Using Iguratimod to treat chronic graft-versus-host disease

Safety and Efficacy of Iguratimod in the Treatment of Chronic GVHD After Allogeneic Hematopoietic Stem Cell Transplantation

This study is testing if Iguratimod, a medication usually for rheumatoid arthritis, can help people with chronic graft-versus-host disease feel better and improve their lung function.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Xuzhou Medical University (Academic / other)
• Drugs / interventions: prednisone
• Locations: 1 site (Xuzhou, Jiangsu)
• Trial ID: NCT06244628 on ClinicalTrials.gov

What this trial studies

This phase 3 clinical trial evaluates the safety and efficacy of Iguratimod, a medication typically used for rheumatoid arthritis, in patients with chronic graft-versus-host disease (cGVHD). The study is randomized and single-center, focusing on participants who have undergone allogeneic hematopoietic stem cell transplantation and have persistent cGVHD symptoms. Iguratimod is believed to have anti-inflammatory and immune-modulating effects that could alleviate symptoms similar to those seen in Sjögren's syndrome, such as dry mouth and dry eyes. The trial aims to determine if Iguratimod can improve quality of life and lung function in these patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have undergone allogeneic hematopoietic stem cell transplantation and have persistent cGVHD symptoms.

Not a fit: Patients who have not undergone stem cell transplantation or those with severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from chronic GVHD by alleviating debilitating symptoms.

How similar studies have performed: While Iguratimod has shown promise in treating Sjögren's syndrome, its application in cGVHD is novel and has not been extensively tested in previous studies.

Eligibility criteria

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.

Where this trial is running

Xuzhou, Jiangsu

• Kailin Xu — Xuzhou, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Kailin Xu, MD.,PD.

Conditions cGVHD; Iguratimod