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Antimetabolite

Pemigatinib for Acute Myeloid Leukemia

Phase 1
Recruiting
Led By Elie Traer
Research Sponsored by OHSU Knight Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
inv(3)(q21.3q26.2) or t(3;3)(q21.3;q26.2); GATA2,MECOM(EVI1)
Serum creatinine clearance >= 30 mL/min (as calculated by Cockcroft-Gault formula) (on or by day 8 of induction therapy, prior to starting pemigatinib)
Must not have
Diagnosis of acute promyelocytic leukemia (APL, or AML M3 subtype) per WHO classification
Inability to take oral medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from cycle 1 day 8, until 14 days after cycle 1 day 28 (up to 42 days)
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug, pemigatinib, to see if it can help treat acute myeloid leukemia (AML). AML is a type of cancer that starts in the bone marrow (the soft tissue inside bones where blood cells are made). Pemigatinib works by inhibiting (blocking) a protein called FGFR (fibroblast growth factor receptor). This protein is involved in the growth of leukemia cells.

Who is the study for?
Adults with newly diagnosed acute myeloid leukemia (AML) who have specific genetic changes linked to a poor prognosis can join this trial. They must be able to consent, perform daily activities with minimal help (ECOG 0-2), and have adequate organ function. Pregnant or breastfeeding women, those with favorable risk AML, recent cancer therapy except hydroxyurea, prior FGFR inhibitor use, certain infections or diseases affecting mineral balance are excluded.
What is being tested?
The trial is testing the effectiveness of pemigatinib following standard chemotherapy in treating AML. Pemigatinib targets FGFR activity which may drive leukemia growth. Participants will first receive cytarabine and daunorubicin chemotherapy before starting on pemigatinib at a dose determined safe and potentially beneficial.
What are the potential side effects?
Pemigatinib may cause side effects such as dry eyes or vision problems due to corneal disorders, abnormal blood tests reflecting liver issues, electrolyte imbalances leading to muscle cramps or weakness, and potential interactions that could affect heart rhythm seen on an ECG.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer has specific genetic changes known as inv(3) or t(3;3).
Select...
My kidney function, measured by creatinine clearance, is adequate.
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I can take care of myself and am up and about more than half of my waking hours.
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My condition involves specific genetic changes in my chromosomes.
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I have newly diagnosed AML with high-risk features according to WHO and ELN guidelines.
Select...
My cancer has a specific genetic change known as t(6;9)(p23;q34.1); DEK-NUP214.
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I have a specific type of newly diagnosed AML with an intermediate risk profile.
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My leukemia does not have common genetic changes but has multiple chromosome abnormalities.
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My cancer has a specific genetic change (KMT2A rearrangement).
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My cancer has the BCR-ABL1 gene mutation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with a specific type of leukemia called APL.
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I cannot take medicine by mouth.
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I have previously taken medication specifically targeting FGFR.
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I have a history of calcium or phosphate balance issues leading to soft tissue calcification.
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I have a liver condition.
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I have a diagnosed corneal disorder.
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My AML is considered favorable risk due to specific genetic features.
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My AML has a specific FLT3 mutation qualifying for standard treatment.
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I don't have major blood clotting issues before starting pemigatinib.
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My heart's pumping ability is below 45%.
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I have untreated HIV, active hepatitis C, or chronic hepatitis B.
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I have another cancer that is expected to affect my survival within a year.
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I am not currently taking any medications that are not allowed in the study.
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I am not taking any medications that are not allowed in the study.
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I do not want to receive blood product infusions.
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I have an infection that isn't getting better with antibiotics or antivirals.
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My acute myeloid leukemia has spread to my brain or spinal cord.
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I am being treated for severe vitamin D deficiency but can stop high-dose treatment before starting pemigatinib.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from cycle 1 day 8, until 14 days after cycle 1 day 28 (up to 42 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from cycle 1 day 8, until 14 days after cycle 1 day 28 (up to 42 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of dose limiting toxicities (DLTs)
Secondary study objectives
Incidence of non-treatment related adverse events (AEs)
Incidence of treatment-emergent adverse events (TEAEs)
Overall survival (OS)
+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%
Activated partial thromboplastin time prolonged
3%
Breast pain
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 (cytarabine, daunorubicin, pemigatinib)Experimental Treatment7 Interventions
INDUCTION: Patients receive cytarabine IV on days 1-7, daunorubicin IV on days 1-3, and pemigatinib PO QD on days 8-21 in the absence of disease progression or unacceptable toxicity. Patients with hematologic count recovery (assessed between days 25-42) after induction proceed to consolidation therapy. Patients undergo ECHO during screening and as clinically indicated on study. Patients undergo blood sample collection and bone marrow aspirate and biopsy during screening and cycle 11 day 21 on study. CONSOLIDATION: Patients receive high dose cytarabine IV BID on days 1, 3, and 5, and pemigatinib PO QD on days 8-21. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression of unacceptable toxicity. Patients undergo ECHO as clinically indicated and blood sample collection and bone marrow biopsy and aspirate at the end of consolidation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytarabine
2016
Completed Phase 3
~3330
Daunorubicin
2013
Completed Phase 4
~5040
Electrocardiography
2014
N/A
~220
Biospecimen Collection
2004
Completed Phase 3
~2020
Bone Marrow Aspirate
2015
Completed Phase 3
~40
Bone Marrow Biopsy
2021
Completed Phase 3
~230
Pemigatinib
2022
Completed Phase 2
~250

Find a Location

Who is running the clinical trial?

OHSU Knight Cancer InstituteLead Sponsor
235 Previous Clinical Trials
2,088,611 Total Patients Enrolled
Incyte CorporationIndustry Sponsor
389 Previous Clinical Trials
63,723 Total Patients Enrolled
Oregon Health and Science UniversityOTHER
1,001 Previous Clinical Trials
7,388,361 Total Patients Enrolled

Media Library

Cytarabine (Antimetabolite) Clinical Trial Eligibility Overview. Trial Name: NCT04659616 — Phase 1
Acute Myeloid Leukemia Research Study Groups: Treatment (cytarabine, daunorubicin, pemigatinib)
Acute Myeloid Leukemia Clinical Trial 2023: Cytarabine Highlights & Side Effects. Trial Name: NCT04659616 — Phase 1
Cytarabine (Antimetabolite) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04659616 — Phase 1
~5 spots leftby Aug 2025
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