In Vivo Treg Expansion and Graft-Versus-Host Disease Prophylaxis

• Status: Completed
• Trial end date: 2017-03-09
• Target enrollment: 0
• Participant gender: All

Summary

IL-2 add-back post allogeneic hematopoietic stem cell transplant (HSCT), combined with Sirolimus (SIR), Tacrolimus (TAC) will optimize Treg reconstitution and prevent graft versus host disease (GVHD).

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

Details

• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Treatments: Aldesleukin; Everolimus; Sirolimus; Tacrolimus

Criteria

Inclusion Criteria:

• Patients must have an available 8/8 human leukocyte antigen (HLA)-A, -B, -C, and -DRB1 matched-related or unrelated donor allogeneic hematopoietic peripheral blood stem cell graft.

• Acute myeloid leukemia, myelodysplasia, acute lymphoblastic leukemia, chronic myeloid leukemia, or myeloproliferative neoplasms requiring a matched allogeneic HSCT.

• Acute Leukemia (AML or ALL) must be in complete remission defined as: <5% marrow blasts with no morphologic evidence of leukemia, no peripheral blasts, marrow >20% cellular, and peripheral absolute neutrophil count >1000/µL (platelet recovery is not required).

• Myelodysplasia (MDS) and chronic myeloid leukemia (CML): Must have <5% marrow blasts.

• Myeloproliferative neoplasms (MPN): Must have <5% peripheral / marrow blasts.

• Adequate vital organ function:

1. Left ventricular ejection fraction (LVEF) ≥ 45% by multi gated acquisition (MUGA) scan or ECHO

2. Forced expiratory volume at one second (FEV1), forced vital capacity (FVC), and adjusted diffusing lung capacity oxygenation (DLCO) ≥ 50% of predicted values on pulmonary function tests

3. Transaminases (AST, ALT) < 2 times upper limit of normal values

4. Creatinine clearance ≥ 50 cc/min.

• Performance status: Karnofsky Performance Status Score ≥ 80%

• Donor eligibility: Eligible donors will include healthy sibling, relative or unrelated donors that are matched with the patient at HLA-A, B, C, and DRB1 by high resolution typing.

Exclusion Criteria:

• Active infection not controlled with appropriate antimicrobial therapy

• History of HIV, hepatitis B, or hepatitis C infection

• Anti-thymocyte globulin, alemtuzumab, bortezomib, or cyclophosphamide administered within 14 days before or planned to receive with HCT conditioning or as part of GVHD prophylaxis in the 14 days after HCT.

• Hypersensitivity to recombinant human IL-2

• Chronic lymphocytic leukemia, Hodgkin lymphoma, and non-hodgkin lymphoma are excluded as these malignancies may express the IL-2 receptor and pose a potential growth signal to any present disease.

• Sorror's co-morbidity factors with total score >4