Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Experimental combo for Graft-Versus-Host disease fails to enroll

NCT ID NCT01453140

Disease control Sponsor: Hackensack Meridian Health Source: ClinicalTrials.gov ↗

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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a mix of drugs (cyclophosphamide, sirolimus, low-dose IL-2, and azacitidine) to treat severe graft-versus-host disease that didn't respond to steroids. Only 3 patients were enrolled before the trial was stopped early. The goal was to see if the treatment could control the immune reaction after a stem cell transplant.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cyclophosphamide, sirolimus, low-dose IL-2, and azacitidine
What this could lead to
If successful, this approach could offer a new way to control severe graft-versus-host disease when steroids fail.
What could go wrong
The trial was terminated early with only 3 participants, so results are very limited. The combination of drugs carries risks like infection and organ damage.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

3 people

The number who actually took part.

Start date

Aug 2011

Finished

Jul 2012

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 to 70 years

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: * Patients must have a documented clinical diagnosis of grade II-IV acute graft-versus- host disease defined as graft versus host disease (GVHD) occurring within the first 100 days of transplantation * Patients must be steroid-refractory defines as progression after 3 days of corticosteroid therapy or no response after 5 days of corticosteroid therapy. * Progression is defined as up-grading * No response is defined as no down-grading * Progression after 3 days requires patients to have received at least 2 mg/mg/day for a total of 6 mg/kg of methylprednisolone or its equivalent. * No response after 5 days requires patient to have received at least 2 mg/kg/d for a total of 10 mg/kg of methylprednisolone or its equivalent. * Patients with exacerbation of GVHD during steroid taper will require re-treatment with 2mg/kg/d of corticosteroids and will need to meet the criteria * Age 18-70 * Patients must have received an allogeneic hematopoietic stem cell transplant within 100 days of study enrollment. * Serum creatinine \< 2 mg/dL Exclusion Criteria: * Patients cannot have active central nervous system (CNS) disease. * Patients must not have received cyclophosphamide for GVHD prophylaxis * Patients must not have pneumonia requiring oxygen supplementation * Unable or unwilling to sign informed consent.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Acute-graft-versus-host disease are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

acute graft versus host disease graft versus host disease

As listed by the trial registrant

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

Graft versus host disease

Contacts and locations

Locations

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

More trials for these conditions

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