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Arthritis drug repurposed to fight stem cell transplant complication

NCT ID NCT06244628

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 phase 3 trial tests whether iguratimod, a drug already used for rheumatoid arthritis, can safely and effectively treat chronic graft-versus-host disease (cGVHD) in people who have had a stem cell transplant. The study will enroll 20 adults who have persistent cGVHD despite prior treatments. Participants will take iguratimod twice daily for 4 months, and researchers will track side effects and how well the disease responds.

What this could mean

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

Active substance
Iguratimod (a rheumatoid arthritis drug)
What this could lead to
If it works, this could offer a new, affordable treatment option for chronic GVHD, helping control the disease with manageable side effects.
What could go wrong
This is a small, single-center trial with only 20 participants, so results may not apply broadly. The drug is being repurposed, and its effectiveness for GVHD is not yet proven.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

Dec 2028

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 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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. Patients aged ≥18 years who have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT), regardless of gender. 2. Those with persistent manifestations of chronic graft-versus-host disease (cGVHD) and suitable for systemic treatment. 3. Previously received at least 1 but not more than 5 lines of systemic treatment for cGVHD. 4. Corticosteroid therapy dose stable for the two weeks before screening; or, if taking prednisone or an equivalent dose of other corticosteroids at a dose \>0.5mg/kg/day for four weeks, with ongoing cGVHD manifestations and no improvement; or, if two attempts to taper steroids to a lower dose have failed, and it is necessary to increase the prednisone dose to \>0.25mg/kg/day or an equivalent dose. 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score: 0\~1. 6. Anticipated survival of more than 12 months. General criteria: 7. Serum pregnancy test negative for women of childbearing age during the screening period. 8. Sexually active women of childbearing age participating in this study must agree to contraception during the trial and after the last dose of medication. Exclusion Criteria: 1. Patients who have received experimental treatment for systemic cGVHD within the 28 days prior to enrollment, which was effective and could completely alleviate immunosuppression. 2. Blood cancer relapse (according to the corresponding criteria for relapse of the primary blood cancer) or post-transplant lymphoproliferative disease at the time of screening. Laboratory tests: 3. Absolute neutrophil count (ANC) \<1.5×10\^9/L (excluding GVHD as the cause). 4. Platelet count \<50×10\^9/L (excluding GVHD as the cause). 5. Alanine aminotransferase (ALT) \>3 times the upper limit of normal (ULN), aspartate aminotransferase (AST) \>3×ULN (excluding GVHD as the cause). 6. Total bilirubin (TBIL) \>1.5×ULN (excluding GVHD as the cause). 7. Creatinine clearance CrCl \<60 mL/min (Cockcroft-Gault formula). General criteria: 8. Pregnant or lactating women. 9. History of serious illness or other evidence indicating a serious illness, or any other condition that the investigator believes may make the subject unsuitable for this study. * History of severe cardiovascular disease \[New York Heart Association (NYHA) functional class III or IV\], including but not limited to ventricular arrhythmias requiring clinical intervention, uncontrolled hypertension (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg); within 6 months prior to enrollment, there is unstable angina, acute coronary syndrome, congestive heart failure, stroke, or other cardiovascular events of class III or above; at screening, NYHA functional class ≥II or left ventricular ejection fraction (LVEF) \<50% on echocardiography. * Unable to take oral medications, with severe (NCI CTCAE v5.0 ≥ grade 3) chronic gastrointestinal dysfunction, the presence of malabsorption syndrome, or any other condition affecting gastrointestinal absorption. * History of clear neurological or psychiatric disorders (including epilepsy or dementia), currently suffering from psychiatric disorders, or judged by the investigator to be non-compliant and unsuitable for participation in the study. * History of other severe (NCI CTCAE v5.0 ≥ grade 3) systemic diseases, deemed unsuitable for participation in the clinical trial by the investigator. 10. Other circumstances in which the investigator deems it inappropriate to participate in this study.

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Kailin Xu

    RECRUITING

    Xuzhou, Jiangsu, 221000, China

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