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Relapsed or Refractory B-cell Non-Hodgkin LymphomaPhase 2NCT06300528

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

A Phase 2 study testing Pemigatinib in people with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma and Mantle Cell Lymphoma, run by University of Utah at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pemigatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteUnited States
Study dates
3 Oct 2025to Mar 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • Hemoglobin ≥ 8 g/dL independent of transfusion support (i.e., no transfusion within the past 3 days) unless there is documented bone marrow involvement or splenomegaly with ensuing cytopenia in which case hemoglobin of 7 g/dL is permissible. Patients must be responsive to transfusion support if given for anemia and patients refractory to transfusion support are not eligible. Also, there should be no evidence of myelodysplasia or hypoplastic bone marrow.
  • Hepatic:
  • Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN). or <2.5 x ULN with document liver involvement and/ or Gilbert's disease
  • AST(SGOT)/ALT(SGPT) ≤ 2.5 × institutional ULN ----Subjects with liver involvement will be allowed to enroll with AST and ALT levels ≤ 5 x ULN.
  • Renal:
  • ----Estimated creatinine clearance ≥ 30 mL/min by Cockcroft-Gault formula.
  • For female subjects: Negative pregnancy test or evidence of post-menopausal status. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
  • Women < 50 years of age:
  • ---Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and
  • ---Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution; or
  • ---Underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
  • Women ≥ 50 years of age:
  • Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or
  • Had radiation-induced menopause with last menses >1 year ago; or
  • Had chemotherapy-induced menopause with last menses >1 year ago; or
  • Underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).
  • Female subjects of childbearing potential and male subjects with a sexual partner of childbearing potential must agree to use a highly effective method of contraception as described in Section 5.3.1.
  • Ability to swallow oral tablets.
  • Recovery to baseline or ≤ Grade 2 CTCAE v5 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy per the treating investigator.
  • Patients or their legal representatives must be able to read, understand, and provide informed consent to participate in the trial.

Who cannot join

  • 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
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  • 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.
  • Unstable angina pectoris or acute coronary syndrome within the past 2 months prior to study enrolment
  • History of myocardial infarction (MI) within 3 months prior to enrollment.
  • QTcF prolongation defined as a QTcF > 470 ms
  • Correction of suspected drug induced QTcF prolongation can be attempted at the investigator's discretion and only if clinically safe to do so with either discontinuation of the offending drug or switch to another drug not known to be associated with QTcF prolongation.
  • Correction for underlying bundle branch block (BBB) allowed.
  • Note: Patients with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker.
  • Left ventricular ejection fraction < 40% in the 12 months prior to study enrollment
  • Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, [subjects may not receive the drug through a feeding tube], etc.)
  • Known HIV infection.
  • Active hepatitis B (known positive HBV surface antigen (HBsAg) result), or hepatitis C.
  • --Note: Subjects with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Subjects positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Subjects with SMZL who have chronic HCV will need to have undergone antiviral treatment to participate.
  • History and/or current evidence of ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, myocardia, or lung, excepting calcified lymph nodes and asymptomatic arterial or cartilage/tendon calcification.
  • Current evidence of clinically significant corneal or retinal disorder confirmed by ophthalmologic examination
  • Use of any potent CYP3A4 inhibitors or inducers or moderate CYP3A4 inducers within 14 days or 5 half-lives (whichever is longer) before the first dose of study drug. Moderate CYP3A4 inhibitors are not prohibited but should be avoided.
  • Subject with history of hypovitaminosis D requiring supraphysiologic dose (such as 50,000 IU of vitamin D3) to replenish the deficiency. Subjects receiving vitamin D food supplements are allowed.
  • Current evidence of clinically significant corneal (including but not limited to bullous/band keratopathy, corneal abrasion, inflammation/ulceration, and keratoconjunctivitis) or retinal disorder (including but not limited to macular/retinal degeneration, diabetic retinopathy, and retinal detachment) as confirmed by ophthalmologic examination.
  • Medical, psychiatric, cognitive, or other conditions that may compromise the subject's ability to understand the subject information, give informed consent, comply with the study protocol or complete the study.
  • Known prior severe hypersensitivity to investigational product (IP) or any component in its formulations (NCI CTCAE v5.0 Grade ≥ 3).
  • Subjects taking prohibited medications as described in Section 6.7.4. A washout period of prohibited medications for a period of at least five half-lives or as clinically indicated should occur before the start of treatment.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Huntsman Cancer Institute at University of Utah

    Salt Lake City, Utah, 84112

Other trials in United States

About this study

Official title: PERFORM: A Phase II Study of Pemigatinib in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphomas

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.

Being tested
Pemigatinib
Medical subject headings
Recurrence, Lymphoma, B-Cell, Lymphoma, Mantle-Cell, Lymphoma, B-Cell, Marginal Zone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PemigatinibDrug

    Also called Pemazyre

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

Study groups in NCT06300528
Study groupRoleWhat they receive
Treatment: All PatientsExperimentalThe study will investigate the effectiveness of pemigatinib.
Receives: Drug: Pemigatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 8 months

  2. 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.

    Measured: 8 months

Secondary outcomes (4)

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

    To assess the CR rate at Cycle 7.

    Measured: 8 months

  2. 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.

    Measured: 4 years

  3. 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.

    Measured: 4 years

  4. 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.

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2024
  2. Study start3 Oct 2025
  3. Primary completion16 Mar 2026
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06300528
Sponsor's protocol ID
HCI181541
Status last verified
Jul 2026
First submitted
1 Mar 2024
Last updated
9 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pemigatinib in people with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma and Mantle Cell Lymphoma, run by University of Utah at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 35 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) at Cycle 7 per IWG Response Criteria in subjects with R/R MCL. (time frame: 8 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06300528.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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