TerminatedPhase 2

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

Stopped: The sponsor has decided to prematurely terminate the study due to the challenges encountered in recruiting adolescent participants. This decision was made without any safety concerns.

United States159 participantsStarted 2018-10-11

Plain-language summary

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

Who can participate

Age range12 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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.

What they're measuring

Overall Response Rate (ORR)

Timeframe: From the date of randomization to the date of first documentation of progression or death due to any cause or data cut-off, whichever occurred first (maximum duration: up to 40.5 months for adult arms and 27.6 months for adolescent arms)

Trial details

NCT IDNCT03640481

SponsorKadmon, a Sanofi Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-12-11

Results submitted2024-09-26

View on ClinicalTrials.gov More Chronic Graft-versus-host-disease trials