Imatinib Mesylate, Busulfan, Fludarabine, Antithymocyte Globulin and Allogeneic Stem Cell Transplantation for Chronic Myelogenous Leukemia
Patients will have blood and bone marrow tests performed as well as chest and sinus X-rays
and tests of their heart and lung function. Approximately 5 tablespoons of blood will be
All patients in this study will receive imatinib mesylate by mouth for 9 days, unless the
patient is known to be allergic or have symptomatic intolerance to the drug, or if the
leukemia has failed to respond to imatinib. Fludarabine 40 mg/m2 by vein for 4 days (days
-5 to -2), busulfan 130 mg/m2 by vein for 2 days (days -3 and -2), and ATG (Antithymocyte
Globulin) 2.5 mg/kg by vein for 3 days (-3,-2 and -1).
Patients will then receive the donor bone marrow or blood stem cells by vein over
approximately one hour on day 0.
After the infusion of the donor cells, you will receive immunosuppressive therapy with
tacrolimus and methotrexate to decrease the risk of developing graft-vs-host disease (GvHD).
Patients will need frequent blood tests to monitor their counts and blood chemistries. This
is generally done daily while in hospital and at least twice per week for the first 100 days
post transplant. You may need frequent blood transfusions and may have to be admitted to
the hospital to receive antibiotics if they develop fever. Bone marrow will be examined
frequently beginning four weeks after treatment to evaluate response to treatment; Blood and
bone marrow exams are to be performed at one, two three, six, 12 and 18 months post
transplant and yearly thereafter for 5 years. To collect a bone marrow sample, an area of
the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is
withdrawn through a large needle.
Patients in whom treatment produces a remission, in which no sign of the leukemia can be
detected, will receive no further therapy unless the leukemia recurs. Patients with
evidence of leukemia after 3 months from the transplant will receive additional treatment
with imatinib mesylate; those with detectable leukemia after an additional 3 months may
receive an infusion of immune cells from the transplant donor.
If there is evidence of leukemia after the transplant, you will receive additional treatment
with imatinib mesylate. If leukemia cells can still be detected, additional donor immune
cells will be given to you by vein.
Patients are considered on the study for 5 years after the transplant.
A total of 90 patients will take part in this study. All will be enrolled at M. D.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants in Complete Molecular Remission at 1 Year
Participants at 1 year in molecular remission, post transplant, post imatinib mesylate and donor lymphocyte infusion (DLI). Molecular remission is a complete remission with no evidence of disease in the blood cells and/or bone marrow using sensitive polymerase chain reaction (PCR) tests (this test is most commonly used in clinical trials).
Baseline to 1 year
Richard E. Champlin, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
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