Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous or Acute Leukemia
- Conditions
- Leukemia
- Interventions
- Biological: FilgrastimProcedure: Allogeneic Bone Marrow TransplantationProcedure: Peripheral Blood Stem Cell Transplantation
- Registration Number
- NCT00002831
- Lead Sponsor
- M.D. Anderson Cancer Center
- Brief Summary
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 drugs and kill more cancer cells.
PURPOSE: Phase I/II trial to study the effectiveness of high-dose chemotherapy plus peripheral stem cell transplantation in treating patients with chronic myelogenous or acute leukemia.
- Detailed Description
OBJECTIVES: I. Determine the maximum tolerated dose of decitabine in combination with busulfan and cyclophosphamide in patients with hematologic malignancies. II. Establish the pharmacokinetics of decitabine and busulfan in this patient population. III. Determine the effectiveness of this combination in achieving durable complete remission in patients with chronic myelogenous leukemia (CML) in blast crisis or acute myelogenous leukemia (AML) in relapse undergoing allogeneic stem cell transplantation.
OUTLINE: In cohorts of 3, patients receive escalating doses of decitabine (DAC) IV over 4 hours on days -8 and -7. Busulfan is administered orally every 6 hours on consecutive days -6 through -4. Cyclophosphamide is given by vein (IV) over 1 hour on consecutive days -3 and -2. The maximum tolerated dose of DAC is defined as the dose at which 2 patients experience dose limiting toxicity. Donors receive filgrastim subcutaneously (SQ) daily every 12 hours starting 2-4 days prior to the first stem cell collection and before DAC infusion. Leukapheresis is conducted daily. If insufficient number of cells are collected, blood marrow is harvested for supplementation. Stem cells are infused on day 0. For graft vs host disease prophylaxis (GVHD), patients receive tacrolimus IV beginning one day before stem cell infusion, then orally following tolerance to tacrolimus. Patients intolerant to tacrolimus receive cyclosporine IV beginning on day -2, then orally following tolerance and engraftment. All patients receive methylprednisolone given according to clinical grade of GVHD procedures. For CNS prophylaxis, methotrexate is given intrathecally or intraventricularly monthly, beginning on the second month through the eighth month of treatment. Allogeneic patients are followed until the end of 1 year.
PROJECTED ACCRUAL: An estimated 30 allogeneic recipients will be recruited in 2 years for the expected study duration of 2-3 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Deoxyazacytidine + Busulfan + Cyclophosphamide Filgrastim Deoxyazacytidine + Busulfan + Cyclophosphamide With Allogeneic Stem Cell Transplantation Deoxyazacytidine + Busulfan + Cyclophosphamide Decitabine (DAC) Deoxyazacytidine + Busulfan + Cyclophosphamide With Allogeneic Stem Cell Transplantation Deoxyazacytidine + Busulfan + Cyclophosphamide Tacrolimus Deoxyazacytidine + Busulfan + Cyclophosphamide With Allogeneic Stem Cell Transplantation Deoxyazacytidine + Busulfan + Cyclophosphamide Allogeneic Bone Marrow Transplantation Deoxyazacytidine + Busulfan + Cyclophosphamide With Allogeneic Stem Cell Transplantation Deoxyazacytidine + Busulfan + Cyclophosphamide Peripheral Blood Stem Cell Transplantation Deoxyazacytidine + Busulfan + Cyclophosphamide With Allogeneic Stem Cell Transplantation Deoxyazacytidine + Busulfan + Cyclophosphamide Busulfan Deoxyazacytidine + Busulfan + Cyclophosphamide With Allogeneic Stem Cell Transplantation Deoxyazacytidine + Busulfan + Cyclophosphamide Cyclophosphamide Deoxyazacytidine + Busulfan + Cyclophosphamide With Allogeneic Stem Cell Transplantation Deoxyazacytidine + Busulfan + Cyclophosphamide Cyclosporine Deoxyazacytidine + Busulfan + Cyclophosphamide With Allogeneic Stem Cell Transplantation Deoxyazacytidine + Busulfan + Cyclophosphamide Methotrexate Deoxyazacytidine + Busulfan + Cyclophosphamide With Allogeneic Stem Cell Transplantation Deoxyazacytidine + Busulfan + Cyclophosphamide Methylprednisolone Deoxyazacytidine + Busulfan + Cyclophosphamide With Allogeneic Stem Cell Transplantation
- Primary Outcome Measures
Name Time Method Maximum Tolerated Dose Study Duration 3 Years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States