Chemotherapy, Imatinib Mesylate, and Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
This phase II trial studies how well giving imatinib mesylate together with chemotherapy and peripheral stem cell transplantation works in treating patients with newly diagnosed acute lymphoblastic leukemia. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Giving imatinib mesylate together with chemotherapy and peripheral stem cell transplantation may be an effective treatment for acute lymphoblastic leukemia.
Adult Acute Lymphoblastic Leukemia in Remission
Drug: imatinib mesylate
Drug: vincristine sulfate
Drug: leucovorin calcium
Procedure: peripheral blood stem cell transplantation
Procedure: autologous hematopoietic stem cell transplantation
Procedure: allogeneic hematopoietic stem cell transplantation
Radiation: total-body irradiation
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Sequential Chemotherapy, Imatinib Mesylate (Gleevec, STI571) (NSC # 716051), and Transplantation for Adults With Newly Diagnosed Ph+ Acute Lymphoblastic Leukemia by the CALGB and SWOG|
- Disease Free Survival [ Time Frame: Duration of treatment (up to 10 years) ] [ Designated as safety issue: No ]
Disease-free survival (DFS) was measured as the interval from achievement of complete remission (CR) until relapse or death, regardless of cause; patients alive and in CR were censored at last follow-up. DFS was estimated using the Kaplan Meier method.
A complete remission (CR) was defined as recovery of morphologically normal bone marrow and blood counts (i.e., neutrophils >= 1.5 x 10^9/L and platelets > 100 x 10^9/L) and no circulating leukemic blasts or evidence of extramedullary leukemia and persisting for at least one month.
- Overall Survival [ Time Frame: Duration of study (up to 10 years) ] [ Designated as safety issue: No ]Overall survival (OS) as the interval from the on-study date until death. OS was estimated using the Kaplan Meier method.
- Number of Participants Who Achieved a BCR-ABL Response at 12 Months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
BCR-ABL response is defined in two ways: complete molecular response (CMR) and major molecular response (MMR).
Complete Molecular Response is defined as a Bcr-Abl (a fusion of gene of Bcr and ABl genes) ratio ≤0.0032% on the International Scale Bcr = breakpoint cluster gene Abl = abelson proto-oncogene
MMR is defined as Bcr-Abl (A fusion gene of the breakpoint cluster region [Bcr] gene and Abelson proto-oncogene [Abl] genes) transcript ratio ≤0.1% (≥ 3 log reduction of BCR-ABL transcripts from a standardized baseline), as detected by reverse transcriptase polymerase chain reaction [RT-PCR] (performed centrally).
- 5 Year Disease-free Survival for Autologous & Allogeneic Transplant Groups [ Time Frame: 5 years from CR ] [ Designated as safety issue: No ]Percentage of patients who achieved a complete remission (CR) and were alive and relapse free at 5 years. The 5-year progression free survival was estimated using the Kaplan Meier method.
- 5 Year Overall Survival for Autologous & Allogeneic Transplant Groups [ Time Frame: 5 years from registration ] [ Designated as safety issue: No ]Percentage of patients who were alive at 5 years. The 5-year progression free survival was estimated using the Kaplan Meier method.
|Study Start Date:||April 2002|
|Study Completion Date:||February 2014|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
Experimental: Treatment (imatinib mesylate, chemotherapy, PBSCT)
See Detailed Description.
Drug: imatinib mesylate
Other Names:Drug: methotrexate
Given IT and IV
Other Names:Drug: vincristine sulfate
Other Names:Drug: leucovorin calcium
Given IV and PO
Other Names:Procedure: peripheral blood stem cell transplantation
Other Names:Procedure: autologous hematopoietic stem cell transplantation
Undergo autologous PBSCTProcedure: allogeneic hematopoietic stem cell transplantation
Undergo allogeneic PBSCTRadiation: total-body irradiation
Other Name: TBIDrug: tacrolimus
Given IV or PO
Other Names:Biological: filgrastim
Other Names:Drug: etoposide
Other Names:Drug: cyclophosphamide
Other Names:Drug: cytarabine
Other Names:Other: laboratory biomarker analysis
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT00039377
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|Principal Investigator:||Meir Wetzler||Cancer and Leukemia Group B|