OncoMatch/Clinical Trials/NCT04659616
Pemigatinib After Chemotherapy for the Treatment of Newly Diagnosed Acute Myeloid Leukemia
Is NCT04659616 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Cytarabine and Daunorubicin for acute myeloid leukemia.
Treatment: Cytarabine · Daunorubicin · Pemigatinib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: FLT3 wild-type
with wild-type FLT3
Required: RUNX1 mutation
Mutated RUNX1 (without favorable risk cytogenetics/mutations)
Required: BCOR mutation
Mutated BCOR (without favorable risk cytogenetics/mutations)
Required: EZH2 mutation
Mutated EZH2 (without favorable risk cytogenetics/mutations)
Required: ASXL1 mutation
Mutated ASXL1 (without favorable risk cytogenetics/mutations)
Required: SF3B1 mutation
Mutated SF3B1 (without favorable risk cytogenetics/mutations)
Required: SRSF2 mutation
Mutated SRSF2 (without favorable risk cytogenetics/mutations)
Required: STAG2 mutation
Mutated STAG2 (without favorable risk cytogenetics/mutations)
Required: U2AF1 mutation
Mutated U2AF1 (without favorable risk cytogenetics/mutations)
Required: ZRSR2 mutation
Mutated ZRSR2 (without favorable risk cytogenetics/mutations)
Required: TP53 mutation (variant allele fraction of at least 10%)
Mutated TP53 (mono- or biallelic) at a variant allele fraction of at least 10%
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: selective FGFR inhibitor
Prior receipt of a selective FGFR inhibitor
Cannot have received: cancer-directed therapy
Exception: hydroxyurea, empiric all-trans retinoic acid (ATRA) for suspected APL
Any cancer-directed therapy within 2 weeks prior to starting planned 7+3 induction regimen, with the exception of hydroxyurea, which is allowed to control white blood cell count, or empiric all-trans retinoic acid (ATRA) for suspected APL
Lab requirements
Kidney function
Serum creatinine clearance >= 30 mL/min (as calculated by Cockcroft-Gault formula) (on or by day 8 of induction therapy, prior to starting pemigatinib)
Liver function
Total serum bilirubin <= 3 x ULN; AST and/or ALT <= 3 x ULN (on or by day 8 of induction therapy, prior to starting pemigatinib)
Cardiac function
Left ventricular ejection fraction (LVEF) by echocardiogram < 45% prior to initiating pemigatinib [excluded]; QTcF > 480 ms will result in exclusion; JTc <= 340 ms if used in place of QTc
Serum creatinine clearance >= 30 mL/min; Total serum bilirubin <= 3 x ULN; AST and/or ALT <= 3 x ULN; LVEF by echocardiogram < 45% prior to initiating pemigatinib [excluded]; QTcF > 480 ms will result in exclusion; JTc <= 340 ms if used in place of QTc
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- OHSU Knight Cancer Institute · Portland, Oregon
- UT Southwestern/Simmons Cancer Center-Dallas · Dallas, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify