cGVHDPhase 1/2NCT06244628
Safety and Efficacy of Iguratimod in the Treatment of Chronic GVHD
A Phase 1/2 study testing Iguratimod in people with cGVHD, run by Xuzhou Medical University at 1 site in China.
Trial summary
This is a randomized, single-center phase 1/2 clinical trial without blinding. Iguratimod, as a rheumatoid arthritis medication, is used to treat autoimmune diseases such as Sjögren's syndrome. It has acceptable side effects, good clinical availability, and is cost-effective. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- cGVHD
- What is being tested?
- Iguratimod
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2024to 31 Dec 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients aged ≥18 years who have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT), regardless of gender.
- Those with persistent manifestations of chronic graft-versus-host disease (cGVHD) and suitable for systemic treatment.
- Previously received at least 1 but not more than 5 lines of systemic treatment for cGVHD.
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score: 0~1.
- Anticipated survival of more than 12 months.
Show all 9Show fewer
- General criteria:
- Serum pregnancy test negative for women of childbearing age during the screening period.
- Sexually active women of childbearing age participating in this study must agree to contraception during the trial and after the last dose of medication.
Who cannot join
- Patients who have received experimental treatment for systemic cGVHD within the 28 days prior to enrollment, which was effective and could completely alleviate immunosuppression.
- 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:
- Absolute neutrophil count (ANC) <1.5×10^9/L (excluding GVHD as the cause).
- Platelet count <50×10^9/L (excluding GVHD as the cause).
- Alanine aminotransferase (ALT) >3 times the upper limit of normal (ULN), aspartate aminotransferase (AST) >3×ULN (excluding GVHD as the cause).
Show all 16Show fewer
- Total bilirubin (TBIL) >1.5×ULN (excluding GVHD as the cause).
- Creatinine clearance CrCl <60 mL/min (Cockcroft-Gault formula).
- General criteria:
- Pregnant or lactating women.
- 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.
- Other circumstances in which the investigator deems it inappropriate to participate in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Kailin Xu
Xuzhou, Jiangsu, 221000
Kailin Xu, M.D., Ph.D., 15162166166, lihmd@163.com
About this study
Official title: Safety and Efficacy of Iguratimod in the Treatment of Chronic GVHD After Allogeneic Hematopoietic Stem Cell Transplantation
This is a randomized, single-center phase 1/2 clinical trial without blinding. Iguratimod, as a rheumatoid arthritis medication, is used to treat autoimmune diseases such as Sjögren's syndrome. It has acceptable side effects, good clinical availability, and is cost-effective. The investigators plan to recruit participants for a clinical trial to evaluate the efficacy and safety of Iguratimod in the treatment of chronic GVHD.
Read the detailed description
The investigators plan to recruit participants for a clinical trial to evaluate the efficacy and safety of Iguratimod in the treatment of chronic GVHD. Iguratimod possesses anti-inflammatory, anti-bone resorption, immune modulation, and anti-fibrotic effects. Considering that the pathogenesis of chronic GVHD involves inflammation, immune dysregulation, and fibrosis, Iguratimod is theoretically a potential treatment for cGVHD. In animal experiments, Iguratimod has demonstrated the ability to alleviate glandular inflammation, inhibit BAFF activity, reduce antibody production, and mitigate lung fibrosis. These findings provide a basis for Iguratimod's potential use in the treatment of cGVHD based on animal experimentation. In clinical practice, Iguratimod has been shown to alleviate dry mouth and dry eye symptoms in patients with Sjögren's syndrome. Since cGVHD shares similar symptoms of dry mouth and dry eye, with mechanisms resembling those in Sjögren's syndrome, it is reasonable to infer that Iguratimod used in the treatment of cGVHD patients could alleviate these symptoms and improve their quality of life. Similarly, organ damage in the lungs of cGVHD patients is mainly manifested as TGF-β activation-induced interstitial changes and pulmonary fibrosis. Studies suggest that adding Iguratimod to the treatment of patients with Sjögren's syndrome-induced lung interstitial changes and pulmonary fibrosis can inhibit TGF-β expression, thereby improving lung function and reducing the progression of pulmonary fibrosis. Therefore, the investigators hypothesize that Iguratimod is also effective against cGVHD-induced pulmonary fibrosis.
- Conditions
- cGVHD
- Being tested
- Iguratimod
- Keywords
- Iguratimod, cGVHD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IguratimodDrug
Oral administration of Iguratimod, 25mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| Iguratimod | Experimental | Oral administration of Iguratimod, 25mg twice daily. Receives: Drug: Iguratimod |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Adverse events assessed according to NCI-CTCAE v5.0
Measured: Baseline up to 60 days after taking Iguratimod
Secondary outcomes (4)
complete response (CR)
Assessment of CR at Month 1, 2, 3 and 4. According to the CHRONIC GVHD ACTIVITY ASSESSMENT - CLINICIAN recorded in NIH Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: IV. The 2014 Response Criteria Working Group report. (Biol Blood Marrow Transplant. 2015 Jun;21(6):984-99.)
Measured: Month 1, 2, 3 and 4
partial response (PR)
Assessment of CR at Month 1, 2, 3 and 4. According to the CHRONIC GVHD ACTIVITY ASSESSMENT - CLINICIAN recorded in NIH Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: IV. The 2014 Response Criteria Working Group report. (Biol Blood Marrow Transplant. 2015 Jun;21(6):984-99.)
Measured: Month 1, 2, 3 and 4
stable disease (SD)
Assessment of SD at Month 1, 2, 3 and 4. According to the CHRONIC GVHD ACTIVITY ASSESSMENT - CLINICIAN recorded in NIH Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: IV. The 2014 Response Criteria Working Group report. (Biol Blood Marrow Transplant. 2015 Jun;21(6):984-99.)
Measured: Month 1, 2, 3 and 4
progressed disease (PD)
Assessment of PD at Month 1, 2, 3 and 4. According to the CHRONIC GVHD ACTIVITY ASSESSMENT - CLINICIAN recorded in NIH Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: IV. The 2014 Response Criteria Working Group report. (Biol Blood Marrow Transplant. 2015 Jun;21(6):984-99.)
Measured: Month 1, 2, 3 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start10 Jan 2024
- Primary completion1 Jun 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for cGVHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kai Lin Xu，MD, Xuzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06244628
- Sponsor's protocol ID
- XYFY2023-KL371-01
- Status last verified
- Sep 2026
- First submitted
- 26 Jan 2024
- Last updated
- 30 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Iguratimod in the Treatment of Chronic GVHD After Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT06244628
- Acronym / sponsor ID
- XYFY2023-KL371-01
- Conditions
- cGVHD
- Keywords
- Iguratimod, cGVHD
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Xuzhou Medical UniversityUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 6 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, single-center phase 1/2 clinical trial without blinding. Iguratimod, as a rheumatoid arthritis medication, is used to treat autoimmune diseases such as Sjögren's syndrome. It has acceptable side effects, good clinical availability, and is cost-effective. The investigators plan to recruit participants for a clinical trial to evaluate the efficacy and safety of Iguratimod in the treatment of chronic GVHD.
Detailed description
The investigators plan to recruit participants for a clinical trial to evaluate the efficacy and safety of Iguratimod in the treatment of chronic GVHD. Iguratimod possesses anti-inflammatory, anti-bone resorption, immune modulation, and anti-fibrotic effects. Considering that the pathogenesis of chronic GVHD involves inflammation, immune dysregulation, and fibrosis, Iguratimod is theoretically a potential treatment for cGVHD. In animal experiments, Iguratimod has demonstrated the ability to alleviate glandular inflammation, inhibit BAFF activity, reduce antibody production, and mitigate lung fibrosis. These findings provide a basis for Iguratimod's potential use in the treatment of cGVHD based on animal experimentation. In clinical practice, Iguratimod has been shown to alleviate dry mouth and dry eye symptoms in patients with Sjögren's syndrome. Since cGVHD shares similar symptoms of dry mouth and dry eye, with mechanisms resembling those in Sjögren's syndrome, it is reasonable to infer that Iguratimod used in the treatment of cGVHD patients could alleviate these symptoms and improve their quality of life. Similarly, organ damage in the lungs of cGVHD patients is mainly manifested as TGF-β activation-induced interstitial changes and pulmonary fibrosis. Studies suggest that adding Iguratimod to the treatment of patients with Sjögren's syndrome-induced lung interstitial changes and pulmonary fibrosis can inhibit TGF-β expression, thereby improving lung function and reducing the progression of pulmonary fibrosis. Therefore, the investigators hypothesize that Iguratimod is also effective against cGVHD-induced pulmonary fibrosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iguratimod | Experimental | Drug: IguratimodOral administration of Iguratimod, 25mg twice daily. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Patients aged ≥18 years who have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT), regardless of gender.
- Those with persistent manifestations of chronic graft-versus-host disease (cGVHD) and suitable for systemic treatment.
- Previously received at least 1 but not more than 5 lines of systemic treatment for cGVHD.
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score: 0~1.
Key exclusion criteria (16 listed)
- Patients who have received experimental treatment for systemic cGVHD within the 28 days prior to enrollment, which was effective and could completely alleviate immunosuppression.
- 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.
- Absolute neutrophil count (ANC) <1.5×10^9/L (excluding GVHD as the cause).
- Platelet count <50×10^9/L (excluding GVHD as the cause).
- Alanine aminotransferase (ALT) >3 times the upper limit of normal (ULN), aspartate aminotransferase (AST) >3×ULN (excluding GVHD as the cause).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IguratimodOral administration of Iguratimod, 25mg twice daily | Drug | Iguratimod |
Primary outcome
Adverse events
Time frame: Baseline up to 60 days after taking Iguratimod
Adverse events assessed according to NCI-CTCAE v5.0
4 secondary outcomes
complete response (CR)
Time frame: Month 1, 2, 3 and 4
partial response (PR)
Time frame: Month 1, 2, 3 and 4
stable disease (SD)
Time frame: Month 1, 2, 3 and 4
progressed disease (PD)
Time frame: Month 1, 2, 3 and 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
Related trials for cGVHD
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Iguratimod in people with cGVHD, run by Xuzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kailin Xu, MD.,PD. (15162166166, lihmd@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: Baseline up to 60 days after taking Iguratimod). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.