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
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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.
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 |

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 |
- Efficacy of dexamethasone vs prednisone during the induction phase [ Time Frame: End of Trial ]
- Event-free survival (EFS) and overall survival after initial remission in intermediate-risk and high-risk patients [ Time Frame: End of Trial ]
- Safety and efficacy of treatment reduction during reintensification in standard-risk patients [ Time Frame: End of Trial ]
- EFS after second delayed reintensification in intermediate-risk patients [ Time Frame: End of Trial ]
- 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 |
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

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

Study Chair: | Martin Schrappe, MD, PhD | University Hospital Schleswig-Holstein |
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Martin Schrappe, Prof. Dr. med., University Hospital Schleswig-Holstein |
ClinicalTrials.gov Identifier: | NCT00430118 |
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 |
T-cell childhood acute lymphoblastic leukemia recurrent childhood acute lymphoblastic leukemia untreated childhood acute lymphoblastic leukemia B-cell childhood acute lymphoblastic leukemia |
Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cytarabine Dexamethasone Prednisone Cyclophosphamide Ifosfamide Doxorubicin |
Liposomal doxorubicin Methotrexate Etoposide Vincristine Daunorubicin Asparaginase Mercaptopurine Thioguanine Vindesine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents |