Efficacy and Safety of KD025 in Subjects With cGVHD After At Least 2 Prior Lines of Systemic Therapy

Not Recruiting

Trial ID: NCT03640481,,

Purpose

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

Official Title

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 (The ROCKstar Study)

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.

Intervention(s):

drug: Belumosudil (KD025)

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Michelle Chin
650-721-4183

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