OTI-010 for Graft-Versus-Host Disease Prophylaxis in Treating Patients Who Are Undergoing Donor Peripheral Stem Cell Transplantation for Hematologic Malignancies

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed diagnosis of 1 of the following hematologic malignancies:
• •* Acute lymphoblastic leukemia, meeting 1 of the following criteria:
• •* In first or second remission
• •* In early first or second relapse\*
• •* Acute myeloid leukemia, meeting 1 of the following criteria:
• •* In first or second remission
• •* In early first or second relapse\*
• •* Chronic myelogenous leukemia
• •* Chronic or accelerated phase
• •* Any of the following myelodysplastic syndromes:
• •* Refractory anemia (RA)
• •* RA with ringed sideroblasts
• •* RA with excess blasts NOTE: \*\< 24% marrow blasts and \< 5% peripheral blood blasts (within 10 days of beginning conditioning regimen)
• •No secondary acute leukemia
• •Prior CNS tumor involvement allowed provided patient is asymptomatic and there is no evidence of CNS disease on lumbar puncture and CT scan of the brain
• •Must have a 6/6 HLA-identical sibling donor available
• •PATIENT CHARACTERISTICS:
• •Age
• •18 to 55
• •Performance status
• •Karnofsky 70-100%
• •Life expectancy
• •Not specified
• •Hematopoietic
• •Not specified
• •Hepatic
• •Bilirubin \< 2 times upper limit of normal (ULN)
• •SGOT \< 10 times ULN
• •Hepatitis B core antigen, surface antigen, and e-antigen negative
• •Hepatitis B DNA negative
• •Hepatitis C RNA negative
• •Renal
• •Creatinine clearance ≥ 60 mL/min
• •Cardiovascular
• •LVEF ≥ 50% by MUGA or echocardiogram
• •No right sided heart failure
• •Pulmonary
• •FEV\_1 \> 50% of predicted
• •DLCO ≥ 50% of predicted (corrected for anemia)
• •Oxygen saturation ≥ 97% on room air
• •No pulmonary hypertension
• •Immunologic
• •HIV-1 and 2 antibody negative
• •HIV-1 antigen negative
• •HTLV-I and II antibody negative
• •No active infection
• •Other
• •CNS function normal
• •No uncontrolled alcohol or substance abuse within the past 6 months
• •No other concurrent underlying medical condition that would preclude study participation
• •Not pregnant
• •Negative pregnancy test
• •Fertile patients must use 2 effective methods of contraception
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy
• •No prior allogeneic or autologous hematopoietic stem cell transplantation
• •No concurrent medication to accelerate neutrophil or platelet engraftment except filgrastim (G-CSF)
• •Chemotherapy
• •Not specified
• •Endocrine therapy
• •Not specified
• •Radiotherapy
• •Not specified
• •Surgery
• •No prior solid organ transplantation
• •Other
• •More than 30 days since prior investigational agents or devices
• •No other concurrent investigational agents or devices
• •No concurrent anti-infective therapy except prophylactic therapy
• •No other concurrent conditioning regimen agents
• •No concurrent herbal remedies except multivitamins
• •No other concurrent graft-versus-host disease prophylaxis medications (e.g., ursodeoxycholic acid)