NCT01927120

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

In Vivo Treg Expansion and Graft-Versus-Host Disease Prophylaxis With IL-2, Sirolimus, and Tacrolimus Following Allogeneic Hematopoietic Cell Transplantation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Graft-Versus-Host-Disease

Interventions

Type	Name	Description
DRUG	IL-2	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).
DRUG	Tacrolimus	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
DRUG	Sirolimus	Orally on day -1. The dose for loading is 12 mg by mouth (PO)

Timeline

• Start date: 2014-03-25
• Primary completion: 2016-08-25
• Completion: 2017-03-09
• First posted: 2013-08-22
• Last updated: 2017-07-02
• Results posted: 2017-07-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study