OTI-010 for Graft-Versus-Host Disease Prophylaxis in Treating Patients Who Are Undergoing Donor Peripheral Stem Cell Transplantation for Hematologic Malignancies
Graft Versus Host Disease, Leukemia, Myelodysplastic Syndromes
About this trial
This is an interventional supportive care trial for Graft Versus Host Disease focused on measuring graft versus host disease, adult acute lymphoblastic leukemia in remission, recurrent adult acute lymphoblastic leukemia, adult acute myeloid leukemia in remission, recurrent adult acute myeloid leukemia, accelerated phase chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia, refractory anemia, refractory anemia with excess blasts, refractory anemia with ringed sideroblasts, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, adult acute myeloid leukemia with t(8;21)(q22;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with t(15;17)(q22;q12)
Eligibility 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)
Sites / Locations
- Jonsson Comprehensive Cancer Center, UCLA