Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Chronic Lymphocytic Leukemia
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy and kill more cancer cells.
PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients with refractory chronic lymphocytic leukemia.
|Leukemia||Biological: Filgrastim (G-CSF) Drug: Cyclophosphamide Drug: Fludarabine Phosphate Procedure: Peripheral Blood Stem Cell Transplantation||Phase 1 Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II Pilot Study of Allogeneic Peripheral Blood Stem Cell Infusion For Patients With High Risk Chronic Lymphocytic Leukemia|
- Feasibility + Toxicity of Combination Chemotherapy Plus Peripheral Stem Cell Transplantation [ Time Frame: Monthly ]
|Study Start Date:||December 1995|
|Study Completion Date:||July 2002|
|Primary Completion Date:||July 2002 (Final data collection date for primary outcome measure)|
Experimental: Combination Chemotherapy + PSCT
PSCT = Peripheral Stem Cell Transplantation
Biological: Filgrastim (G-CSF)
Other Names:Drug: Cyclophosphamide
Other Names:Drug: Fludarabine Phosphate
Other Name: FludaraProcedure: Peripheral Blood Stem Cell Transplantation
OBJECTIVES: I. Determine the feasibility and toxicity of using allogeneic peripheral blood stem cell transplantation after intensive, but non-myeloablative chemotherapy with fludarabine/cyclophosphamide in patients with advanced chronic lymphocytic leukemia. II. Determine the engraftment kinetics and degree of chimerism available with this strategy.
OUTLINE: This is a nonrandomized, dose-seeking study. Stem cell donors receive G-CSF for 4 days prior to and throughout stem cell harvest. Patients receive intensive chemotherapy with fludarabine and cyclophosphamide for 3 days, with patients entered at increasing doses of both drugs until the dose allowing engraftment is determined. Three days after intensive chemotherapy, allogeneic stem cells are infused. Responding patients who do not experience worse than grade 1 acute graft-vs.-host disease receive additional stem cell infusions after 60 and 120 days. Patients are followed monthly for 4 months, at 6 and 12 months, then yearly for 5 years.
PROJECTED ACCRUAL: Up to 25 patients will be entered.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002838
|United States, Texas|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Issa Khouri, MD||M.D. Anderson Cancer Center|