NCT01366092

Daily IL-2 for Steroid-Refractory Chronic Graft-versus-Host-Disease

A Phase II Trial of Daily Low-Dose Interleukin-2 (IL-2) for Steroid-Refractory Chronic Graft-Versus-Host-Disease

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Chronic GVHD is a medical condition that may occur after a bone marrow, stem cell or cord blood transplant. The donor's immune system may recognize the your body (the host) as foreign and attempt to 'reject' it. This process is known as graft-versus-host-disease. It is thought that IL-2 may help control chronic GVHD by stopping the donor's immune system from 'rejecting' your body. In this research study, we are looking to see how IL-2 can be used in combination with steroids to treat cGVHD.

Detailed description

You will give yourself or be given IL-2 daily through an injection under your skin. You should rotate the injection site, if possible. You will do this once every day for 12 weeks. You will then have 4 weeks off of IL-2. During the first 6 weeks of IL-2, you will continue to take steroids without changing the dose your doctor has set for you while you are on IL-2. After 6 weeks of IL-2 therapy, your doctor may reduce the amount of steroids you take. While you are on study, a member of the study team will examine you to evaluate your cGVHD. These assessments may include examination of your skin, joints/muscles, eyes, mouth, lungs and gastrointestinal system. You will have clinic visits for evaluation of toxicity and clinical benefit approximately every 4 weeks. You will also have immunologic assays approximately every 8 weeks. Immunologic assays will measure the effect of IL-2 on immune cells. You will be on the study for about 16 weeks. You may continue on study treatment for longer if you experience a clinical benefit.

Conditions

• Chronic Graft-versus-host Disease

Interventions

Type	Name	Description
DRUG	Interleukin-2	Daily subcutaneous IL-2 (1 x 10\^6 IU/m\^2/day) for self-administration for 12 weeks followed by 4-week hiatus

Timeline

• Start date: 2011-07-01
• Primary completion: 2014-10-01
• Completion: 2026-12-01
• First posted: 2011-06-03
• Last updated: 2026-02-20
• Results posted: 2015-01-15

Locations

3 sites across 1 country: United States