Actively Recruiting
Pemigatinib in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphomas
Led by University of Utah · Updated on 2025-12-03
27
Participants Needed
1
Research Sites
269 weeks
Total Duration
On this page
Sponsors
U
University of Utah
Lead Sponsor
I
Incyte Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pemigatinib in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- ECOG Performance Status of 0, 1, or 2
- Histologically confirmed mantle cell lymphoma (MCL) or marginal zone lymphoma (MZL), including EMZL/MALT lymphoma, SMZL, and NMZL
- For gastric MALT lymphoma patients who are H. Pylori positive, must have failed eradication therapy and be ineligible, have refused, or failed gastric radiation therapy
- Received at least two prior lines of systemic therapy and have no FDA approved available therapies or have refused them
- Prior autologous hematopoietic cell transplantation completed at least 3 months before treatment or CAR-T cell therapy completed at least 1 month before treatment
- Indication for systemic treatment
- Radiographically measurable disease by CT scan with at least one lesion larger than 1.5 cm or assessable disease per investigator
- Life expectancy greater than 3 months as judged by investigator
- Adequate organ function including hematologic, hepatic, and renal parameters as specified
- For females, negative pregnancy test or post-menopausal status as defined by age and hormonal criteria or surgical sterilization
- Agreement to use effective contraception if of childbearing potential
- Ability to swallow oral tablets
- Recovery to baseline or Grade 2 or less CTCAE v5 toxicities from prior treatments unless clinically nonsignificant and stable
- Ability to read, understand, and provide informed consent
You will not qualify if you...
- Prior treatment with an FGFR inhibitor
- Active malabsorption syndrome or other condition affecting gastrointestinal absorption of the study drug
- Concurrent anticancer therapy except for specified cases in prostate and breast cancer
- Recent systemic anti-cancer therapy or investigational therapy within specified washout periods (cytotoxic chemotherapy within 4 weeks, monoclonal antibody within 3 weeks, BTK inhibitor within 2 weeks)
- Radiotherapy within 4 weeks prior to study drug start unless recovered and meeting specified conditions
- Major surgery within 4 weeks prior to starting study drug or incomplete recovery from major surgery
- Active second malignancy expected to affect study participation
- Known central nervous system involvement
- Uncontrolled significant illness including serious cardiac conditions, unstable angina, recent myocardial infarction, prolonged QTcF interval, low left ventricular ejection fraction, or other safety concerns
- Known HIV infection
- Active hepatitis B surface antigen positive or hepatitis C unless resolved with specific criteria
- History or current evidence of ectopic mineralization or calcification except certain exceptions
- Clinically significant corneal or retinal disorders confirmed by eye examination
- Use of potent CYP3A4 inhibitors or inducers or moderate inducers within 14 days or 5 half-lives before study drug
- History of hypovitaminosis D requiring high-dose supplementation
- Medical, psychiatric, cognitive, or other conditions compromising study compliance or informed consent
- Severe hypersensitivity to the investigational product or its components
- Taking prohibited medications without appropriate washout period before treatment start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
Research Team
R
Rachel Kingsford
CONTACT
N
Narendranath Epperla, MD, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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