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Can a daily shot of IL-2 tame chronic GVHD?

NCT ID NCT01366092

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

35 people

The number who actually took part.

Start date

Jul 2011

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

Bronchiolitis Obliterans Syndrome chronic graft versus host disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02214, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02214, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.