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

Completed · Phase 2

Conditions studied: Graft-Versus-Host-Disease

In brief

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).

Key facts

Study ID

NCT01927120

Run by

H. Lee Moffitt Cancer Center and Research Institute

People needed

20

Starts

2014-03-25

Expected to finish

2017-03-09

Last updated by the study team

2017-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• Left ventricular ejection fraction (LVEF) ≥ 45% by multi gated acquisition (MUGA) scan or ECHO
• 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
• Transaminases (AST, ALT) < 2 times upper limit of normal values
• 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.

You may not qualify if…

• 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

Where it is running

• H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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