Actively Recruiting
Pemigatinib After Chemotherapy for the Treatment of Newly Diagnosed Acute Myeloid Leukemia
Led by OHSU Knight Cancer Institute · Updated on 2025-12-19
32
Participants Needed
2
Research Sites
311 weeks
Total Duration
On this page
Sponsors
O
OHSU Knight Cancer Institute
Lead Sponsor
I
Incyte Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase I trial identifies the best dose and clinical benefit of giving pemigatinib following standard induction chemotherapy in patients with newly diagnosed acute myeloid leukemia. Pemigatinib selectively inhibits FGFR (fibroblast growth factor receptor) activity, a receptor that may contribute to the growth of leukemia cells. The genetic changes responsible for activating the growth of leukemia cells can be unique to each patient and can change during the course of the disease. Chemotherapy drugs, such as cytarabine and daunorubicin work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
CONDITIONS
Official Title
Pemigatinib After Chemotherapy for the Treatment of Newly Diagnosed Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and willing to sign informed consent
- Age 18 years or older at time of consent
- Newly diagnosed AML with intermediate or adverse risk cytogenetics or mutations per European Leukemia Net guidelines
- No FLT3 mutations (wild-type FLT3)
- ECOG performance status 0-2
- Consent to bone marrow aspirate/biopsy before and during treatment
- Serum creatinine clearance at least 30 mL/min
- Serum phosphate and electrolytes within institutional normal limits or corrected before starting pemigatinib
- Total serum bilirubin and liver enzymes (AST/ALT) less than or equal to 3 times upper limit of normal
- Female participants of childbearing potential must use effective contraception during the study and for 6 months after last dose
- Male participants with partners of childbearing potential must use contraception during the study and for 3 months after last dose and avoid sperm donation
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia (APL) or AML M3 subtype
- AML with FLT3 mutations qualifying for standard treatment with midostaurin
- Favorable risk AML based on genetic markers
- Any cancer treatment within 2 weeks before planned induction except hydroxyurea or all-trans retinoic acid for suspected APL
- Prior treatment with selective FGFR inhibitors
- Known liver disease
- History of calcium/phosphate imbalance with ectopic calcification except common soft tissue calcifications
- Actively treated hypovitaminosis D with high doses
- Untreated HIV, active hepatitis B or C infections
- History of stroke or brain bleeding within 2 months
- Unable or unwilling to receive blood product infusions
- Inability to take oral medications
- Gastrointestinal conditions that affect drug absorption
- Known or current ectopic mineralization/calcification in certain organs
- Other active cancers with expected survival less than 1 year
- Active central nervous system involvement with AML
- Clinically significant blood clotting disorders
- Uncontrolled or significant heart disease
- Abnormal ECG or low heart function
- Active infection not controlled by treatment
- Use of certain prohibited medications affecting drug metabolism
- Allergy to pemigatinib or its ingredients
- Current eye corneal disorders
- Pregnancy or breastfeeding
- Any condition that would make participation unsafe or noncompliant
- Presence of FLT mutations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239
Actively Recruiting
2
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
O
OHSU Knight Cancer Institute Clinical Trials Information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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