A Multicenter, Phase 1, Open-Label Study of the FGFR Inhibitor Pemigatinib (INCB054828) Administered After Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia (AML) With Adverse or Intermediate Risk Cytogenetics
OHSU Knight Cancer Institute
Summary
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.
Description
PRIMARY OBJECTIVE: I. To determine the maximum tolerated dose of pemigatinib (INC054828) following standard of care induction chemotherapy. SECONDARY OBJECTIVES: I. To assess preliminary efficacy associated with study intervention. II. To assess the safety profile of the study intervention. III. To evaluate time-to- marrow recovery between cycles of pemigatinib. EXPLORATORY OBJECTIVES: I. Assess minimal residual disease (MRD) by fluorescent in situ hybridization (FISH), reverse transcriptase-polymerase chain reaction (RT-PCR), and/or next-generation sequencing of acute myeloid leukemia (A…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * PRE-SCREENING INCLUSION CRITERIA: Ability to understand and the willingness to sign a written informed consent document * PRE-SCREENING INCLUSION CRITERIA: Age \>= 18 years at time of informed consent. Both men and women of all races and ethnic groups will be included * PRE-SCREENING INCLUSION CRITERIA: Participants must consent to a bone marrow aspirate/biopsy that will be collected prior to start of planned 7+3 induction therapy. Patients with known favorable risk AML (2022 European Leukemia Net \[ELN\] Guidelines) or FLT3 mutations should not be pre-screened. If the r…
Interventions
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureBone Marrow Aspirate
Undergo bone marrow biopsy and aspirate
- ProcedureBone Marrow Biopsy
Undergo bone marrow biopsy and aspiratie
- DrugCytarabine
Given IV
- DrugDaunorubicin
Given IV
- ProcedureElectrocardiography
Undergo ECHO
- DrugPemigatinib
Given PO
Locations (2)
- OHSU Knight Cancer InstitutePortland, Oregon
- UT Southwestern/Simmons Cancer Center-DallasDallas, Texas