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Pemigatinib After Chemotherapy for Newly Diagnosed Acute Myeloid Leukemia

This study is testing pemigatinib after standard chemotherapy (cytarabine and daunorubicin) for people with newly diagnosed acute myeloid leukemia (AML). Pemigatinib works by targeting FGFR (fibroblast growth factor receptor) activity, which may help leukemia cells grow. Researchers want to find the best dose of pemigatinib and see if it helps patients. To join, you must be at least 18 years old and willing to have a bone marrow biopsy/aspirate. The main goal is to see how many side effects occur at different doses of pemigatinib. This study plans to enroll 32 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It is a dose-escalation study, followed by a dose-expansion study, with a planned enrollment of 32 participants.
What's involved
You would undergo blood sample collection, bone marrow biopsy, and bone marrow aspirate procedures. You would also receive cytarabine and daunorubicin intravenously (IV).
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, incidence of dose limiting toxicities (DLTs), is measured from cycle 1 day 8, until 14 days after cycle 1 day 28 (up to 42 days).

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NCT04659616

Pemigatinib After Chemotherapy for the Treatment of Newly Diagnosed Acute Myeloid Leukemia

Recruiting
PHASE1Ages 18+InterventionalTreatment
OHSU Knight Cancer Institute
~32 participants
Updated 2026-07-14 on ClinicalTrials.gov
What's tested:Biospecimen CollectionBone Marrow AspirateBone Marrow BiopsyCytarabineDaunorubicinElectrocardiography

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of dose limiting toxicities (DLTs)
Measured over From cycle 1 day 8, until 14 days after cycle 1 day 28 (up to 42 days)

Conditions

Acute Myeloid Leukemia

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Where it's being run

2 sites across 2 states
Oregon1
Texas1

Study leadership

  • Elie Traer, MD PhD · PRINCIPAL_INVESTIGATOR · OHSU Knight Cancer Institute

Who to contact

OHSU Knight Cancer Institute Clinical Trials Information
[email protected]
503-494-1080
Email the study team

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Eligibility criteria

Inclusion

t(9;11)(p21.3;q23.3); MLLT3-KMT2A
Cytogenetic abnormalities not classified as favorable
t(6;9)(p23;q34.1); DEK-NUP214
t(v;11q23.3); KMT2A rearranged
t(9;22)(q34.1;q11.2); BCR-ABL1
inv(3)(q21.3q26.2) or t(3;3)(q21.3;q26.2); GATA2,MECOM(EVI1)
-5 or del(5q); -7; -17/abn(17p)
Complex karyotype - defined as three or more unrelated chromosome abnormalities in the absence of 1 of the WHO-designated recurring translocations or inversions, that is, t(8;21), inv(16) or t(16;16), t(9;11), t(v;11)(v;q23.3), t(6;9), inv(3) or t(3;3); AML with BCR-ABL1
Monosomal karyotype - defined by the presence of 1 single monosomy (excluding loss of X or Y) in association with at least 1 additional monosomy or structural chromosome abnormality (excluding core-binding factor AML)
Mutated RUNX1 (without favorable risk cytogenetics/mutations)
Mutated BCOR (without favorable risk cytogenetics/mutations)
Mutated EZH2 (without favorable risk cytogenetics/mutations)
Mutated ASXL1 (without favorable risk cytogenetics/mutations)
Mutated SF3B1 (without favorable risk cytogenetics/mutations)
Mutated SRSF2 (without favorable risk cytogenetics/mutations)
Mutated STAG2 (without favorable risk cytogenetics/mutations)
Mutated U2AF1, (without favorable risk cytogenetics/mutations)
Mutated ZRSR2 (without favorable risk cytogenetics/mutations)
Mutated TP53 (mono- or biallelic) at a variant allele fraction of at least 10%

Exclusion

Except for commonly observed calcifications in soft tissues such as the skin, kidney tendon, or vessels due to injury, disease, or aging in the absence of systemic mineral imbalance)
Individuals positive for hepatitis B core antibody who are receiving intravenous immunoglobulin (IVIg) are eligible if HepB PCR is negative
A screening QT interval by Fridericia's Correction Formula (QTcF) interval \> 480 ms will result in exclusion.
For participants with an intraventricular conduction delay (QRS interval \> 120 ms), the JTc interval may be used in place of the QTc with approval from Sponsor-Investigator. The JTc must be =\< 340 ms if JTc is used in place of the QTc.
Use of CYP3A4 inhibitors should be avoided but, if medically necessary, is permitted with a dose reduction of study drug
Use of moderate CYP3A4 inhibitors are permitted.
Based on the low overall bioavailability of topical ketoconazole, there are no restrictions on topical ketoconazole

What this trial measures

  • Incidence of dose limiting toxicities (DLTs)From cycle 1 day 8, until 14 days after cycle 1 day 28 (up to 42 days)

    Will be summarized using the proportion and exact binomial confidence interval. DLTs will be summarized at each dose level by severity and major organ site according to the Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0.