Treatment of Bone Marrow to Prevent Graft-Versus-Host Disease in Patients With Acute or Chronic Leukemia Undergoing Bone Marrow Transplantation
Graft Versus Host Disease, Leukemia, Myelodysplastic Syndromes
About this trial
This is an interventional treatment trial for Graft Versus Host Disease focused on measuring recurrent childhood acute lymphoblastic leukemia, recurrent childhood acute myeloid leukemia, recurrent adult acute myeloid leukemia, recurrent adult acute lymphoblastic leukemia, chronic phase chronic myelogenous leukemia, accelerated phase chronic myelogenous leukemia, adult acute myeloid leukemia in remission, adult acute lymphoblastic leukemia in remission, childhood acute myeloid leukemia in remission, childhood acute lymphoblastic leukemia in remission, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, secondary acute myeloid leukemia, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, graft versus host disease, childhood myelodysplastic syndromes
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of one of the following: Acute myelogenous leukemia (AML) or acute lymphocytic leukemia (ALL) in first early relapse, second remission, or subsequent remission AML in first complete remission with one of the following adverse features: Antecedent hematologic disorder such as myelodysplasia AML resulting from prior chemotherapy or radiotherapy More than 1 course of induction chemotherapy to achieve remission or adverse cytogenetics such as Philadelphia chromosome 9:22, +8, +11; abnormal 12p; or deletions of chromosomes 5, 7, or 20 (3:3) ALL in first complete remission with poor risk cytogenetics such as Philadelphia chromosome 9:22, 8:14, or 4:11 OR WBC greater than 100,000/mm3 OR Time to achieve complete remission more than 4 weeks Chronic myelogenous leukemia in chronic or accelerated phase Myelodysplastic syndromes Refractory anemia with excess blasts (RAEB) OR RAEB in transformation Unrelated bone marrow donor available If matched at 6 of 6 HLA-A, -B, and -DR loci, patient must be 12 to 50 years If matched at 5 of 6 loci, patient must be 12 to 35 years No matched sibling donor available No uncontrolled CNS leukemia PATIENT CHARACTERISTICS: Age: See Disease Characteristics 12 to 50 Performance status: Karnofsky 70-100% Life expectancy: At least 12 weeks Hematopoietic: See Disease Characteristics Hepatic: Bilirubin less than 2.5 times upper limit of normal (ULN) SGOT or SGPT less than 2.5 times ULN Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: LVEF greater than 50% without medication Pulmonary: DLCO and FVC at least 50% predicted Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other serious medical illness No uncontrolled diabetes mellitus No uncontrolled and/or active infection HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior immunotherapy and recovered At least 1 year since prior autologous transplantation No prior allogeneic transplantation Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy (except hydroxyurea) and recovered Endocrine therapy: At least 3 weeks since prior hormonal therapy and recovered Radiotherapy: See Disease Characteristics At least 3 weeks since prior radiotherapy and recovered No prior radiotherapy at doses that would preclude study Surgery: Not specified
Sites / Locations
- University of California San Diego Cancer Center
- Presbyterian-St Luke's Medical Center
- Lombardi Cancer Center
- Shands Hospital and Clinics, University of Florida
- Indiana Blood and Marrow Transplantation
- James Graham Brown Cancer Center
- Barbara Ann Karmanos Cancer Institute
- University of Rochester Cancer Center
- New York Medical College
- University of Oklahoma Health Sciences Center
- Oregon Cancer Center
- Hahnemann University Hospital
- University of Texas - MD Anderson Cancer Center
- South Texas Cancer Institute
- Massey Cancer Center