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

NCT03640481

TerminatedPhase 2

Sponsor: Kadmon, a Sanofi Company

Conditions: Chronic Graft-versus-host-disease

Interventions: Belumosudil (KD025)

Countries: United States

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

Eligibility overview

Sex: ALL

Age: 12 Years to —

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (35)
  • Phoenix, Arizona, United States
  • Tucson, Arizona, United States
  • Duarte, California, United States
  • Los Angeles, California, United States
  • San Francisco, California, United States
  • Stanford, California, United States
  • Denver, Colorado, United States
  • Miami, Florida, United States
  • Tampa, Florida, United States
  • Atlanta, Georgia, United States
  • Augusta, Georgia, United States
  • Chicago, Illinois, United States
  • Iowa City, Iowa, United States
  • Fairway, Kansas, United States
  • Bethesda, Maryland, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • Ann Arbor, Michigan, United States
  • Detroit, Michigan, United States
  • Minneapolis, Minnesota, United States
  • St Louis, Missouri, United States
  • Rochester, New York, United States
  • Winston-Salem, North Carolina, United States
  • Cleveland, Ohio, United States
  • Columbus, Ohio, United States
  • Portland, Oregon, United States
  • Pittsburgh, Pennsylvania, United States
  • Nashville, Tennessee, United States
  • Nashville, Tennessee, United States
  • Austin, Texas, United States
  • + 5 more on CT.gov