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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

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

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
Not Available
Phase II
Adults
Not Available
Not Available
Jagasia, Madan
National
Vanderbilt University
12-06-2018
Treatment
VICCBMT18121
NCT03640481

Eligibility

18 Years
BOTH
NO
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.

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