RecruitingPhase 1NCT04659616

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

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


Sponsor

OHSU Knight Cancer Institute

Enrollment

32 participants

Start Date

Jan 14, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether adding pemigatinib — a targeted drug that blocks a pathway called FGFR — after standard induction chemotherapy can improve outcomes in adults newly diagnosed with intermediate- or high-risk acute myeloid leukemia (AML) without certain common genetic mutations. **You may be eligible if...** - You are 18 or older with newly diagnosed AML - Your AML does not have FLT3 mutations and is classified as intermediate or adverse risk by established leukemia guidelines - Your general health allows you to tolerate treatment (ECOG 0–2) - You are willing to consent to a bone marrow biopsy before starting standard chemotherapy **You may NOT be eligible if...** - You have favorable-risk AML or FLT3-mutated AML - Your AML has spread to the brain - You have received recent anti-cancer therapy without adequate recovery - You are pregnant or unwilling to use contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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 Institute

Portland, Oregon, United States

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04659616


Related Trials