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

Part of paid clinical trials in Portland, Oregon.

Sponsor
OHSU Knight Cancer Institute
Study ID
NCT04659616
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Bone Marrow Aspirate — PROCEDURE
    Undergo bone marrow biopsy and aspirate
  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow biopsy and aspiratie
  • Cytarabine — DRUG
    Given IV
  • Daunorubicin — DRUG
    Given IV
  • Electrocardiography — PROCEDURE
    Undergo ECHO
  • Pemigatinib — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Jan 14, 2021
Status verified
Dec 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (cytarabine, daunorubicin, pemigatinib)
    INDUCTION: Patients receive cytarabine IV on days 1-7, daunorubicin IV on days 1-3, and pemigatinib PO QD on days 8-21 in the absence of disease progression or unacceptable toxicity. Patients with hematologic count recovery (assessed between days 25-42) after induction proceed to consolidation therapy. Patients undergo ECHO during screening and as clinically indicated on study. Patients undergo blood sample collection and bone marrow aspirate and biopsy during screening and cycle 11 day 21 on study. CONSOLIDATION: Patients receive high dose cytarabine IV BID on days 1, 3, and 5 of each cycle, and pemigatinib PO QD on days 8-21 of each cycle. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression of unacceptable toxicity. Patients undergo ECHO as clinically indicated and blood sample collection and bone marrow biopsy and aspirate at the end of consolidation.

Primary Outcome Measure

Incidence of dose limiting toxicities (DLTs) [ Time Frame: From cycle 1 day 8, until 14 days after cycle 1 day 28 (up to 42 days) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
OHSU Knight Cancer InstitutePortlandOregon97239
Elie Traer, MD PhD
[email protected]
503-494-3553
Elie Traer, MD PhD (PRINCIPAL_INVESTIGATOR)
UT Southwestern/Simmons Cancer Center-DallasDallasTexas75390
Yazan Madanat, MD
[email protected]
Yazan Madanat, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Portland, OR

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
OHSU Knight Cancer Institute· Portland, ORUT Southwestern/Simmons Cancer Center-Dallas· Dallas, TX

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