Intervention Type
DRUG
vindesine
Intervention Type
DRUG
radiation therapy
Intervention Type
RADIATION
Induction Prot I/Dexa - reinduction Prot II
Group Type
EXPERIMENTAL
asparaginase
Intervention Type
DRUG
cyclophosphamide
Intervention Type
DRUG
cytarabine
Intervention Type
DRUG
daunorubicin hydrochloride
Intervention Type
DRUG
dexamethasone
Intervention Type
DRUG
doxorubicin hydrochloride
Intervention Type
DRUG
ifosfamide
Intervention Type
DRUG
mercaptopurine
Intervention Type
DRUG
methotrexate
Intervention Type
DRUG
prednisone
Intervention Type
DRUG
thioguanine
Intervention Type
DRUG
vincristine sulfate
Intervention Type
DRUG
vindesine
Intervention Type
DRUG
radiation therapy
Intervention Type
RADIATION
Induction Prot I/Pred - reinduction Prot II
Group Type
ACTIVE_COMPARATOR
asparaginase
Intervention Type
DRUG
cyclophosphamide
Intervention Type
DRUG
cytarabine
Intervention Type
DRUG
daunorubicin hydrochloride
Intervention Type
DRUG
dexamethasone
Intervention Type
DRUG
doxorubicin hydrochloride
Intervention Type
DRUG
ifosfamide
Intervention Type
DRUG
mercaptopurine
Intervention Type
DRUG
methotrexate
Intervention Type
DRUG
prednisone
Intervention Type
DRUG
thioguanine
Intervention Type
DRUG
vincristine sulfate
Intervention Type
DRUG
vindesine
Intervention Type
DRUG
radiation therapy
Intervention Type
RADIATION
Induction Prot I/Dexa - reinduction 2x Prot III
Group Type
EXPERIMENTAL
asparaginase
Intervention Type
DRUG
cyclophosphamide
Intervention Type
DRUG
cytarabine
Intervention Type
DRUG
daunorubicin hydrochloride
Intervention Type
DRUG
dexamethasone
Intervention Type
DRUG
doxorubicin hydrochloride
Intervention Type
DRUG
ifosfamide
Intervention Type
DRUG
mercaptopurine
Intervention Type
DRUG
methotrexate
Intervention Type
DRUG
prednisone
Intervention Type
DRUG
thioguanine
Intervention Type
DRUG
vincristine sulfate
Intervention Type
DRUG
vindesine
Intervention Type
DRUG
radiation therapy
Intervention Type
RADIATION
Induction Prot I/Pred - reinduction 2x Prot III
Group Type
EXPERIMENTAL
asparaginase
Intervention Type
DRUG
cyclophosphamide
Intervention Type
DRUG
cytarabine
Intervention Type
DRUG
daunorubicin hydrochloride
Intervention Type
DRUG
dexamethasone
Intervention Type
DRUG
doxorubicin hydrochloride
Intervention Type
DRUG
ifosfamide
Intervention Type
DRUG
mercaptopurine
Intervention Type
DRUG
methotrexate
Intervention Type
DRUG
prednisone
Intervention Type
DRUG
thioguanine
Intervention Type
DRUG
vincristine sulfate
Intervention Type
DRUG
vindesine
Intervention Type
DRUG
radiation therapy
Intervention Type
RADIATION
Induction Prot I/Dexa - reinduction 3 HR courses + 3x Prot III
Group Type
EXPERIMENTAL
asparaginase
Intervention Type
DRUG
cyclophosphamide
Intervention Type
DRUG
cytarabine
Intervention Type
DRUG
daunorubicin hydrochloride
Intervention Type
DRUG
dexamethasone
Intervention Type
DRUG
doxorubicin hydrochloride
Intervention Type
DRUG
etoposide
Intervention Type
DRUG
ifosfamide
Intervention Type
DRUG
mercaptopurine
Intervention Type
DRUG
methotrexate
Intervention Type
DRUG
prednisone
Intervention Type
DRUG
thioguanine
Intervention Type
DRUG
vincristine sulfate
Intervention Type
DRUG
vindesine
Intervention Type
DRUG
radiation therapy
Intervention Type
RADIATION
Induction Prot I/Pred - reinduction 3 HR courses + 3x Prot III
Group Type
EXPERIMENTAL
asparaginase
Intervention Type
DRUG
cyclophosphamide
Intervention Type
DRUG
cytarabine
Intervention Type
DRUG
daunorubicin hydrochloride
Intervention Type
DRUG
dexamethasone
Intervention Type
DRUG
doxorubicin hydrochloride
Intervention Type
DRUG
etoposide
Intervention Type
DRUG
ifosfamide
Intervention Type
DRUG
mercaptopurine
Intervention Type
DRUG
methotrexate
Intervention Type
DRUG
prednisone
Intervention Type
DRUG
thioguanine
Intervention Type
DRUG
vincristine sulfate
Intervention Type
DRUG
vindesine
Intervention Type
DRUG
radiation therapy
Intervention Type
RADIATION
Induction Prot I/Dexa - reinduction 6 HR courses + Prot II
Group Type
EXPERIMENTAL
asparaginase
Intervention Type
DRUG
cyclophosphamide
Intervention Type
DRUG
cytarabine
Intervention Type
DRUG
daunorubicin hydrochloride
Intervention Type
DRUG
dexamethasone
Intervention Type
DRUG
doxorubicin hydrochloride
Intervention Type
DRUG
etoposide
Intervention Type
DRUG
ifosfamide
Intervention Type
DRUG
mercaptopurine
Intervention Type
DRUG
methotrexate
Intervention Type
DRUG
prednisone
Intervention Type
DRUG
thioguanine
Intervention Type
DRUG
vincristine sulfate
Intervention Type
DRUG
vindesine
Intervention Type
DRUG
radiation therapy
Intervention Type
RADIATION
Induction Prot I/Pred - reinduction 6 HR courses + Prot II
Group Type
ACTIVE_COMPARATOR
asparaginase
Intervention Type
DRUG
cyclophosphamide
Intervention Type
DRUG
cytarabine
Intervention Type
DRUG
daunorubicin hydrochloride
Intervention Type
DRUG
dexamethasone
Intervention Type
DRUG
doxorubicin hydrochloride
Intervention Type
DRUG
etoposide
Intervention Type
DRUG
ifosfamide
Intervention Type
DRUG
mercaptopurine
Intervention Type
DRUG
methotrexate
Intervention Type
DRUG
prednisone
Intervention Type
DRUG
thioguanine
Intervention Type
DRUG
vincristine sulfate
Intervention Type
DRUG
vindesine
Intervention Type
DRUG
radiation therapy
Intervention Type
RADIATION
Interventions
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asparaginase
Intervention Type
DRUG
cyclophosphamide
Intervention Type
DRUG
cytarabine
Intervention Type
DRUG
daunorubicin hydrochloride
Intervention Type
DRUG
dexamethasone
Intervention Type
DRUG
doxorubicin hydrochloride
Intervention Type
DRUG
etoposide
Intervention Type
DRUG
ifosfamide
Intervention Type
DRUG
mercaptopurine
Intervention Type
DRUG
methotrexate
Intervention Type
DRUG
prednisone
Intervention Type
DRUG
thioguanine
Intervention Type
DRUG
vincristine sulfate
Intervention Type
DRUG
vindesine
Intervention Type
DRUG
radiation therapy
Intervention Type
RADIATION
Eligibility Criteria
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Inclusion Criteria
DISEASE CHARACTERISTICS:
* Histologically confirmed acute lymphoblastic leukemia (ALL)
* No secondary ALL
PATIENT CHARACTERISTICS:
* No prior disease that would preclude treatment with chemotherapy
PRIOR CONCURRENT THERAPY:
* More than 4 weeks since prior chemotherapy
* More than 4 weeks since prior steroids
* Histologically confirmed acute lymphoblastic leukemia (ALL)
* No secondary ALL
PATIENT CHARACTERISTICS:
* No prior disease that would preclude treatment with chemotherapy
PRIOR CONCURRENT THERAPY:
* More than 4 weeks since prior chemotherapy
* More than 4 weeks since prior steroids
Minimum Eligible Age
1 Year
Maximum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University Hospital Schleswig-Holstein
OTHER
Sponsor Role
lead
Responsible Party
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Martin Schrappe
Prof. Dr. med.
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Martin Schrappe, MD, PhD
Role: STUDY_CHAIR
University Hospital Schleswig-Holstein
Locations
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Krankenhaus Dornbirn
Dornbirn, , Austria
Site Status
Landeskrankenhaus Feldkirch
Feldkirch-Tisis, , Austria
Site Status
Universitaet Kinderklinik
Graz, , Austria
Site Status
Innsbruck Universitaetsklinik
Innsbruck, , Austria
Site Status
Landeskrankenhaus Klagenfurt
Klagenfurt, , Austria
Site Status
LKH Leoben
Leoben, , Austria
Site Status
A. oe. Krankenhaus der Barmherzigen Schwestern Kinderabteilung
Linz, , Austria
Site Status
Landes-Kinderkrankenhaus
Linz, , Austria
Site Status
St. Johanns-Spital
Salzburg, , Austria
Site Status
St. Anna Children's Hospital
Vienna, , Austria
Site Status
Kinderklinik - Universitaetsklinikum Aachen
Aachen, , Germany
Site Status
Klinikum Augsburg
Augsburg, , Germany
Site Status
Caritas-Krankenhaus Bad Mergentheim
Bad Mergentheim, , Germany
Site Status
Klinikum Bayreuth
Bayreuth, , Germany
Site Status
Helios Klinikum Berlin
Berlin, , Germany
Site Status
Charite University Hospital - Campus Virchow Klinikum
Berlin, , Germany
Site Status
Kinderklinik der Universitaet Bonn
Bonn, , Germany
Site Status
Staedtisches Klinikum - Howedestrase
Braunschweig, , Germany
Site Status
Klinikum Chemnitz gGmbH
Chemnitz, , Germany
Site Status
Klinikum Coburg
Coburg, , Germany
Site Status
Kliniken der Stadt Koeln gGmbH - Kinderkrankenhaus Riehl
Cologne, , Germany
Site Status
Children's Hospital
Cologne, , Germany
Site Status
Carl - Thiem - Klinkum Cottbus
Cottbus, , Germany
Site Status
Vestische Kinderklinik Universitaetsklinik Witten/Herdecke
Datteln, , Germany
Site Status
Klinikum Lippe - Detmold
Detmold, , Germany
Site Status
Klinikum Dortmund
Dortmund, , Germany
Site Status
Universitatsklinikum Carl Gustav Carus
Dresden, , Germany
Site Status
Klinikum Duisburg
Duisburg, , Germany
Site Status
Helios Klinikum Erfurt
Erfurt, , Germany
Site Status
Universitaets - Kinderklinik
Erlangen, , Germany
Site Status
Universitaetsklinikum Essen
Essen, , Germany
Site Status
Klinikum der J.W. Goethe Universitaet
Frankfurt, , Germany
Site Status
Universitaetskinderklinik - Universitaetsklinikum Freiburg
Freiburg im Breisgau, , Germany
Site Status
Kinderklinik
Giessen, , Germany
Site Status
Universitaetsklinikum Goettingen
Göttingen, , Germany
Site Status
Universitaetsklinikum Halle
Halle, , Germany
Site Status
Medizinische Hochschule Hannover
Hanover, , Germany
Site Status
Universitaets-Kinderklinik Heidelberg
Heidelberg, , Germany
Site Status
SLK - Kliniken Heilbronn GmbH - Klinikum am Gesundbrunnen
Heilbronn, , Germany
Site Status
Gemeinschaftskrankenhaus
Herdecke, , Germany
Site Status
Universitaetsklinikum des Saarlandes
Homburg, , Germany
Site Status
Universitaets - Kinderklinik
Jena, , Germany
Site Status
Staedtisches Klinikum Karlsruhe gGmbH
Karlsruhe, , Germany
Site Status
Klinikum Kassel
Kassel, , Germany
Site Status
University Hospital Schleswig-Holstein - Kiel Campus
Kiel, , Germany
Site Status
Klinikum Kemperhof Koblenz
Koblenz, , Germany
Site Status
St. Annastift Krankenhaus
Ludwigshafen, , Germany
Site Status
Universitaets - Kinderklinik - Luebeck
Lübeck, , Germany
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Universitatsklinikum der MA
Magdeburg, , Germany
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Staedtisches Klinik - Kinderklinik
Mannheim, , Germany
Site Status
Universitaetsklinikum Giessen und Marburg GmbH - Marburg
Marburg, , Germany
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Klinikum Minden
Minden, , Germany
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Krankenhaus Muenchen Schwabing
Munich, , Germany
Site Status
Klinik und Poliklinik fuer Kinder und Jugendmedizin - Universitaetsklinikum Muenster
Münster, , Germany
Site Status
Kinderklinik Kohlhof
Neunkirchen, , Germany
Site Status
Cnopf'sche Kinderklinik
Nuremberg, , Germany
Site Status
Klinikum Oldenburg
Oldenburg, , Germany
Site Status
Kinderklinik - Universitaetsklinikum Rostock
Rostock, , Germany
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Saarbrucker Winterbergkliniken
Saarbrücken, , Germany
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Johanniter-Kinderklinik
Sankt Augustin, , Germany
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Klinikum Schwerin
Schwerin, , Germany
Site Status
Kinderklink Siegen Deutsches Rotes Kreuz
Siegen, , Germany
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Olgahospital
Stuttgart, , Germany
Site Status
Krankenanstalt Mutterhaus der Borromaerinnen
Trier, , Germany
Site Status
Universitaetsklinikum Tuebingen
Tübingen, , Germany
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Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
Ulm, , Germany
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St. Marienhospital - Vechta
Vechta, , Germany
Site Status
Reinhard-Nieter-Krankenhaus
Wilhelmshaven, , Germany
Site Status
Klinikum der Stadt Wolfsburg
Wolfsburg, , Germany
Site Status
Universitaets - Kinderklinik Wuerzburg
Würzburg, , Germany
Site Status
Kantonsspital Aarau
Aarau, , Switzerland
Site Status
Universitaets-Kinderspital beider Basel
Basel, , Switzerland
Site Status
Ospedale "la Carita", Locarno
Locarno, , Switzerland
Site Status
Kinderspital Luzern
Lucerne, , Switzerland
Site Status
Ostschweizer Kinderspital
Sankt Gallen, , Switzerland
Site Status
University Children's Hospital
Zurich, , Switzerland
Site Status
Countries
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Austria
Germany
Switzerland
References
Explore related publications, articles, or registry entries linked to this study.
Attarbaschi A, Mann G, Panzer-Grumayer R, Rottgers S, Steiner M, Konig M, Csinady E, Dworzak MN, Seidel M, Janousek D, Moricke A, Reichelt C, Harbott J, Schrappe M, Gadner H, Haas OA. Minimal residual disease values discriminate between low and high relapse risk in children with B-cell precursor acute lymphoblastic leukemia and an intrachromosomal amplification of chromosome 21: the Austrian and German acute lymphoblastic leukemia Berlin-Frankfurt-Munster (ALL-BFM) trials. J Clin Oncol. 2008 Jun 20;26(18):3046-50. doi: 10.1200/JCO.2008.16.1117.
Reference Type
BACKGROUND
Schrappe M, Valsecchi MG, Bartram CR, Schrauder A, Panzer-Grumayer R, Moricke A, Parasole R, Zimmermann M, Dworzak M, Buldini B, Reiter A, Basso G, Klingebiel T, Messina C, Ratei R, Cazzaniga G, Koehler R, Locatelli F, Schafer BW, Arico M, Welte K, van Dongen JJ, Gadner H, Biondi A, Conter V. Late MRD response determines relapse risk overall and in subsets of childhood T-cell ALL: results of the AIEOP-BFM-ALL 2000 study. Blood. 2011 Aug 25;118(8):2077-84. doi: 10.1182/blood-2011-03-338707. Epub 2011 Jun 30.
Reference Type
RESULT
Conter V, Bartram CR, Valsecchi MG, Schrauder A, Panzer-Grumayer R, Moricke A, Arico M, Zimmermann M, Mann G, De Rossi G, Stanulla M, Locatelli F, Basso G, Niggli F, Barisone E, Henze G, Ludwig WD, Haas OA, Cazzaniga G, Koehler R, Silvestri D, Bradtke J, Parasole R, Beier R, van Dongen JJ, Biondi A, Schrappe M. Molecular response to treatment redefines all prognostic factors in children and adolescents with B-cell precursor acute lymphoblastic leukemia: results in 3184 patients of the AIEOP-BFM ALL 2000 study. Blood. 2010 Apr 22;115(16):3206-14. doi: 10.1182/blood-2009-10-248146. Epub 2010 Feb 12.
Reference Type
RESULT
Kox C, Zimmermann M, Stanulla M, Leible S, Schrappe M, Ludwig WD, Koehler R, Tolle G, Bandapalli OR, Breit S, Muckenthaler MU, Kulozik AE. The favorable effect of activating NOTCH1 receptor mutations on long-term outcome in T-ALL patients treated on the ALL-BFM 2000 protocol can be separated from FBXW7 loss of function. Leukemia. 2010 Dec;24(12):2005-13. doi: 10.1038/leu.2010.203. Epub 2010 Oct 14.
Reference Type
RESULT
Schrey D, Borghorst S, Lanvers-Kaminsky C, Hempel G, Gerss J, Moricke A, Schrappe M, Boos J. Therapeutic drug monitoring of asparaginase in the ALL-BFM 2000 protocol between 2000 and 2007. Pediatr Blood Cancer. 2010 Jul 1;54(7):952-8. doi: 10.1002/pbc.22417.
Reference Type
RESULT
Dworzak MN, Schumich A, Printz D, Potschger U, Husak Z, Attarbaschi A, Basso G, Gaipa G, Ratei R, Mann G, Gadner H. CD20 up-regulation in pediatric B-cell precursor acute lymphoblastic leukemia during induction treatment: setting the stage for anti-CD20 directed immunotherapy. Blood. 2008 Nov 15;112(10):3982-8. doi: 10.1182/blood-2008-06-164129. Epub 2008 Sep 9.
Reference Type
RESULT
Flohr T, Schrauder A, Cazzaniga G, Panzer-Grumayer R, van der Velden V, Fischer S, Stanulla M, Basso G, Niggli FK, Schafer BW, Sutton R, Koehler R, Zimmermann M, Valsecchi MG, Gadner H, Masera G, Schrappe M, van Dongen JJ, Biondi A, Bartram CR; International BFM Study Group (I-BFM-SG). Minimal residual disease-directed risk stratification using real-time quantitative PCR analysis of immunoglobulin and T-cell receptor gene rearrangements in the international multicenter trial AIEOP-BFM ALL 2000 for childhood acute lymphoblastic leukemia. Leukemia. 2008 Apr;22(4):771-82. doi: 10.1038/leu.2008.5. Epub 2008 Jan 31.
Reference Type
RESULT
Junk SV, Schaeffeler E, Zimmermann M, Moricke A, Beier R, Schutte P, Fedders B, Alten J, Hinze L, Klein N, Kulozik A, Muckenthaler MU, Koehler R, Borkhardt A, Vijayakrishnan J, Ellinghaus D, Forster M, Franke A, Wintering A, Kratz CP, Schrappe M, Schwab M, Houlston RS, Cario G, Stanulla M. Chemotherapy-related hyperbilirubinemia in pediatric acute lymphoblastic leukemia: a genome-wide association study from the AIEOP-BFM ALL study group. J Exp Clin Cancer Res. 2023 Jan 13;42(1):21. doi: 10.1186/s13046-022-02585-x.
Reference Type
DERIVED
Stanulla M, Dagdan E, Zaliova M, Moricke A, Palmi C, Cazzaniga G, Eckert C, Te Kronnie G, Bourquin JP, Bornhauser B, Koehler R, Bartram CR, Ludwig WD, Bleckmann K, Groeneveld-Krentz S, Schewe D, Junk SV, Hinze L, Klein N, Kratz CP, Biondi A, Borkhardt A, Kulozik A, Muckenthaler MU, Basso G, Valsecchi MG, Izraeli S, Petersen BS, Franke A, Dorge P, Steinemann D, Haas OA, Panzer-Grumayer R, Cave H, Houlston RS, Cario G, Schrappe M, Zimmermann M; TRANSCALL Consortium; International BFM Study Group. IKZF1plus Defines a New Minimal Residual Disease-Dependent Very-Poor Prognostic Profile in Pediatric B-Cell Precursor Acute Lymphoblastic Leukemia. J Clin Oncol. 2018 Apr 20;36(12):1240-1249. doi: 10.1200/JCO.2017.74.3617. Epub 2018 Mar 2.
Reference Type
DERIVED
Schrappe M, Bleckmann K, Zimmermann M, Biondi A, Moricke A, Locatelli F, Cario G, Rizzari C, Attarbaschi A, Valsecchi MG, Bartram CR, Barisone E, Niggli F, Niemeyer C, Testi AM, Mann G, Ziino O, Schafer B, Panzer-Grumayer R, Beier R, Parasole R, Gohring G, Ludwig WD, Casale F, Schlegel PG, Basso G, Conter V. Reduced-Intensity Delayed Intensification in Standard-Risk Pediatric Acute Lymphoblastic Leukemia Defined by Undetectable Minimal Residual Disease: Results of an International Randomized Trial (AIEOP-BFM ALL 2000). J Clin Oncol. 2018 Jan 20;36(3):244-253. doi: 10.1200/JCO.2017.74.4946. Epub 2017 Nov 17.
Reference Type
DERIVED
Zuna J, Moericke A, Arens M, Koehler R, Panzer-Grumayer R, Bartram CR, Fischer S, Fronkova E, Zaliova M, Schrauder A, Stanulla M, Zimmermann M, Trka J, Stary J, Attarbaschi A, Mann G, Schrappe M, Cario G. Implications of delayed bone marrow aspirations at the end of treatment induction for risk stratification and outcome in children with acute lymphoblastic leukaemia. Br J Haematol. 2016 Jun;173(5):742-8. doi: 10.1111/bjh.13989. Epub 2016 Feb 23.
Reference Type
DERIVED
Moricke A, Zimmermann M, Valsecchi MG, Stanulla M, Biondi A, Mann G, Locatelli F, Cazzaniga G, Niggli F, Arico M, Bartram CR, Attarbaschi A, Silvestri D, Beier R, Basso G, Ratei R, Kulozik AE, Lo Nigro L, Kremens B, Greiner J, Parasole R, Harbott J, Caruso R, von Stackelberg A, Barisone E, Rossig C, Conter V, Schrappe M. Dexamethasone vs prednisone in induction treatment of pediatric ALL: results of the randomized trial AIEOP-BFM ALL 2000. Blood. 2016 Apr 28;127(17):2101-12. doi: 10.1182/blood-2015-09-670729. Epub 2016 Feb 17.
Reference Type
DERIVED
Cario G, Rhein P, Mitlohner R, Zimmermann M, Bandapalli OR, Romey R, Moericke A, Ludwig WD, Ratei R, Muckenthaler MU, Kulozik AE, Schrappe M, Stanulla M, Karawajew L. High CD45 surface expression determines relapse risk in children with precursor B-cell and T-cell acute lymphoblastic leukemia treated according to the ALL-BFM 2000 protocol. Haematologica. 2014 Jan;99(1):103-10. doi: 10.3324/haematol.2013.090225. Epub 2013 Aug 2.
Reference Type
DERIVED
Dorge P, Meissner B, Zimmermann M, Moricke A, Schrauder A, Bouquin JP, Schewe D, Harbott J, Teigler-Schlegel A, Ratei R, Ludwig WD, Koehler R, Bartram CR, Schrappe M, Stanulla M, Cario G. IKZF1 deletion is an independent predictor of outcome in pediatric acute lymphoblastic leukemia treated according to the ALL-BFM 2000 protocol. Haematologica. 2013 Mar;98(3):428-32. doi: 10.3324/haematol.2011.056135. Epub 2012 Aug 8.
Reference Type
DERIVED
Zeidler L, Zimmermann M, Moricke A, Meissner B, Bartels D, Tschan C, Schrauder A, Cario G, Goudeva L, Jager S, Ratei R, Ludwig WD, Teigler-Schlegel A, Skokowa J, Koehler R, Bartram CR, Riehm H, Schrappe M, Welte K, Stanulla M. Low platelet counts after induction therapy for childhood acute lymphoblastic leukemia are strongly associated with poor early response to treatment as measured by minimal residual disease and are prognostic for treatment outcome. Haematologica. 2012 Mar;97(3):402-9. doi: 10.3324/haematol.2011.045229. Epub 2011 Nov 4.
Reference Type
DERIVED
Willer A, Gerss J, Konig T, Franke D, Kuhnel HJ, Henze G, von Stackelberg A, Moricke A, Schrappe M, Boos J, Lanvers-Kaminsky C. Anti-Escherichia coli asparaginase antibody levels determine the activity of second-line treatment with pegylated E coli asparaginase: a retrospective analysis within the ALL-BFM trials. Blood. 2011 Nov 24;118(22):5774-82. doi: 10.1182/blood-2011-07-367904. Epub 2011 Sep 22.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ALL-BFM-2000
Identifier Type: -
Identifier Source: secondary_id
EU-20682
Identifier Type: -
Identifier Source: secondary_id
CDR0000528029
Identifier Type: -
Identifier Source: org_study_id
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