Leukemia Clinical Trial
Official title:
A Phase II Trial to Evaluate the Use of G-CSF-Mobilized Peripheral Blood Progenitor Cells as Hematopoietic Rescue in Patients With Acute Leukemia Undergoing Allografting From an Unrelated Donor
RATIONALE: Transplanted peripheral stem cells can sometimes be rejected by the body's
tissues. Treating donor peripheral stem cells with filgrastim may increase the number of
donor white blood cells. This may help to decrease the rejection of the transplanted cells
in patients receiving them as treatment for acute leukemia.
PURPOSE: Phase II trial to study the effectiveness of filgrastim-treated donor peripheral
stem cells in treating patients with acute leukemia who are undergoing peripheral stem cell
transplantation.
OBJECTIVES:
- Determine whether filgrastim (G-CSF)-mobilized allogeneic peripheral blood stem cell
transplantation reduces the incidence of non-leukemic mortality in patients with acute
leukemia.
- Determine the kinetics and durability of engraftment after treatment with this regimen
in these patients.
- Determine the incidence and severity of acute and chronic graft-versus-host disease in
patients treated with this regimen.
- Determine the leukemia-free survival of patients treated with this regimen.
OUTLINE: Donors receive filgrastim (G-CSF) subcutaneously (SC) on days -5 to -1. Donors then
undergo leukapheresis on days -1 and 0.
Patients undergo total body irradiation twice daily on days -7 to -4. Patients receive 2
doses of intrathecal methotrexate per local guidelines between days -10 and -3. Patients
also receive cyclophosphamide IV on days -3 and -2. Patients receive infusion of allogeneic
peripheral blood stem cells on day 0.
PROJECTED ACCRUAL: A total of 5-60 patients will be accrued for this study within 3 years.
;
Masking: Open Label, Primary Purpose: Treatment
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