Pemigatinib in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphomas

NCT06300528 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: HCI181541
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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

Relapsed or Refractory B-cell Non-Hodgkin Lymphoma; Mantle Cell Lymphoma; Marginal Zone Lymphoma

Outcome Measures

Primary Outcomes (2)

• 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.

  8 months

• 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.

  8 months

Secondary Outcomes (4)

• Complete Response (CR) rate at Cycle 7 per IWG Response Criteria.

  8 months

• 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.

  4 years

• 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.

  4 years

• Overall survival (OS) as defined as the time from registration until death from any cause.

  4 years

Study Arms (1)

Treatment: All Patients

EXPERIMENTAL

The study will investigate the effectiveness of pemigatinib.

Drug: Pemigatinib

Interventions

Pemigatinib DRUG

Pemigatinib will be self-administered as a once-a-day oral treatment on a 28-day cycle.

Also known as: Pemazyre

Treatment: All Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects aged ≥ 18 years.
• ECOG Performance Status ≤ 2.
• Histologically confirmed MCL or MZL, including EMZL/MALT lymphoma, SMZL, and NMZL.
• Patients with gastric MALT lymphoma and those who are H. Pylori positive need to have failed a trial of H. Pylori eradication and are either ineligible, have refused, or have failed gastric radiation therapy.
• Have received at least two prior lines of systemic therapy and do not have FDA approved available therapies or have refused them.
• Prior autologous hematopoietic cell transplantation (auto-HCT) and CAR-T cell therapy are eligible.
• Patients with prior auto-HCT may be eligible if treatment completed after at least 3 months prior to first treatment
• Patients with CAR T-cell therapy may be eligible if treatment completed after at least 1 month prior to first treatment
• Subject must have an indication for systemic treatment.
• Radiographically measurable disease by computed tomography (CT) scan, defined as at least one lesion \>1.5 cm in size or assessable disease in the opinion of the investigator.
• Life expectancy \>3 months, in the opinion of the investigator.
• Adequate organ function as defined as:
• Hematologic:
• Absolute neutrophil count (ANC) ≥ 1000/mm3 (≥1.0 x 10\^9/L) independent of G-CSF support (i.e., no G-CSF within the past 3 days), unless there is documented bone marrow involvement or splenomegaly with ensuing cytopenia in which case ANC of 750 cells/mm3 (0.75 x 10\^9/L) is permissible. Also, there should be no evidence of myelodysplasia or hypoplastic bone marrow.
• Platelet count ≥ 75,000/mm3 (≥75 x 10\^9/L) independent of transfusion support (i.e., no transfusion within the past 3 days) unless there is documented bone marrow involvement in which case platelet count of 50,000 cells/mm3 (0.5 x 10\^9/L) is permissible. Patients must be responsive to transfusion support if given for thrombocytopenia and patients refractory to transfusion support are not eligible. Also, there should be no evidence of myelodysplasia or hypoplastic bone marrow.

You may not qualify if:

• 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.
• Prior systemic anti-cancer therapy or any investigational therapy within the timeframes listed below:
• Cytotoxic chemotherapy within 4 weeks prior to treatment.
• Monoclonal antibody within 3 weeks prior to treatment
• BTK inhibitor within 2 weeks prior to treatment. ---Note: The wash out interval is based on the last day of the prior therapy to the start of the study drug (C1D1).
• Prior radiotherapy within 4 weeks prior to the first dose of study treatment.
• Note: Subjects must have recovered from all radiation-related toxicities, not require corticosteroids, and not have radiation pneumonitis. A 2-week washout is permitted for palliative radiation to non-CNS disease.
• Major surgery 4 weeks prior to starting study drug or who have not fully recovered from major surgery.
• Active second malignancy which is expected to impact study participation, in the opinion of the investigator.
• Known CNS involvement.
• Current evidence of uncontrolled, significant intercurrent illness including, but not limited to, the following conditions:
• Cardiovascular disorders:
• Congestive heart failure New York Heart Association Class III or IV or serious cardiac arrhythmias.

Sponsors & Collaborators

• University of Utah: lead
• Incyte Corporation: collaborator

Study Sites (1)

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

MeSH Terms

Conditions

Recurrence; Lymphoma, B-Cell; Lymphoma, Mantle-Cell; Lymphoma, B-Cell, Marginal Zone

Interventions

pemigatinib

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Narendranath Epperla, MD, MS

  Huntsman Cancer Institute/ University of Utah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Kingsford

CONTACT

801-585-0115; rachel.kingsford@hci.utah.edu

Narendranath Epperla, MD, MS

CONTACT

8015850255; naren.epperla@hci.utah.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 8, 2024
• Study Start: October 3, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 1, 2030
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)