CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
IL-2 +2 moredrug
Likely dose
Tacrolimus 0.01 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01927120
NCT01927120Phase 2Completed
CompareCT.gov

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

H. Lee Moffitt Cancer Center and Research Institute·interventional·Posted Aug 22, 2013·Updated Jul 2, 2017

In Brief

A Phase 2 clinical trial evaluating IL-2, Tacrolimus, and 1 other intervention for Graft-Versus-Host-Disease. Completed, enrolled 20 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGraft-Versus-Host-Disease
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 22, 2013
Enrollment StartMar 25, 2014
Primary CompletionAug 25, 2016
Study CompletionMar 9, 2017
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 12.9 years ago

Interventions

IL-2drug

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).

Tacrolimusdrug

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

Sirolimusdrug

Orally on day -1. The dose for loading is 12 mg by mouth (PO)