This trial is active, not recruiting.

Condition graft-versus-host-disease
Treatments il-2, tacrolimus, sirolimus
Phase phase 2
Targets mTOR, FKBP-12
Sponsor H. Lee Moffitt Cancer Center and Research Institute
Start date March 2014
End date February 2017
Trial size 22 participants
Trial identifier NCT01927120, MCC-17578, NCI-2014-00755


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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose prevention
Graft versus host disease (GVHD) prophylaxis regimen IL-2 with Sirolimus and Tacrolimus after allogeneic hematopoietic cell transplant (HCT)
il-2 Proleukin®
A subcutaneous injection will be administered 3 times a week (separated by at least 1 day between injections), from day 0 to +90 (+/- 7 days).
Will be administered at 0.01 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3
sirolimus Rapamune
Orally on day -1. The dose for loading is 12 mg by mouth (PO)

Primary Outcomes

In Vivo Treg Expansion
time frame: 30 days post transplant

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title In Vivo Treg Expansion and Graft-Versus-Host Disease Prophylaxis With IL-2, Sirolimus, and Tacrolimus Following Allogeneic Hematopoietic Cell Transplantation
Principal investigator Brian Betts, MD
Description 1) Determine if a GVHD prophylaxis regimen of IL-2/SIR/TAC enhances in vivo Treg differentiation and growth; 2) Study the safety and effects of IL-2/SIR/TAC on the incidence of acute and chronic GVHD; 3) Evaluate the influence of dual IL-2 supplementation and mammalian target of rapamycin (mTOR) inhibition on T cell-specific signaling pathways and the polarization of emerging T helper cells.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute.
Location data was received from the National Cancer Institute and was last updated in July 2016.