Leukemia Clinical Trial
Official title:
GRANULOCYTE-MACROPHAGE COLONY STIMULATING FACTOR (Rhu-GM-CSF) FOR REDUCTION OF LEUKEMIC RELAPSE AFTER T-LYMPHOCYTE DEPLETED ALLOGENEIC BMT FOR CHRONIC MYELOID LEUKEMIA
RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from
dividing so they stop growing or die. Combining chemotherapy with allogeneic bone marrow
transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill
more cancer cells. Colony-stimulating factors such as sargramostim may increase the number
of immune cells found in bone marrow or peripheral blood, and may help a person's immune
system recover from the side effects of chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of allogeneic bone marrow transplantation
followed by sargramostim in treating patients who have chronic myelogenous leukemia.
OBJECTIVES:
- Determine whether the use of sargramostim (GM-CSF) after T-cell depleted, CD34-positive
cell-supplemented allogeneic bone marrow transplantation can reduce leukemic relapse in
patients with chronic myelogenous leukemia.
OUTLINE: Patients receive myeloablation with busulfan and cyclophosphamide on an approved
protocol. Allogeneic bone marrow is harvested and treated in vitro with anti-CD34 antibody.
T-cell depleted, CD34-positive cell-supplemented bone marrow is infused on day 0. Patients
receive high-dose sargramostim (GM-CSF) subcutaneously (SC) beginning on day 5 and
continuing until blood counts recover and then low-dose GM-CSF SC continuing until day 60.
Donor lymphocyte infusions or second unmodified allogeneic bone marrow transplantation
without GM-CSF is considered in case of primary or secondary engraftment failure.
Patients are followed every month for 3 months, every 3 months for 1 year, every 6 months
for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within
approximately 6-10 years.
;
Masking: Open Label, Primary Purpose: Treatment
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