Status:
WITHDRAWN
OTI-010 for Graft-Versus-Host Disease Prophylaxis in Treating Patients Who Are Undergoing Donor Peripheral Stem Cell Transplantation for Hematologic Malignancies
Lead Sponsor:
Mesoblast International Sàrl
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Graft Versus Host Disease
Leukemia
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
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 (cance...
Detailed Description
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 periphe...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00081055
Last Update
December 4 2014
Active Locations (1)
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1
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1678