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Trial Title:
Pemigatinib in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphomas
NCT ID:
NCT06300528
Condition:
Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Pemigatinib
Description:
Pemigatinib will be self-administered as a once-a-day oral treatment on a 28-day cycle.
Arm group label:
Treatment: All Patients
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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.
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Huntsman Cancer Institute at University of Utah
Address:
City:
Salt Lake City
Zip:
84112
Country:
United States
Contact:
Last name:
Catherine Cromar
Contact backup:
Phone:
801-213-5652
Email:
catherine.cromar@hci.utah.edu
Start date:
November 2024
Completion date:
December 2030
Lead sponsor:
Agency:
University of Utah
Agency class:
Other
Collaborator:
Agency:
Incyte Corporation
Agency class:
Industry
Source:
University of Utah
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06300528