Health TrialsbyHealthPanel

Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia

ConditionsAMLAML With Mutated NPM1Hematologic MalignancyKMT2ArNPM1 MutationMLL RearrangementLeukemiaAcute Myeloid LeukemiaLeukemia, MyeloidLeukemia, Myeloid, AcuteAcute LeukemiaNeoplasms by Histologic Type
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorKura Oncology, Inc.

About this trial

The safety, tolerability, and antileukemic response of ziftomenib in combination with standard of care treatments for patients with relapsed/refractory acute myeloid leukemia will be examined with the following agents: FLAG-IDA, low-dose cytarabine, and gilteritinib.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Has been diagnosed with relapsed/refractory AML.

Has a documented NPM1 mutation or KMT2A rearrangement.

Has a documented FLT3 mutation (cA-3 only).

Has an Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2.

Disqualifiers

Has a diagnosis of acute promyelocytic leukemia or blast chronic myeloid leukemia.

Has clinically active central nervous system leukemia.

Has an active and uncontrolled infection.

Has a mean corrected QT interval (QTcF) > 480ms.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ziftomenib

    Drug

    Oral administration

  • Fludarabine

    Drug

    Intravenous infusion

  • Idarubicin

    Drug

    Intravenous infusion

  • Cytarabine

    Drug

    Intravenous Infusion

  • Gilteritinib

    Drug

    Oral administration

  • Granulocyte colony-stimulating factor

    Biological/Vaccine

    Subcutaneous injection

Treatment groups

171 Participants
are divided into 2 treatment groups
Group A: Phase 1aExperimental treatment 6 interventions
Group B: Phase 1bExperimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Rate of dose limiting toxicities (DLTs) per dose level

Assessed by the NCI-CTCAE v5.0

Time frame
During the first 28 days of ziftomenib in combination with SOC treatment (1 cycle)
2

Descriptive statistics of adverse events

Assessed by the NCI-CTCAE v5.0

Time frame
First dose of ziftomenib up to and including 28 days after last dose of ziftomenib, or if the patient is lost to follow-up, whichever comes first

Secondary outcomes

1

Complete remission (CR) rate for cohorts A-1, A-2, B-1, and B-2

Assessed by ELN 2022 criteria

Time frame
Up to 12 months following discontinuation of treatment
2

Complete remission (CR) / Complete remission with partial hematologic recovery (CRh) rate for cohort A-3

Assessed by ELN 2022 criteria

Time frame
Up to 12 months following discontinuation of treatment
3

Composite complete remission (CRc) rate

Assessed by ELN 2022 criteria

Time frame
Up to 12 months following discontinuation of treatment
4

Morphologic leukemia-free state (MLFS) rate

Assessed by ELN 2022 criteria

Time frame
Up to 12 months following discontinuation of treatment

Other outcomes

Sponsors and contacts

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

Kura Oncology, Inc.

Lead sponsor

Source ClinicalTrials.gov
Apply now