Expired Study
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Los Angeles, California 90095


Purpose:

RATIONALE: OTI-010 may be effective for graft-versus-host disease prophylaxis (prevention) in patients who are undergoing donor peripheral stem cell transplantation for hematologic malignancies (cancer of the blood or bone marrow). PURPOSE: This randomized phase II trial is studying how well OTI-010 works in preventing graft-versus-host disease in patients who are undergoing donor peripheral stem cell transplantation for hematologic cancer.


Study summary:

OBJECTIVES: - Compare the safety and efficacy of OTI-010 vs placebo as graft-versus-host disease prophylaxis in patients with hematologic malignancies undergoing HLA-identical sibling matched peripheral blood stem cell transplantation. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to age (18 to 34 vs 35 to 55) and donor/recipient gender (female donor/male recipient vs female donor/female recipient vs male donor/female recipient vs male donor/male recipient). - Conditioning regimen: Patients receive cyclophosphamide IV once daily on days -5 and -4 and undergo total body irradiation twice daily on days -3 to -1 OR busulfan IV over 2 hours every 6 hours on days -7 to -4 and cyclophosphamide IV once daily on days -3 and -2. - Graft-versus-host disease prophylaxis: Patients receive methotrexate IV on days 1, 3, 6, and 11. Patients also receive cyclosporine orally or IV (over 1-4 hours) twice daily beginning on day -1 and continuing for at least 6 months followed by a taper until 1 year after transplantation. - OTI-010 therapy: Patients are randomized to 1 of 3 treatment arms. - Arm I: Patients receive placebo IV 4 hours before peripheral blood stem cell transplantation (PBSCT) on day 0. - Arm II: Patients receive OTI-010 IV 4 hours before PBSCT on day 0. - Arm III: Patients receive a higher dose of OTI-010 IV 4 hours before PBSCT on day 0. - Allogeneic stem cell transplantation: Patients undergo allogeneic PBSCT on day 0. Patients are followed at 18 weeks, at 6, 9, and 12 months, every 6 months for 1 year, and then annually for 3 years. PROJECTED ACCRUAL: A total of 99 patients (33 per treatment arm) will be accrued for this study within 5 months.


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)


NCT ID:

NCT00081055


Primary Contact:

Principal Investigator
Mary C. Territo, MD
Jonsson Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Los Angeles, California 90095
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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