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Not yet recruiting NCT07135973

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

Phase IV Interventional Chronic Graft Versus Host Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Belumosudil.
Who it may be relevant to
Registry conditions: Chronic Graft Versus Host Disease. Basic parameters: from 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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)

Overview

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.

Interventions

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

Primary outcome measures

  • Drug related Grade ≥ 3 treatment emergent adverse events (TEAE) [Time frame: From baseline to 24 weeks]
Secondary outcome measures (12)
  • Best overall Response (BoR) [Time frame: Baseline to end of study i.e. 12 months]
  • Duration of Response (DOR) [Time frame: Baseline to end of study i.e. 12 months]
  • Time to Response (TTR) [Time frame: Baseline to end of study i.e. 12 months]
  • Response by organ system (including GSR) [Time frame: Baseline to end of study i.e. 12 months]
  • Time taken for New Treatment (TTNT) or death [Time frame: Baseline to end of study i.e. 12 months]
  • Failure-free survival (FFS) [Time frame: Baseline to end of study i.e. 12 months]
  • Overall survival (OS) [Time frame: Baseline to end of study i.e. 12 months]
  • Change in Corticosteroid dose. [Time frame: Baseline to end of study i.e. 12 months]
  • Change in CNI dose [Time frame: Baseline to end of study i.e. 12 months]
  • Symptomatic improvement from baseline during treatment based on modified Lee Symptom Scale [Time frame: Baseline to end of study i.e. 12 months]
  • Pulmonary Function Test (PFT) [Time frame: 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) [Time frame: Baseline to end of study i.e. 12 months]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07135973 · LPS18471

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗