Can a daily shot of IL-2 tame chronic GVHD?
NCT ID NCT01366092
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether daily low-dose injections of interleukin-2 (IL-2) can help control chronic graft-versus-host disease (cGVHD) in 35 people who did not respond to steroids. cGVHD is a complication after a stem cell transplant where the donor's immune cells attack the recipient's body. The study aims to see if IL-2 can reduce cGVHD symptoms and allow patients to lower their steroid use.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Interleukin-2 (IL-2)
- What this could lead to
- If it works, this could offer a new way to control chronic GVHD without high-dose steroids, potentially improving quality of life for transplant recipients.
- What could go wrong
- This is a small, early-phase trial with only 35 participants. The treatment may not work for everyone, and side effects from IL-2 are possible. Results need confirmation in larger studies.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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35 people
The number who actually took part.
- Start date
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Jul 2011
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * Ongoing prednisone requirement \> 1 mg/kg/day (or equivalent) * Concurrent use of calcineurin-inhibitors plus sirolimus * 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 * Organ transplant (allograft) recipient * HIV-positive on combination antiretroviral therapy * Active hepatitis B or C * Pregnant or breast-feeding
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
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Dana-Farber Cancer Institute
Boston, Massachusetts, 02214, United States
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Massachusetts General Hospital
Boston, Massachusetts, 02214, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Stem cell infusions put to the test against a tough transplant complication
- Can adding rituximab improve remission in chronic GVHD?
- Can a new pill tame the immune System's attack after stem cell transplants?
- Can a new pill outperform standard care for a tough transplant complication?
- Can meditation tame the Long-Term side effects of a stem cell transplant?
- Could a liquid form of a Graft-Versus-Host disease drug be as effective as the pill?