Arthritis drug repurposed to fight stem cell transplant complication
NCT ID NCT06244628
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2024
- Expected to finish
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Dec 2028
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 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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: 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Kailin Xu
RECRUITINGXuzhou, Jiangsu, 221000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a skin biopsy reveal how axatilimab fights scarring in chronic GVHD?
- New antibody cocktail targets stubborn liver disease after stem cell transplants
- New drug combo aims to tame transplant complication
- New combo therapy aims to tame chronic GVHD
- New drug gecacitinib tested for tough transplant complication