Acute Myeloid Leukemia Clinical Trial
Filgrastim-Treated Donor Peripheral Stem Cell Transplantation in Treating Patients With Acute Leukemia
Summary
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.
Full Description
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.
Eligibility Criteria
DISEASE CHARACTERISTICS:
One of the following diagnoses:
Primary acute leukemia beyond first remission
High-risk acute myelogenous leukemia
Acute lymphoblastic leukemia in first remission
Must have HLA-matched donor identical for HLA-A, -B, and DRB1 alleles
No HLA-matched identical sibling or haploidentical relative incompatible for 0 or 1 HLA-A, -B, or -DRB1 loci on the non-shared haplotype
No leukoencephalopathy
PATIENT CHARACTERISTICS:
Age:
55 and under
Performance status:
Not specified
Life expectancy:
Not specified
Hematopoietic:
Not specified
Hepatic:
SGOT no greater than 2 times normal
Hepatitis B surface antigen negative
No prior hepatitis C
Renal:
No impaired renal function
Creatinine less than 2 times normal
Cardiovascular:
No symptomatic cardiac disease
Pulmonary:
No active pulmonary disease
DLCO at least 60% predicted
Other:
HIV negative
No disease or other malignancy that severely limits life expectancy
No severe or life-threatening infection within the past 2 weeks
No history of septate fungal infection or disseminated candidiasis
PRIOR CONCURRENT THERAPY:
Biologic therapy:
No prior bone marrow or peripheral blood stem cell transplantation
Chemotherapy:
Not specified
Endocrine therapy:
Not specified
Radiotherapy:
No prior radiotherapy greater than 3,000 cGy to whole brain
No prior radiotherapy of 1,500 cGy to chest or abdomen
At least 6 months since prior involved-field radiotherapy to chest or abdomen
Surgery:
Not specified
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There is 1 Location for this study
Seattle Washington, 98109, United States
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