The purpose of this clinical trial is to learn if the study drug pemigatinib is effective in treating patients with relapsed or refractory B-cell non-Hodgkin lymphomas.
Subjects aged ≥ 18 years.
ECOG Performance Status ≤ 2.
Histologically confirmed MCL or MZL, including EMZL/MALT lymphoma, SMZL, and NMZL.
Have received at least two prior lines of systemic therapy and do not have FDA approved available therapies or have refused them.
Prior receipt of FGFR inhibitor.
Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal (GI) absorption of the study drug.
Concurrent anticancer therapy except as listed in section 6.7.2 for prostate and breast cancer.
Cytotoxic chemotherapy within 4 weeks prior to treatment.
Single group
Pemigatinib
DrugPemigatinib will be self-administered as a once-a-day oral treatment on a 28-day cycle.
Overall Response Rate (ORR) at Cycle 7 per IWG Response Criteria in subjects with R/R MCL.
To assess the efficacy of pemigatinib in subjects with R/R MCL.
To determine the ORR at Cycle 7 per IWG Response Criteria in subjects with R/R MZL.
To assess the efficacy of pemigatinib in subjects with R/R MZL.
Complete Response (CR) rate at Cycle 7 per IWG Response Criteria.
To assess the CR rate at Cycle 7.
Duration of response (DoR), defined as the interval of time from the date of initial documented response (PR or better per IWG Response Criteria) to the time of progression from the best response, the start of a new therapy, or death from any cause.
To assess the DoR of the study population.
Progression-free survival (PFS) as defined as the time from study drug initiation to the time documented disease progression (as assessed by IWG Response Criteria), or death from any cause.
To assess median and 2 year PFS.
Overall survival (OS) as defined as the time from registration until death from any cause.
To assess median and 2 year OS in this study population.
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University of Utah
Lead sponsor
Incyte Corporation
Collaborator
