Safety and Efficacy of Iguratimod in the Treatment of Chronic GVHD

Launched by XUZHOU MEDICAL UNIVERSITY · Feb 2, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a medication called Iguratimod for treating chronic graft-versus-host disease (cGVHD). cGVHD is a condition that can occur after a stem cell transplant, where the new immune cells attack the body's own tissues. The trial aims to find out if Iguratimod, which is already used to treat other autoimmune diseases, can help patients with cGVHD. It’s important to note that the trial is currently looking for participants who are at least 18 years old, have had a stem cell transplant, and have been experiencing ongoing symptoms of cGVHD despite previous treatments.

If you decide to participate, you'll be closely monitored for any side effects while receiving Iguratimod. This trial is taking place at a single center and does not involve any blinding, meaning both participants and researchers will know who is receiving the medication. It’s an opportunity to contribute to important research that could help improve treatment options for others with similar conditions. If you have any questions or think you might be eligible, it’s a good idea to discuss this with your healthcare provider.

Gender

ALL

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.