Total-Body Irradiation Plus Stem Cell Transplantation And White Blood Cell Infusion in Treating O… (NCT00005801) | Clinical Trial Compass
CompletedPhase 2
Total-Body Irradiation Plus Stem Cell Transplantation And White Blood Cell Infusion in Treating Older Patients With Acute Myeloid Leukemia
United StatesStarted 1999-11
Plain-language summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by radiation therapy used to kill tumor cells. Infusions of donor white blood cells may decrease the body's rejection of the transplanted peripheral stem cells.
PURPOSE: Phase II trial to study the effectiveness of combining radiation therapy, peripheral stem cell transplantation, and donor white blood cell infusions in treating older patients who have acute myeloid leukemia.
Who can participate
Age range55 Years – 74 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS: Acute myeloid leukemia (AML) (de novo or secondary, FAB M1, M2 and M4-7) Must be within 6 months of diagnosis Achieved a chemotherapy induced first complete remission (CR) Received 1 or more courses of consolidation chemotherapy OR AML in second or greater CR Patients with a documented first or subsequent CR may proceed to transplantation if: No morphologic diagnosis of AML or myelodysplastic syndrome Absolute neutrophil count greater than 1,000/mm3 and platelet count greater than 50,000/mm3 after any consolidation chemotherapy Availability of an HLA identical related peripheral blood stem cell donor No syngeneic donor No active CNS leukemia
PATIENT CHARACTERISTICS: Age: Over 55 to under 75 Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) ALT and AST less than 4 times ULN Renal: Creatinine clearance at least 50 mL/min Cardiovascular: Cardiac ejection fraction at least 40% No poorly controlled hypertension Pulmonary: No severe defects in pulmonary function testing No requirement for supplementary continuous oxygen
PRIOR CONCURRENT THERAPY: See Disease Characteristics