NCT01366092Active, not recruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 20 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 35 (actual)
- First submitted
- 2 Jun 2011
- Start date
- Jul 2011
- Primary completion date
- Oct 2014
- Lead sponsor
- Dana-Farber Cancer Institute
- NCT number
- NCT01366092
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 35
- From Jul 2011 to the primary completion date, Oct 2014
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent use of calcineurin-inhibitors plus sirolimus
- Organ transplant (allograft) recipient
Other illness
- History of thrombotic microangiopathy, hemolytic-uremic syndrome or thrombotic thrombocytopenic purpura
- Active malignant relapse
- Active uncontrolled infection
- Uncontrolled cardiac angina or symptomatic congestive heart failure
- HIV-positive on combination antiretroviral therapy
- Active hepatitis B or C
Other
- Ongoing prednisone requirement \> 1 mg/kg/day (or equivalent)
- Pregnant or breast-feeding
Who the study is looking for
- Recipient of allogeneic stem cell transplantation with myeloablative or non-myeloablative conditioning regimens
- Steroid refractory cGVHD with systemic therapy onset within the prior 6 months
- No more than 2 prior lines of cGVHD therapy
- Estimated life expectancy \> 3 months
- Adequate organ function
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Beth Israel Deaconess Medical Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.