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Combination Chemotherapy Based on Risk of Relapse in Treating Young Patients With Acute Lymphoblastic Leukemia

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ClinicalTrials.gov Identifier: NCT00430118
Recruitment Status : Completed
First Posted : February 1, 2007
Last Update Posted : May 29, 2013
Sponsor:
Information provided by (Responsible Party):
Martin Schrappe, University of Schleswig-Holstein

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Leukemia Drug: asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: etoposide Drug: ifosfamide Drug: mercaptopurine Drug: methotrexate Drug: prednisone Drug: thioguanine Drug: vincristine sulfate Drug: vindesine Radiation: radiation therapy Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4559 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ALL-BFM 2000 Multi-Center Study for the Treatment of Children and Adolescents With Acute Lymphoblastic Leukemia
Study Start Date : July 2000
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012


Arm Intervention/treatment
Experimental: Induction Prot I/Dexa - reinduction Prot III Drug: asparaginase
Drug: cyclophosphamide
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: dexamethasone
Drug: doxorubicin hydrochloride
Drug: ifosfamide
Drug: mercaptopurine
Drug: methotrexate
Drug: prednisone
Drug: thioguanine
Drug: vincristine sulfate
Drug: vindesine
Radiation: radiation therapy
Experimental: Induction Prot I/Pred - reinduction Prot III Drug: asparaginase
Drug: cyclophosphamide
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: dexamethasone
Drug: doxorubicin hydrochloride
Drug: ifosfamide
Drug: mercaptopurine
Drug: methotrexate
Drug: prednisone
Drug: thioguanine
Drug: vincristine sulfate
Drug: vindesine
Radiation: radiation therapy
Experimental: Induction Prot I/Dexa - reinduction Prot II Drug: asparaginase
Drug: cyclophosphamide
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: dexamethasone
Drug: doxorubicin hydrochloride
Drug: ifosfamide
Drug: mercaptopurine
Drug: methotrexate
Drug: prednisone
Drug: thioguanine
Drug: vincristine sulfate
Drug: vindesine
Radiation: radiation therapy
Active Comparator: Induction Prot I/Pred - reinduction Prot II Drug: asparaginase
Drug: cyclophosphamide
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: dexamethasone
Drug: doxorubicin hydrochloride
Drug: ifosfamide
Drug: mercaptopurine
Drug: methotrexate
Drug: prednisone
Drug: thioguanine
Drug: vincristine sulfate
Drug: vindesine
Radiation: radiation therapy
Experimental: Induction Prot I/Dexa - reinduction 2x Prot III Drug: asparaginase
Drug: cyclophosphamide
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: dexamethasone
Drug: doxorubicin hydrochloride
Drug: ifosfamide
Drug: mercaptopurine
Drug: methotrexate
Drug: prednisone
Drug: thioguanine
Drug: vincristine sulfate
Drug: vindesine
Radiation: radiation therapy
Experimental: Induction Prot I/Pred - reinduction 2x Prot III Drug: asparaginase
Drug: cyclophosphamide
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: dexamethasone
Drug: doxorubicin hydrochloride
Drug: ifosfamide
Drug: mercaptopurine
Drug: methotrexate
Drug: prednisone
Drug: thioguanine
Drug: vincristine sulfate
Drug: vindesine
Radiation: radiation therapy
Experimental: Induction Prot I/Dexa - reinduction 3 HR courses + 3x Prot III Drug: asparaginase
Drug: cyclophosphamide
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: dexamethasone
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: ifosfamide
Drug: mercaptopurine
Drug: methotrexate
Drug: prednisone
Drug: thioguanine
Drug: vincristine sulfate
Drug: vindesine
Radiation: radiation therapy
Experimental: Induction Prot I/Pred - reinduction 3 HR courses + 3x Prot III Drug: asparaginase
Drug: cyclophosphamide
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: dexamethasone
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: ifosfamide
Drug: mercaptopurine
Drug: methotrexate
Drug: prednisone
Drug: thioguanine
Drug: vincristine sulfate
Drug: vindesine
Radiation: radiation therapy
Experimental: Induction Prot I/Dexa - reinduction 6 HR courses + Prot II Drug: asparaginase
Drug: cyclophosphamide
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: dexamethasone
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: ifosfamide
Drug: mercaptopurine
Drug: methotrexate
Drug: prednisone
Drug: thioguanine
Drug: vincristine sulfate
Drug: vindesine
Radiation: radiation therapy
Active Comparator: Induction Prot I/Pred - reinduction 6 HR courses + Prot II Drug: asparaginase
Drug: cyclophosphamide
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: dexamethasone
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: ifosfamide
Drug: mercaptopurine
Drug: methotrexate
Drug: prednisone
Drug: thioguanine
Drug: vincristine sulfate
Drug: vindesine
Radiation: radiation therapy



Primary Outcome Measures :
  1. Efficacy of dexamethasone vs prednisone during the induction phase [ Time Frame: End of Trial ]
  2. Event-free survival (EFS) and overall survival after initial remission in intermediate-risk and high-risk patients [ Time Frame: End of Trial ]
  3. Safety and efficacy of treatment reduction during reintensification in standard-risk patients [ Time Frame: End of Trial ]
  4. EFS after second delayed reintensification in intermediate-risk patients [ Time Frame: End of Trial ]
  5. Outcome after extended reintensification therapy in high-risk patients [ Time Frame: End of Trial ]


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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00430118


  Show 76 Study Locations
Sponsors and Collaborators
University of Schleswig-Holstein
Investigators
Study Chair: Martin Schrappe, MD, PhD University of Schleswig-Holstein

Publications of Results:

Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Martin Schrappe, Prof. Dr. med., University of Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT00430118     History of Changes
Other Study ID Numbers: CDR0000528029
ALL-BFM-2000
EU-20682
First Posted: February 1, 2007    Key Record Dates
Last Update Posted: May 29, 2013
Last Verified: May 2013

Keywords provided by Martin Schrappe, University of Schleswig-Holstein:
T-cell childhood acute lymphoblastic leukemia
recurrent childhood acute lymphoblastic leukemia
untreated childhood acute lymphoblastic leukemia
B-cell childhood acute lymphoblastic leukemia

Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
Prednisone
Liposomal doxorubicin
Cyclophosphamide
Doxorubicin
Methotrexate
Etoposide
Cytarabine
Vincristine
Ifosfamide
Daunorubicin
Asparaginase
6-Mercaptopurine
Thioguanine
Vindesine
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents