A Phase 2/3 interventional study of anti-thymocyte globulin and filgrastim in Graft Versus Host Disease, Leukemia and Myelodysplastic Syndromes, sponsored by Chimeric Therapies. Completed at 15 sites in United States. Open to participants aged 12 Years to 50 Years. Per ClinicalTrials.gov, last updated 2013-07-10.
Sponsored by Chimeric Therapies · Phase 2/3, Interventional, and Treatment
RATIONALE: Bone marrow that has been treated to remove certain white blood cells may reduce the chance of developing graft-versus-host disease following bone marrow transplantation.
PURPOSE: Randomized phase II/III trial to compare the effectiveness of treated bone marrow with that of untreated bone marrow in preventing graft-versus-host disease in patients with acute or chronic leukemia who are undergoing bone marrow transplantation.
OBJECTIVES:
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to degree of HLA matching and disease (chronic vs acute). Acute myelogenous leukemia patients are further stratified according to prior myelodysplastic syndromes (yes vs no). Patients are randomized to one of two bone marrow transplantation arms.
All patients receive a conditioning regimen comprising fludarabine IV on day -6, cyclophosphamide IV on days -5 and -4, anti-thymocyte globulin IV on days -4 and -2, and total body irradiation on days -3 to 0. Patients also receive methylprednisolone IV every 12 hours for 4 doses on days -2 to 0. Tacrolimus IV is administered continuously on day -1 and continues either orally or IV for 6 months. Bone marrow is infused on day 0. Filgrastim (G-CSF) is administered subcutaneously from day 0 until blood counts recover.
PROJECTED ACCRUAL: A total of 260 patients will be accrued for this study within 17 months.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
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DISEASE CHARACTERISTICS:
Diagnosis of one of the following:
AML in first complete remission with one of the following adverse features:
ALL in first complete remission with poor risk cytogenetics such as
Myelodysplastic syndromes
Unrelated bone marrow donor available
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
This study is completed, as verified in Feb 2002. You cannot join it, but the record below documents what was studied.
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