Graft-Versus-Host-Disease Clinical Trial
Official title:
In Vivo Treg Expansion and Graft-Versus-Host Disease Prophylaxis With IL-2, Sirolimus, and Tacrolimus Following Allogeneic Hematopoietic Cell Transplantation
Verified date | March 2017 |
Source | H. Lee Moffitt Cancer Center and Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Active, not recruiting |
Enrollment | 21 |
Est. completion date | January 2018 |
Est. primary completion date | August 25, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
H. Lee Moffitt Cancer Center and Research Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | In Vivo Treg Expansion | Proportion of Treg among blood CD4+ T cells at day 30 after hematopoietic cell transplantation (HCT) | 30 days post transplant |
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