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Study record managers: refer to the Data Element Definitions if submitting registration or information. Combining chemotherapy with allogeneic or autologous stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known whether stem cell transplantation is more effective than standard chemotherapy in treating acute lymphoblastic leukemia.
PURPOSE: This randomized phase III trial is studying how well stem cell transplantation works compared to standard combination chemotherapy in treating patients with acute lymphoblastic leukemia in first remission. Patients are stratified according to age 50 and under vs over 50 , time to achieve complete remission CR 4 weeks or less vs more than 4 weeks , and Philadelphia Ph chromosome status positive vs negative.
Patients with Ph chromosome-positive status and CR after second induction therapy proceed to group I for autologous or allogeneic stem cell transplantation SCT. Patients with Ph chromosome-negative status and CR after second induction therapy proceed to group II. Patients then undergo peripheral blood stem cell collection or bone marrow harvesting.
Patients receive preparative therapy comprising total body irradiation twice daily hours apart on days -6 to -4 and high-dose etoposide VP IV over 4 hours on day Male patients also undergo radiotherapy boost to the testes on day Post-SCT imatinib mesylate therapy: After recovery from autologous or allogeneic SCT, patients receive oral imatinib mesylate once daily. Imatinib mesylate therapy continues in the absence of disease progression or unacceptable toxicity. Approximately patients will be accrued for group II Ph chromosome-negative patients of this study within 5 years.
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Histologically confirmed acute lymphoblastic leukemia ALL. Patients age 50 and under must be HLA typed during induction therapy of study treatment OR provide a written explanation for not undergoing HLA typing. Allogeneic stem cell transplantation patients must meet the following criteria:. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or information.
Search for terms. Save this study. Warning You have reached the maximum of saved studies Listing a study does not mean it has been evaluated by the U. Federal Government. Read our disclaimer for details. Last Update Posted : November 22, Study Description. Show detailed description. Hide detailed description. Detailed Description:. Compare the overall treatment outcomes in patients treated with these regimens.
Determine the effect of imatinib mesylate given after induction therapy in Philadelphia Ph chromosome-positive patients in CR. Determine the benefit of allogeneic or autologous SCT after imatinib mesylate in Ph chromosome-positive patients. Determine the benefit of additional imatinib mesylate administered after allogeneic or autologous SCT in Ph chromosome-positive patients. Determine the minimal residual disease in Ph chromosome-positive patients before and after treatment with imatinib mesylate. Determine the clinical resistance to imatinib mesylate caused by BCR-ABL gene amplification or mutation in Ph chromosome-positive patients.
Second induction therapy: Beginning immediately after first induction therapy, patients receive cyclophosphamide CTX IV over 30 minutes on days 1, 15, and 29; cytarabine ARA-C IV over 30 minutes on days , , , and ; and oral mercaptopurine MP once daily on days Patients with CNS leukemia at presentation also undergo concurrent craniospinal irradiation.
Patients with Ph chromosome-positive status receive oral imatinib mesylate once daily for at least 28 days days Patients also receive filgrastim G-CSF subcutaneously SC once daily beginning on day 5 and continuing until blood counts recover.
Group II Ph chromosome-negative patients : Intensification therapy: Beginning 4 weeks after the completion of the second induction therapy, patients receive high-dose MTX IV over 2 hours on days 1, 8, and 22; leucovorin calcium IV every 6 hours for 4 doses and then orally every 6 hours for 12 doses beginning hours after each MTX infusion; and ASP IV over 30 minutes on days 2, 9, and During course 2 which begins 4 weeks after initiation of course 1 or when blood counts recover , patients receive ARA-C and VP as in course 1.
During course 4 which begins 8 weeks after initiation of course 3 or when blood counts recover , patients receive treatment as in course 2. Maintenance therapy continues for 2. Patients are followed every 6 months for 2 years. FDA Resources. Arms and Interventions. Outcome Measures. Eligibility Criteria.
Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Contacts and Locations. 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. Mary's Regional Cancer Center at St. Francis Cancer Center at St. Layout table for investigator information Study Chair: Jacob M. More Information. IGH translocations, CRLF2 deregulation, and microdeletions in adolescents and adults with acute lymphoblastic leukemia.
J Clin Oncol. Epub Jul Br J Haematol. Epub Mar Epub Oct Epub Feb Epub Nov Epub Nov 8. Differential gene expression patterns and interaction networks in BCR-ABL-positive and -negative adult acute lymphoblastic leukemias. Epub Dec Epub Aug Final analysis and the role of allogeneic transplant in those under 50 years. Early from the international ALL trial. Int J Hematol. Epub Jul 6. Goldstone AH. Transplants in Adult ALL--?
Allo for everyone. Biol Blood Marrow Transplant. Pediatr Blood Cancer. Prognostic relevance of integrated genetic profiling in adult T-cell acute lymphoblastic leukemia. Epub May Epub Jan National Library of Medicine U.
National Institutes of Health U. Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Biological: sargramostim Drug: asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: etoposide Drug: imatinib mesylate Drug: leucovorin calcium Drug: mercaptopurine Drug: methotrexate Drug: prednisone Drug: thioguanine Drug: vincristine sulfate Procedure: allogeneic bone marrow transplantation Procedure: autologous bone marrow transplantation Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy.
Phase 3. Study Type :. Interventional Clinical Trial. Actual Enrollment :. Study Start Date :. Actual Primary Completion Date :. Experimental: Transplant Allogeneic if donor or Autologous if no donor bone marrow transplant. Biological: sargramostim Drug: asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: etoposide Drug: imatinib mesylate Drug: leucovorin calcium Drug: mercaptopurine Drug: methotrexate Drug: prednisone Drug: vincristine sulfate Procedure: allogeneic bone marrow transplantation Procedure: autologous bone marrow transplantation Procedure: peripheral blood stem cell transplantation.
Drug: asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: etoposide Drug: leucovorin calcium Drug: mercaptopurine Drug: methotrexate Drug: prednisone Drug: thioguanine Drug: vincristine sulfate Radiation: radiation therapy.Mc millan MI adult personals
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Stem Cell Transplantation Compared With Standard Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia in First Remission