Decitabine and Peripheral Stem Cell Transplantation in Treating Patients Who Have Relapsed Following Bone Marrow Transplantation for Leukemia, Myelodysplastic Syndrome, or Chronic Myelogenous Leukemia
RATIONALE: Peripheral stem cell transplantation may be an effective treatment for leukemia, myelodysplastic syndrome, or chronic myelogenous leukemia that has relapsed following bone marrow transplantation.
PURPOSE: Phase I/II trial to study the effectiveness of decitabine and peripheral stem cell transplantation in treating patients who have leukemia, myelodysplastic syndrome, or chronic myelogenous leukemia that has relapsed after bone marrow transplantation.
Procedure: Allogeneic Bone Marrow Transplantation
Procedure: Peripheral Blood Stem Cell Transplantation
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II Trial of Decitabine and Allogeneic Peripheral Blood Stem Cells Transplantation for Treatment of Relapse Post Allogeneic Bone Marrow Transplantation|
- Maximum Tolerated Dose (MTD) Decitabine [ Time Frame: Weekly for 1 year ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 1995|
|Study Completion Date:||March 2002|
|Primary Completion Date:||March 2002 (Final data collection date for primary outcome measure)|
|Experimental: Decitabine + Stem Cell Transplantation||
Subcutaneously (SQ) daily every 12 hours starting 2-4 days prior to first PBSC collection then daily starting 1 day after PBSC infusion until blood counts recover.
Other Names:Drug: Cyclosporine
IV daily on day -2, then orally once dose is tolerable, dose may be escalated.
Other Names:Drug: Decitabine
IV for 6 hours every 12 hr for 5 days.
Other Name: DacogenProcedure: Allogeneic Bone Marrow Transplantation
Stem cell infusion on Day 0.
Other Names:Procedure: Peripheral Blood Stem Cell Transplantation
Peripheral blood stem cells (PBSC) are administered 5 days after last dose of decitabine.
Other Name: PBSC
OBJECTIVES: I. Determine the maximum tolerated dose of decitabine in patients with relapse post allogenic bone marrow transplant. II. Determine the toxicity of decitabine combined with filgrastim (G-CSF) primed allogeneic peripheral blood stem cells in patients who relapsed within 1 year after allogeneic bone marrow transplantation. III. Determine the effectiveness in reinducing remission in these patients.
OUTLINE: Patients receive decitabine IV for 6 hours every 12 hr for 5 days. Peripheral blood stem cells (PBSC) are administered 5 days after last dose of decitabine. Donors receive filgrastim subcutaneously (SQ) daily every 12 hours starting 2-4 days prior to first PBSC collection. If insufficient number of cells are collected, bone marrow can be harvested for supplementation. Donor cells should be collected prior to decitabine infusion. Patients receive filgrastim SQ administered daily starting 1 day after PBSC infusion until blood counts recover. For GVHD prophylaxis, patients receive cyclosporine IV daily on day -2, then orally once dose is tolerable. Dose of decitabine is escalated in cohorts of 3-6 patients. If dose limiting toxicity occurs in 2 of 6 patients at a given dose level, then that dose is declared the maximum tolerated dose. Patients are followed weekly. If none of the first 5 patients survive in remission for more than 100 days, the study will be terminated.
PROJECTED ACCRUAL: At least 15 patients will be accrued for this study over 2 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002832
|United States, Texas|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Sergio Giralt, MD||M.D. Anderson Cancer Center|