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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up date of first response (>= immune complete remission) till date of documented relapse assessed up to 2 years from last dose of study intervention
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
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My cancer has specific genetic changes known as inv(3) or t(3;3).
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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.
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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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~date of first response (>= immune complete remission) till date of documented relapse assessed up to 2 years from last dose of study intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and date of first response (>= immune complete remission) till date of documented relapse assessed up to 2 years from last dose of study intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of dose limiting toxicities (DLTs)
Secondary outcome measures
Duration of remission (DOR)
Event-free survival (EFS)
Incidence of non-treatment related adverse events (AEs)
+5 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%
Insomnia
12%
Nasal dryness
12%
Gastrooesophageal reflux disease
12%
Pruritus
12%
Onychomadesis
11%
Rash
11%
Blood alkaline phosphatase increased
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%
Hyperbilirubinaemia
8%
Hypertension
8%
Abdominal distension
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%
Weight increased
4%
Pain
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%
Hypoalbuminaemia
2%
Rash maculo-papular
2%
Sepsis
2%
Electrocardiogram QT prolonged
2%
Hypocalcaemia
2%
Blood 1,25-dihydroxycholecalciferol increased
2%
Bacteraemia
2%
Failure to thrive
2%
Decubitus ulcer
2%
Pharyngitis
2%
Trichomegaly
2%
Palpitations
2%
Tachycardia
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%
Seizure
1%
Micturition urgency
1%
Hyperkalaemia
1%
Oesophageal varices haemorrhage
1%
Skin infection
1%
Biliary tract infection
1%
Intestinal obstruction
1%
Jaundice
1%
Thrombosis
1%
Septic shock
1%
Enterobacter bacteraemia
1%
Complication associated with device
1%
Prostate cancer
1%
Kidney infection
1%
Retinal detachment
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

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
Biospecimen Collection
2004
Completed Phase 2
~1730
Bone Marrow Aspirate
2015
Completed Phase 3
~40
Bone Marrow Biopsy
2021
Completed Phase 2
~10
Cytarabine
2016
Completed Phase 3
~3310
Daunorubicin
2013
Completed Phase 4
~4940
Electrocardiography
2014
N/A
~150
Pemigatinib
2022
Completed Phase 2
~220

Find a Location

Who is running the clinical trial?

OHSU Knight Cancer InstituteLead Sponsor
230 Previous Clinical Trials
2,090,694 Total Patients Enrolled
Incyte CorporationIndustry Sponsor
365 Previous Clinical Trials
55,157 Total Patients Enrolled
Oregon Health and Science UniversityOTHER
973 Previous Clinical Trials
7,385,780 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have any other investigations examined the efficacy of Pemigatinib?

"As of now, 272 clinical trials analysing Pemigatinib are operational with 66 experiments in Phase 3. Although Providence, Rhode island has the most documented studies examining this treatment, Pemigatinib is being assessed at 13002 total study sites worldwide."

Answered by AI

Has the Federal Drug Administration given its stamp of approval to Pemigatinib?

"With limited data available, our team at Power assigned the drug pemigatinib a rating of 1 on their safety scale. This is due to it still being in its Phase 1 trial stage."

Answered by AI

Are there opportunities for new participants in this experiment?

"According to clinicaltrials.gov, this research endeavor is recruiting participants as of the time of writing. The study was initially posted on January 14th 2021 and has since undergone edits culminating in its most current iteration which was last modified on July 8th 2022."

Answered by AI

What conditions has Pemigatinib been shown to ameliorate?

"Pemigatinib can be utilized to address acute myelocytic leukemia, blast phase chronic myelogenous leukemia, lymphoma and meningeal prophylaxis."

Answered by AI

What is the current enrollment rate for this experiment?

"Indeed, clinicaltrials.gov indicates that the trial is in search of participants as its last update was on July 8th 2022. Initially posted on January 14th 2021, this research endeavours to recruit 32 people at a single location."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Pemigatinib After Chemotherapy for the Treatment of Newly Diagnosed Acute Myeloid Leukemia
Elie Traer, MD PhD 2021. "Pemigatinib After Chemotherapy for the Treatment of Newly Diagnosed Acute Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04659616.
~9 spots leftby Aug 2025
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