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

Stopped early · Phase 2

Conditions studied: Chronic Graft-versus-host-disease

In brief

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

Key facts

Study ID

NCT03640481

Run by

Kadmon, a Sanofi Company

People needed

159

Starts

2018-10-11

Expected to finish

2023-12-11

Last updated by the study team

2024-12-12

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male and female subjects at least 12 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 (if aged 16 years or older); Lansky Performance Score of ≥ 60 (if aged < 16 years)
• Weight ≥ 40kg

You may not qualify if…

• 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).
• 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.

Where it is running

• Phoenix Childrens Hospital Site Number : 154 — Phoenix, Arizona, United States
• University of Arizona - Cancer Center Site Number : 122 — Tucson, Arizona, United States
• City of Hope Medical Center Site Number : 050 — Duarte, California, United States
• University of California, Los Angeles (UCLA) - Medical Center Site Number : 104 — Los Angeles, California, United States
• University of California, San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center Site Number : 058 — San Francisco, California, United States
• Stanford Cancer Center Site Number : 108 — Stanford, California, United States
• Colorado Blood Cancer Institute Site Number : 098 — Denver, Colorado, United States
• University of Miami - Sylvester Cancer Center Site Number : 097 — Miami, Florida, United States
• Moffitt Site Number : 102 — Tampa, Florida, United States
• Emory University School of Medicine Site Number : 100 — Atlanta, Georgia, United States
• Augusta University Medical Center Site Number : 093 — Augusta, Georgia, United States
• University of Illinois at Chicago Site Number : 139 — Chicago, Illinois, United States
• University of Iowa Site Number : 126 — Iowa City, Iowa, United States
• University of Kansas Cancer Center Site Number : 105 — Fairway, Kansas, United States
• Center for Cancer Research National Cancer Institute Site Number : 107 — Bethesda, Maryland, United States
• Massachusetts General Hospital Site Number : 002 — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute Site Number : 004 — Boston, Massachusetts, United States
• CS Mott Children's Hospital Site Number : 157 — Ann Arbor, Michigan, United States
• Barbara Ann Karmanos Cancer Institute-4100 John R St Site Number : 094 — Detroit, Michigan, United States
• University of Minnesota Site Number : 051 — Minneapolis, Minnesota, United States
• Washington University School of Medicine Site Number : 125 — St Louis, Missouri, United States
• University of Rochester Site Number : 106 — Rochester, New York, United States
• Wake Forest Site Number : 123 — Winston-Salem, North Carolina, United States
• The Cleveland Clinic Foundation Site Number : 041 — Cleveland, Ohio, United States
• James Cancer Hospital & Wexner Medical Center at the Ohio State University Comprehensive Cancer Center Site Number : 103 — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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