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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age12+
SponsorSanofi

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Belumosudil

Treatment groups

26 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators