Education and Training
Efficacy and Safety of KD025 in Subjects With cGVHD After At Least 2 Prior Lines of Systemic Therapy
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
Stanford is currently not accepting patients for this trial.
Intervention(s):
- drug: Belumosudil (KD025)
Eligibility
Inclusion Criteria:
1. Male and female subjects at least 12 years of age who have had allogenic hematopoietic
cell transplant (HCT).
2. Previously received at least 2 and not more than 5 lines of systemic therapy for cGVHD
3. Receiving glucocorticoid therapy with a stable dose over the 2 weeks prior to
screening
4. Have persistent cGVHD manifestations and systemic therapy is indicated
5. Karnofsky Performance Score of ≥ 60 (if aged 16 years or older); Lansky Performance
Score of ≥ 60 (if aged < 16 years)
6. Weight ≥ 40kg
Exclusion Criteria:
1. 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).
2. Histological relapse of the underlying cancer or post-transplant lymphoproliferative
disease at the time of screening.
3. Current treatment with ibrutinib. Prior treatment with ibrutinib is allowed with a
washout of at least 28 days prior to randomization.
Ages Eligible for Study
12 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Michelle Chin
650-721-4183
Not Recruiting