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

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 (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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mesoblast International Sàrl
• Collaborator: National Cancer Institute (NCI)
• Treatments: Busulfan; Cyclophosphamide; Cyclosporine; Cyclosporins; Methotrexate

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)