A multi-center, single-arm phase IV clinical trial to evaluate the safety of Belumosudil in Indian participants, 12 years and above, with chronic graft-versus-host disease (cGVHD)

Sanofi Healthcare India Pvt Limited (SHIPL)5 个研究点分布在 1 个国家目标入组 26 人开始时间: 2025年12月11日最近更新: 2025年11月14日

试验速览

阶段: 4 期
状态: 尚未招募
发起方
入组人数: 26
试验地点: 5

研究概览研究设计入排标准研究者研究点记录与标识符相似试验

研究概览

简要总结

This is an interventional, multicenter, single group, prospective phase IV clinical study which is single-arm study for assessing the safety of belumosudil in Indian patients.

Participants who are at least 12 years of age and who have had an allogeneic hematopoietic cell transplantation (HCT) and have previously received at least 2 prior lines of systemic therapy for cGVHD will be screened for this study if they consent for the study.

Duration of study intervention

Total duration of study participation for each participant would be:

· Screening: 1 week

· Treatment duration: 24 weeks

Post treatment safety follow up: 12 months after the first dose of IMP

研究设计

研究类型: Interventional
分配方式: Na
盲法: None

入排标准

年龄范围: 12.00 Year(s) 至 99.00 Year(s)（—）
性别: All

入选标准

•I 01 Male or female patients at least 12 years of age inclusive, at the time of signing the informed consent Type of participant and disease characteristics I 02 Participants who had an allogeneic hematopoietic cell transplantation (HCT) Sex, contraceptive/barrier method and pregnancy testing requirements/breastfeeding I
•Male or Female -Female: A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies- --Not a woman of childbearing potential (WOCBP). OR --WOCBP who agrees to follow the contraceptive guidance which is highly effective (as described in Section XX) during the study intervention period and for at least 90 days after the last administration of study intervention.
•Male participants are eligible to participate if they agree during the study intervention period and for at least 90 days after the last administration of study intervention: --Either to be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent; OR must agree to use contraception/barrier (a male condom and an additional highly effective contraceptive method (as described in Section XX) when having sexual intercourse with a WOCBP who is not currently pregnant and capable of giving signed informed consent (including compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol) Informed Consent I
•Capable of giving signed informed consent as described in Appendix 1 of the protocol which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Other inclusion criteria I
•Previously received at least 2 prior lines of systemic therapy for cGVHD; I
•Received glucocorticoid therapy with a stable dose over the 2 weeks prior to screening. Note: Concomitant corticosteroids, calcineurin inhibitors, sirolimus, MMF, methotrexate, rituximab, and extracorporeal photopheresis (ECP) are acceptable. Systemic investigational GVHD treatments are not permitted; I
•Had persistent cGVHD manifestations and systemic therapy was indicated; I
•Karnofsky (if aged more than equal to 16 years)/Lansky (if aged more than equal to 16 years)/Lansky (if aged less than 16 years) Performance Score of more than equal to 60.

排除标准

•Participants are excluded from the study if any of the following criteria apply- Diagnostic assessments E
•Absolute neutrophil count less than equal to 1.5 X 109/L; E
•Platelet count less than equal to 50 X 109/L; E
•Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) more than equal to 3 X upper limit of normal (ULN) (more than 5 × ULN if due to cGVHD).; E
•Glomerular filtration rate (GFR) less than equal to 30 mL/min/1.73m3 E
•Positive hepatitis B surface antigen, or hepatitis C antibody or HIV antibody at screening E
•FEV1 less than equal to 39percent or has lung score of 3 Other exclusion criteria E
•Diagnosed with another malignancy (other than malignancy for which transplant was performed) within 3 years of enrolment E
•Current enrolment or past participation within the last 30 days before signing of informed consent in any other clinical study involving an investigational study treatment or any other type of medical research E
•Participation in a prior belumosudil clinical trial or any prior use of belumosudil E
•Has a history of or ongoing drug or alcohol abuse E
•Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study E
•Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized E
•Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures E
•Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals E 16.

研究者

发起方

Sanofi Healthcare India Pvt Limited (SHIPL)

申办方类型

Pharmaceutical industry-Global

责任方

Principal Investigator

研究点 (5)

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