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Clinical Trial 19800
Cancer Type: Malignant Hematology
Interventions:KD025
Study Type: Treatment
Phase of Study: Phase II
Investigators:
- Aleksandr Lazaryan
Call 813-745-6100 or 1-800-679-0775
Overview
Study 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)
Summary
Objective
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)
Inclusion Criteria
Adult male and female subjects at least 18 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
Exclusion Criteria
Received a systemic investigational cGVHD treatment within 28 days of study entry. Prior treatment is allowed with a washout of at least 5 half-lives or 28 days. (Note: Corticosteroids, calcineurin inhibitors, sirolimus, MMF, methotrexate and ECP are acceptable and subjects must have been on a stable dose / regimen of these for at least 2 weeks prior to screening). 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.
