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Efficacy and Safety of KD025 in Subjects With cGVHD After At Least 2 Prior Lines of Systemic Therapy
Trial Status: administratively complete
This is a Phase 2, randomized, multicenter study to evaluate the efficacy and safety of
KD025 in subjects with Chronic Graft Versus Host Disease (cGVHD) after at least 2 prior
lines of systemic therapy
Inclusion Criteria
Male and female subjects at least 12 years of age who have had allogenic hematopoietic cell transplant (HCT).
Previously received at least 2 and not more than 5 lines of systemic therapy for cGVHD
Receiving glucocorticoid therapy with a stable dose over the 2 weeks prior to screening
Have persistent cGVHD manifestations and systemic therapy is indicated
Karnofsky Performance Score of ≥ 60 (if aged 16 years or older); Lansky Performance Score of ≥ 60 (if aged < 16 years)
Weight ≥ 40kg
Exclusion Criteria
Subjects has not been on a stable dose / regimen of systemic cGVHD treatments for at least 2 weeks prior to screening. (Note: Concomitant corticosteroids, calcineurin inhibitors, sirolimus, MMF, methotrexate, rituximab, and extracorporeal photophoresis (ECP) are acceptable. Systemic investigational GVHD treatments are not permitted).
Histological relapse of the underlying cancer or post-transplant lymphoproliferative disease at the time of screening.
Current treatment with ibrutinib. Prior treatment with ibrutinib is allowed with a washout of at least 28 days prior to randomization.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03640481.
Locations matching your search criteria
United States
Georgia
Atlanta
Emory University Hospital/Winship Cancer Institute
Status: Active
Name Not Available
Michigan
Ann Arbor
University of Michigan Rogel Cancer Center
Status: Approved
Name Not Available
Pennsylvania
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: Active
Name Not Available
Phase 2, open label, randomized, multicenter study in subjects with cGVHD who have
previously been treated with at least 2 prior lines of systemic therapy. Approximately
166 subjects with active cGVHD will be randomized (1:1) to receive treatment with one of
two belumosudil (formerly known as KD025) regimens:
- Arm A: belumosudil 200 mg QD
- Arm B: belumosudil 200 mg BID
With Amendment 2, the sample size was increased from approximately 126 subjects, with
additional subjects to be enrolled as follows:
- 20 adolescents
- 20 adults into a site-specific Companion Study to collect biospecimens
These additional subjects will also be randomized (1:1) to Arm A or Arm B.
Any adolescent taking a proton pump inhibitor (PPI) or a strong CYP3A4 inducer will begin
Cycle 1 Day 1 at the escalated dose of belumosudil 200 mg BID.
Randomization will be stratified according to prior cGVHD treatment with ibrutinib (Yes /
No) and severe cGVHD at baseline (Yes / No). Subjects may receive treatment in 28-day
treatment cycles until clinically significant progression of cGVHD. Subjects who have not
achieved a response after 12 cycles of belumosudil should be withdrawn if in the
Investigator's judgment there is no evidence of clinical benefit. Subjects will undergo
evaluations as outlined in the Study Assessments table (Appendix A). The primary endpoint
is the overall response rate (ORR) with responses as defined by the 2014 National
Institute of Health (NIH) Consensus Development Project on clinical trials in cGVHD.
