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

ConditionAcute Myeloid Leukemia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorOHSU Knight Cancer Institute

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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 risk category is unknown, then it is okay to pre-screen patients for study. Adverse or intermediate risk needs to be confirmed prior to treatment with pemigatinib (during screening period) as outlined below

TREATMENT INCLUSION CRITERIA: Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Disqualifiers

PRE-SCREENING EXCLUSION CRITERIA: Diagnosis of acute promyelocytic leukemia (APL, or AML M3 subtype) per WHO classification

PRE-SCREENING EXCLUSION CRITERIA: AML with FLT3 mutations that qualify for standard of care treatment with 7+3 and midostaurin (e.g. FLT3 ITD or TKD with allelic ratio > 0.05)

PRE-SCREENING EXCLUSION CRITERIA: Favorable risk AML: inv(16), t(8;21), NPM1 mutations without FLT3-ITD, or in-frame mutations (mono- or biallelic) affecting the basic leucine zipper region of CEBPA

PRE-SCREENING EXCLUSION CRITERIA: 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

Trial design

Design model

Single group

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Bone Marrow Aspirate

    Procedure/Surgery

    Undergo bone marrow biopsy and aspirate

  • Bone Marrow Biopsy

    Procedure/Surgery

    Undergo bone marrow biopsy and aspiratie

  • Cytarabine

    Drug

    Given IV

  • Daunorubicin

    Drug

    Given IV

  • Electrocardiography

    Procedure/Surgery

    Undergo ECHO

  • Pemigatinib

    Drug

    Given PO

Treatment groups

32 Participants
are divided into 1 treatment group
Group A: Treatment (cytarabine, daunorubicin, pemigatinib)Experimental treatment 7 interventions

Trial outcomes

Primary outcomes

1

Incidence of dose limiting toxicities (DLTs)

Will be summarized using the proportion and exact binomial confidence interval. DLTs will be summarized at each dose level by severity and major organ site according to the Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0.

Time frame
From cycle 1 day 8, until 14 days after cycle 1 day 28 (up to 42 days)

Secondary outcomes

1

Rate of composite complete remission (cCR)

Time frame
From cycle 1 day 1, until blood cell count recovery after induction (day 25-42)
2

Duration of remission (DOR)

Time frame
Date of first response (>= immune complete remission) till date of documented relapse assessed up to 2 years from last dose of study intervention
3

Event-free survival (EFS)

Time frame
From cycle 1 day 1, until date of primary refractory disease, progression, relapse, or death from any cause, assessed up to 2 years from last dose of study intervention
4

Relapse-free survival (RFS)

Time frame
Date of first response (>= complete remission with incomplete blood count recovery [CRi]), until date of relapse or death from any cause, assessed up to 2 years from last dose of study intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

OHSU Knight Cancer Institute

Lead sponsor

Incyte Corporation

Collaborator

Oregon Health and Science University

Collaborator

Source ClinicalTrials.gov
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