CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 29 enrolled
Drug / intervention
Interleukin-2drug
Likely dose
Not stated in 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/NCT00529035
NCT00529035Phase 1Completed
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A Phase I Study of Ultra-Low Dose Subcutaneous Interleukin-2 (IL-2) for Treatment of Refractory Chronic Graft Versus Host Disease

Dana-Farber Cancer Institute·interventional·Posted Sep 14, 2007·Updated Jul 1, 2020

In Brief

A Phase 1 clinical trial evaluating Interleukin-2 for Graft Versus Host Disease. Completed, enrolled 29 participants across 1 site.

Detailed Summary

The purpose of this research study is to determine the safety of IL-2 and the highest dose of this drug that can be given safely to people with chronic graft versus host disease (GVHD). Chronic GVHD is a medical condition that may occur after patients receive a bone marrow, stem cell or cord blood transplant. The donor's immune system may recognize their body (the host) as foreign and attempt to "reject" it. Traditional standard therapy to treat chronic GVHD is prednisone (steroids). Treatment options are limited, and it is thought that IL-2 may help to control chronic GVHD.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGraft Versus Host Disease
CountriesUnited States
CollaboratorsBrigham and Women's Hospital, Novartis

Timeline

Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 14, 2007
Enrollment StartAug 1, 2007
Primary CompletionJun 1, 2011
Study CompletionMay 27, 2020
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 18.8 years ago

Interventions

Interleukin-2drug

Dose will vary depending upon when participant enters the trial: Given as a daily injection under the skin for 8 weeks.