A Study to Investigate Safety of Belumosudil in Participants Aged 12 Years and Above, With Chronic Graft-versus-host Disease (cGVHD)

Официальное название

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)

Обзор

This is an interventional phase IV clinical study which is single-arm study for assessing the safety of belumosudil in Indian patients who are12 years and older. Study details include: * The study duration will be up to 12 months per participant. * The treatment duration will be up to 24 weeks. * The number of visits will be 7.

Вмешательства

• Препарат Belumosudil
  Pharmaceutical form:Tablet-Route of administration:Oral

Первичные конечные точки

• Drug related Grade ≥ 3 treatment emergent adverse events (TEAE) [Срок оценки: From baseline to 24 weeks]

Вторичные конечные точки (12)

• Best overall Response (BoR) [Срок оценки: Baseline to end of study i.e. 12 months]
• Duration of Response (DOR) [Срок оценки: Baseline to end of study i.e. 12 months]
• Time to Response (TTR) [Срок оценки: Baseline to end of study i.e. 12 months]
• Response by organ system (including GSR) [Срок оценки: Baseline to end of study i.e. 12 months]
• Time taken for New Treatment (TTNT) or death [Срок оценки: Baseline to end of study i.e. 12 months]
• Failure-free survival (FFS) [Срок оценки: Baseline to end of study i.e. 12 months]
• Overall survival (OS) [Срок оценки: Baseline to end of study i.e. 12 months]
• Change in Corticosteroid dose. [Срок оценки: Baseline to end of study i.e. 12 months]
• Change in CNI dose [Срок оценки: Baseline to end of study i.e. 12 months]
• Symptomatic improvement from baseline during treatment based on modified Lee Symptom Scale [Срок оценки: Baseline to end of study i.e. 12 months]
• Pulmonary Function Test (PFT) [Срок оценки: Baseline to end of study i.e. 12 months]
• Number of participants with treatment-emergent adverse events [TEAEs], serious TEAEs, and adverse events of special interest (AESIs) [Срок оценки: Baseline to end of study i.e. 12 months]

Критерии участия

Критерии включения

• Male or female patients at least 12 years of age inclusive, at the time of signing the informed consent
• Participants who had an allogeneic hematopoietic cell transplantation (HCT)
• Previously received at least 2 prior lines of systemic therapy for cGVHD
• Received glucocorticoid therapy with a stable dose over the 2 weeks prior to screening
• Had persistent cGVHD manifestations and systemic therapy was indicated
• Karnofsky (if aged ≥ 16 years)/Lansky (if aged <16 years) Performance Score of ≥ 60
• Capable of giving signed informed consent as described in the protocol

Критерии исключения

Participants are excluded from the study if any of the following criteria apply:

• Absolute neutrophil count ≤1.5 X 109/L
• Platelet count ≤ 50 X 109/L
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 3 X upper limit of normal (ULN) (>5 × ULN if due to cGVHD)
• Total bilirubin ≥ 1.5 X ULN
• Glomerular filtration rate (GFR) ≤ 30 mL/min/1.73m3
• Positive hepatitis B surface antigen, or hepatitis C antibody or HIV antibody at screening
• FEV1 ≤39% or has lung score of 3

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07135973 · LPS18471

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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