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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.