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Home > "F" Clinical Trials Conditions > Filgrastim-Treated Donor Peripheral Stem Cell Transplantation in Treating Patients With Acute Leukemia  Filgrastim-Treated Donor Peripheral Stem Cell Transplantation in Treating Patients With Acute Leukemia
Filgrastim-Treated Donor Peripheral Stem Cell Transplantation in Treating Patients With Acute Leukemia
For Condition: adult acute lymphoblastic leukemia in remission,recurrent childhood acute myeloid leukemia,childhood acute lymphoblastic leukemia in remission,recurrent childhood acute lymphoblastic leukemia,recurrent adult acute lymphoblastic leukemia,secondary acute myeloid leukemia,acute undifferentiated leukemia,recurrent adult acute myeloid leukemia
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Fred Hutchinson Cancer Research Center
Synopsis: 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.
Details: OBJECTIVES: I. Determine whether filgrastim (G-CSF)-mobilized allogeneic peripheral blood stem cell transplantation reduces the incidence of non-leukemic mortality in patients with acute leukemia. II. Determine the kinetics and durability of engraftment after treatment with this regimen in these patients. III. Determine the incidence and severity of acute and chronic graft-versus-host disease in patients treated with this regimen. IV. Determine the leukemia-free survival of patients treated with this regimen. PROTOCOL 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /55 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ClaudioAnasetti, Study Chair, Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
United States
Additional Information:
Study ID Numbers: CDR0000068972; FHCRC-1099.00,NCI-H01-0078
Study Start Date: March 1996
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00025545
Other Recurrent Childhood Acute Lymphoblastic Leukemia Studies:
1. Monoclonal Antibody Therapy in Treating Patients With Chronic Lymphocytic Leukemia, Lymphocytic Lymphoma, Acute Lymphoblastic Leukemia, or Acute Myeloid Leukemia
2. Graft-Versus-Host Disease Prevention in Treating Patients Who Are Undergoing Bone Marrow Transplantation
3. BMS-214662 in Treating Patients With Acute Leukemia, Myelodysplastic Syndrome, or Chronic Myeloid Leukemia
4. 506U78 in Treating Patients With Refractory or Relapsed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
5. Fludarabine and Total-Body Irradiation Followed By Donor Peripheral Stem Cell Transplantation in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Has Responded to Treatment With Imatinib Mesylate
Related Studies:
Other recurrent childhood acute lymphoblastic leukemia Clinical Trials
Other Washington Clinical Trials
Other Seattle Clinical Trials
Filgrastim-Treated Donor Peripheral Stem Cell Transplantation in Treating Patients With Acute Leukemia
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