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Kinase Inhibitor

Pemigatinib for Lymphoma

Phase 2
Waitlist Available
Led By Narendranath Epperla, MD, MS
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a drug called pemigatinib to see how well it works in treating patients with mantle cell lymphoma (MCL) or marginal zone lymphoma (MZL) that has

Who is the study for?
This trial is for patients with specific types of lymphoma—Mantle Cell Lymphoma (MCL) or Marginal Zone Lymphoma (MZL)—that have either returned after treatment or haven't responded to previous treatments. Detailed eligibility criteria are not provided.
What is being tested?
The trial is testing the effectiveness of pemigatinib, a drug that may inhibit cancer cell growth by blocking certain enzymes. It includes collecting biospecimens, bone marrow aspirations and biopsies, as well as CT and PET scans to monitor progress.
What are the potential side effects?
Specific side effects for pemigatinib are not listed here, but such drugs can commonly cause fatigue, nausea, diarrhea, liver issues, and changes in blood counts which could lead to increased infection risk.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall Response Rate (ORR) at Cycle 7 per IWG Response Criteria in subjects with R/R MCL.
To determine the ORR at Cycle 7 per IWG Response Criteria in subjects with R/R MZL.
Secondary study objectives
Complete Response (CR) rate at Cycle 7 per IWG Response Criteria.
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.
Overall survival (OS) as defined as the time from registration until death from any cause.
+1 more

Side effects data

From 2022 Phase 2 trial • 147 Patients • NCT02924376
59%
Alopecia
56%
Hyperphosphataemia
54%
Diarrhoea
46%
Fatigue
43%
Stomatitis
43%
Constipation
42%
Nausea
42%
Dysgeusia
39%
Dry mouth
35%
Dry eye
34%
Arthralgia
32%
Vomiting
31%
Decreased appetite
28%
Dry skin
26%
Hypophosphataemia
25%
Back pain
24%
Pain in extremity
21%
Palmar-plantar erythrodysaesthesia syndrome
20%
Abdominal pain
19%
Headache
19%
Urinary tract infection
19%
Weight decreased
18%
Dizziness
18%
Epistaxis
15%
Oedema peripheral
15%
Hypercalcaemia
15%
Anaemia
15%
Dehydration
14%
Myalgia
14%
Asthenia
13%
Dyspepsia
12%
Gastrooesophageal reflux disease
12%
Insomnia
12%
Nasal dryness
12%
Pruritus
12%
Onychomadesis
11%
Blood alkaline phosphatase increased
11%
Rash
11%
Nail discolouration
11%
Alanine aminotransferase increased
10%
Muscle spasms
10%
Pyrexia
10%
Abdominal pain upper
10%
Nail dystrophy
10%
Oropharyngeal pain
10%
Trichiasis
9%
Dyspnoea
9%
Vitamin D deficiency
9%
Onycholysis
9%
Cough
8%
Abdominal distension
8%
Hyperbilirubinaemia
8%
Hypertension
8%
Hypokalaemia
8%
Paronychia
8%
Onychoclasis
8%
Blood creatinine increased
8%
Aspartate aminotransferase increased
7%
Growth of eyelashes
7%
Fall
7%
Punctate keratitis
7%
Erythema
7%
Nasal congestion
7%
Platelet count decreased
6%
Conjunctivitis
6%
Lacrimation increased
6%
Nail disorder
6%
Nasopharyngitis
6%
Neuropathy peripheral
6%
Skin exfoliation
6%
Taste disorder
6%
Upper respiratory tract infection
6%
Cataract
6%
Eye pain
6%
Chills
6%
Blood bilirubin increased
6%
Depression
6%
Hyponatraemia
6%
Ocular hyperaemia
6%
Influenza like illness
5%
Dysphagia
5%
Vitreous floaters
5%
Cystitis
5%
Cholangitis
5%
Flank pain
5%
Hypotension
5%
Acute kidney injury
5%
Muscular weakness
5%
Neck pain
5%
Oral candidiasis
4%
Hyperuricaemia
4%
Pain
4%
Weight increased
4%
Ascites
4%
Skin fissures
4%
Lymphocyte count decreased
4%
Keratitis
3%
Breast pain
3%
Activated partial thromboplastin time prolonged
3%
Dyspnoea exertional
3%
Tinnitus
3%
Blood parathyroid hormone decreased
3%
Pollakiuria
3%
Bronchitis
3%
Cholangitis infective
3%
Non-cardiac chest pain
2%
Decubitus ulcer
2%
Sepsis
2%
Blood 1,25-dihydroxycholecalciferol increased
2%
Electrocardiogram QT prolonged
2%
Hypoalbuminaemia
2%
Failure to thrive
2%
Bacteraemia
2%
Hypocalcaemia
2%
Palpitations
2%
Pharyngitis
2%
Rash maculo-papular
2%
Tachycardia
2%
Trichomegaly
2%
Dysuria
2%
Hyperglycaemia
2%
Dysphonia
2%
Device occlusion
2%
Small intestinal obstruction
2%
Blood 1,25-dihydroxycholecalciferol decreased
2%
Chronic kidney disease
2%
Biliary obstruction
2%
Pleural effusion
2%
Pneumonia
2%
Hypercholesterolaemia
1%
Prostate cancer
1%
Skin infection
1%
Retinal detachment
1%
Septic shock
1%
Thrombosis
1%
Biliary tract infection
1%
Complication associated with device
1%
Enterobacter bacteraemia
1%
Intestinal obstruction
1%
Hyperkalaemia
1%
Jaundice
1%
Kidney infection
1%
Oesophageal varices haemorrhage
1%
Micturition urgency
1%
Seizure
1%
Pseudomonal bacteraemia
1%
Varices oesophageal
1%
Oral herpes
1%
Clostridium difficile infection
1%
Device leakage
1%
Gynaecomastia
1%
Somnolence
1%
Catheter site infection
1%
Gastrointestinal haemorrhage
1%
Haematemesis
1%
Hydronephrosis
1%
Optic ischaemic neuropathy
1%
Pneumonitis
1%
Transaminases increased
1%
C-reactive protein increased
1%
Cancer pain
1%
Candida infection
1%
Confusional state
1%
Herpes zoster
1%
Musculoskeletal pain
1%
Psoriasis
1%
Blood chloride decreased
1%
Cerebrovascular accident
1%
Malignant biliary obstruction
1%
Melaena
1%
Paraplegia
1%
Pneumonia aspiration
1%
Pneumonia pneumococcal
1%
Syncope
1%
Haemorrhoids
1%
Sinus pain
1%
Urinary tract pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort A: FGFR2 Rearrangements or Fusions
Cohort B: FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions
Cohort C: Negative for FGF/FGFR Alterations
Other
Total

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment: All PatientsExperimental Treatment1 Intervention
The study will investigate the effectiveness of pemigatinib.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pemigatinib
2022
Completed Phase 2
~300

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,147 Previous Clinical Trials
1,699,053 Total Patients Enrolled
Incyte CorporationIndustry Sponsor
393 Previous Clinical Trials
63,817 Total Patients Enrolled
Narendranath EpperlaLead Sponsor
2 Previous Clinical Trials
23 Total Patients Enrolled
Narendranath Epperla, MD, MSPrincipal InvestigatorOhio State University Comprehensive Cancer Center
2 Previous Clinical Trials
43 Total Patients Enrolled
~18 spots leftby Nov 2026
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