Chemotherapy, Imatinib Mesylate, and Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
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|ClinicalTrials.gov Identifier: NCT00039377|
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : March 18, 2014
Last Update Posted : November 24, 2014
|Condition or disease||Intervention/treatment||Phase|
|Adult Acute Lymphoblastic Leukemia in Remission||Drug: imatinib mesylate Drug: methotrexate 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 Drug: tacrolimus Biological: filgrastim Drug: etoposide Drug: cyclophosphamide Drug: cytarabine Other: laboratory biomarker analysis||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||58 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||April 2002|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||February 2014|
Experimental: Treatment (imatinib mesylate, chemotherapy, PBSCT)
See Detailed Description.
Drug: imatinib mesylate
Given IT and IV
Drug: vincristine sulfate
Drug: leucovorin calcium
Given IV and PO
Procedure: peripheral blood stem cell transplantation
Procedure: autologous hematopoietic stem cell transplantation
Undergo autologous PBSCT
Procedure: allogeneic hematopoietic stem cell transplantation
Undergo allogeneic PBSCT
Radiation: total-body irradiation
Other Name: TBI
Given IV or PO
Other: laboratory biomarker analysis
- Disease Free Survival [ Time Frame: Duration of treatment (up to 10 years) ]
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) ]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 ]
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 ]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 ]Percentage of patients who were alive at 5 years. The 5-year progression free survival was estimated using the Kaplan Meier method.
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): NCT00039377
|Principal Investigator:||Meir Wetzler||Cancer and Leukemia Group B|