Leukemia Clinical Trial
Official title:
A Phase I/II Study of High-Dose Deoxyazacytidine, Busulfan, and Cyclophosphamide With Allogeneic Stem Cell Transplantation for Hematologic Malignancies
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.
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.
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