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RECRUITING
NCT04659616
PHASE1

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

Sponsor: OHSU Knight Cancer Institute

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2021-01-14

Completion Date

2026-12-31

Last Updated

2025-12-19

Healthy Volunteers

No

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Bone Marrow Aspirate

Undergo bone marrow biopsy and aspirate

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy and aspiratie

DRUG

Cytarabine

Given IV

DRUG

Daunorubicin

Given IV

PROCEDURE

Electrocardiography

Undergo ECHO

DRUG

Pemigatinib

Given PO

Locations (2)

OHSU Knight Cancer Institute

Portland, Oregon, United States

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, United States