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Could a cheap arthritis drug replace steroids for transplant complications?

NCT ID NCT04932564

Disease control Sponsor: Tata Memorial Centre 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested leflunomide, a drug used for rheumatoid arthritis, as a first-line treatment for musculoskeletal graft-versus-host disease (GVHD), a complication of bone marrow transplants where donor cells attack the patient's muscles and joints. The goal was to see if leflunomide could be a safer alternative to steroids, which often cause severe side effects. Only 1 person enrolled before the study was terminated, so no firm conclusions can be drawn.

What this could mean

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

Active substance
Leflunomide
What this could lead to
If successful, leflunomide could offer a safer, steroid-free treatment option for musculoskeletal GVHD, reducing side effects and costs.
What could go wrong
This was a very small pilot study with only 1 participant and was terminated early, so results are not reliable. The drug may not work as well in larger trials.

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

1 person

The number who actually took part.

Started

Sep 2023

Finished

Jun 2024

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

0 to 65 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: 1. Willing to give written informed consent 2. Patients diagnosed with musculoskeletal mGvHD based on 2014 NIH consensus criteria (with diagnosis confirmed by biopsy only if clinically required). 3. Willing and able to comply with all study requirements, including treatment, and periodic assessments. Exclusion Criteria: 1. Patients with known hypersensitivity to leflunomide especially previous Steven Johnson syndrome, toxic epidermal necrolysis after leflunomide. 2. Pregnant females 3. Patients with musculoskeletal manifestations explained by other potential causes ( (drugs, trauma, etc). 4. Patients with calculated glomerular filtration rate (GFR) \<30ml/min at the time of screening.

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Conditions

The condition(s) this trial relates to.

Bronchiolitis Obliterans Syndrome chronic graft versus host disease graft versus host disease musculoskeletal system disorder

As listed by the trial registrant

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

GVHD, chronic Musculoskeletal disease other

Contacts and locations

Locations

  • Tata Memorial Centre, Advanced Centre for Treatment, Research and Education in Cancer

    Navi Mumbai, Maharashtra, 410210, India

More trials for these conditions

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