Chemotherapy and Bone Marrow Transplantation in Treating Patients With Chronic Myelogenous Leukemia
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with autologous bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by autologous bone marrow transplantation in treating patients with chronic myelogenous leukemia.
Biological: c-myb antisense oligonucleotide G4460
Procedure: autologous bone marrow transplantation
Procedure: in vitro-treated bone marrow transplantation
|Study Design:||Primary Purpose: Treatment|
|Official Title:||AUTOLOGOUS BONE MARROW TRANSPLANTATION USING C-MYB (LR-3001) ANTISENSE OLIGODEOXYNUCLEOTIDE TREATED BONE MARROW IN CHRONIC MYELOGENOUS LEUKEMIA IN CHRONIC OR ACCELERATED PHASE|
- Number of Adberse Events
|Study Start Date:||June 1993|
|Study Completion Date:||August 2002|
|Primary Completion Date:||August 2002 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Evaluate the ability of c-myb antisense oligodeoxynucleotide to purge bone marrow cells of clonogenic chronic myelogenous leukemia tumor cells and repopulate the bone marrow with normal stem cells in patients treated with high-dose busulfan and cyclophosphamide followed by autologous bone marrow transplantation using marrow treated with c-myb antisense oligodeoxynucleotide. II. Determine the response rate, degree of hematopoietic reconstitution, overall survival, and relapse-free survival of patients treated with this regimen. III. Determine the toxicity of this regimen in these patients.
OUTLINE: Patients undergo bone marrow harvest. The bone marrow is treated with c-myb antisense oligodeoxynucleotide and cryopreserved. A portion of the marrow is cryopreserved untreated in case of engraftment failure. Patients receive oral busulfan every 6 hours on days -7 to -4 for a total of 16 doses. Patients receive cyclophosphamide IV over 1 hour on days -3 and -2. Bone marrow is reinfused on day 0. Patients receive filgrastim (G-CSF) subcutaneously daily beginning on day 0 and continuing until blood counts recover. Patients are followed every 2-3 months for 2 years.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 18-24 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002592
|United States, Pennsylvania|
|University of Pennsylvania Cancer Center|
|Philadelphia, Pennsylvania, United States, 19104-4283|
|Study Chair:||Selina M. Luger, MD||Abramson Cancer Center of the University of Pennsylvania|