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| Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00022737 |
Purpose
RATIONALE: Giving combination chemotherapy before a donor peripheral stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.
PURPOSE: This phase II trial is studying how well combination chemotherapy with or without donor peripheral stem cell transplant works in treating children with acute lymphoblastic leukemia.
| Condition | Intervention | Phase |
|
Leukemia |
Drug: asparaginase Drug: cyclophosphamide Drug: cyclosporine Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: etoposide Drug: filgrastim Drug: ifosfamide Drug: imatinib mesylate Drug: leucovorin calcium Drug: mercaptopurine Drug: methotrexate Drug: pegaspargase Drug: vincristine sulfate Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation Procedure: radiation therapy Procedure: umbilical cord blood transplantation |
Phase II |
| MedlinePlus related topics: | Bone Marrow Transplantation Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Children's Oncology Group Pilot Study for the Treatment of Very High Risk Acute Lymphoblastic Leukemia in Children and Adolescents (STI571 NSC#716051/IND#55666) |
| Estimated Enrollment: | 220 |
| Study Start Date: | October 2002 |
| Estimated Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
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Show Detailed Description |
Eligibility
| Ages Eligible for Study: | 1 Year to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
M1 or M2 bone marrow status after front-line induction therapy and presenting with at least 1 of the following:
Failed to achieve remission after front-line induction therapy
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations![]() |
Show 154 Study Locations |
| Children's Oncology Group |
| National Cancer Institute (NCI) |
| Study Chair: | Kirk R. Schultz, MD | Children's & Women's Hospital of British Columbia |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Schultz KR, Aledo A, Bowman WP, et al.: Minimal toxicity of imatinib mesylate in combination with intensive chemotherapy for Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL) in children: a report of the Childrens Oncology Group (COG) AALL0031 protocol for very high risk ALL. [Abstract] Blood 108 (11): A-283, 2006.
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| Study ID Numbers: | CDR0000068859, COG-AALL0031 |
| First Received: | August 10, 2001 |
| Last Updated: | August 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00022737 |
| Health Authority: | United States: Federal Government |
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