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Ziftomenib Combinations for Acute Myeloid Leukemia

Phase 1

Recruiting

Research Sponsored by Kura Oncology, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Has a documented NPM1 mutation or KMT2A rearrangement.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months following discontinuation of treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the safety and effectiveness of a drug called ziftomenib when used together with standard treatments for patients with a type of blood cancer called acute myeloid leukemia that has come back

Who is the study for?

This trial is for adults with relapsed/refractory acute myeloid leukemia (AML) who have specific genetic changes like NPM1 mutation or KMT2A rearrangement. Participants need to be in a stable physical condition, have good liver and kidney function, and agree to use contraception. It's not suitable for those with poor heart function.

What is being tested?

The trial tests the safety and effectiveness of Ziftomenib combined with other AML treatments: FLAG-IDA regimen, low-dose Cytarabine, or Gilteritinib. The goal is to see how well patients respond to these combinations when their AML has come back or hasn't improved after treatment.

What are the potential side effects?

Possible side effects include reactions at the infusion site, fatigue, nausea, blood cell count changes leading to increased infection risk or bleeding problems, liver and kidney issues. Each patient may experience side effects differently.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and am up and about more than half of my waking hours.

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My cancer has a specific genetic change (NPM1 mutation or KMT2A rearrangement).

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I'm sorry, but I need more information in order to provide a helpful summary. Can you please provide more details or context for the criterion you mentioned?

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My cancer has a FLT3 mutation.

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My AML cancer has returned or is not responding to treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months following discontinuation of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months following discontinuation of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months following discontinuation of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Descriptive statistics of adverse events

Rate of dose limiting toxicities (DLTs) per dose level

Secondary study objectives

6-month EFS

6-month OS

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

+17 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase 1bExperimental Treatment6 Interventions

Oral ziftomenib; Following the determination of the maximum tolerated dose in Phase 1a, participants will be enrolled in 1 of 5 dose validation/expansion cohorts: A-1: Participants with a NPM1 mutation: ziftomenib plus FLAG-IDA A-2: Participants with a NPM1 mutation: ziftomenib plus low-dose cytarabine (LDAC) A-3: Participants with a NPM1 mutation: ziftomenib plus gilteritinib B-1: Participants with a KMT2A rearrangement: ziftomenib plus FLAG-IDA B-2: Participants with a KMT2A rearrangement: ziftomenib plus low-dose cytarabine (LDAC)

Group II: Phase 1aExperimental Treatment6 Interventions

Oral ziftomenib; sequential cohorts of escalating dose levels of ziftomenib to identify the safety and tolerability of the combination regimens. Participants will be enrolled in 1 of 5 dose escalation cohorts: A-1: Participants with a NPM1 mutation: ziftomenib plus FLAG-IDA A-2: Participants with a NPM1 mutation: ziftomenib plus low-dose cytarabine (LDAC) A-3: Participants with a NPM1 mutation: ziftomenib plus gilteritinib B-1: Participants with a KMT2A rearrangement: ziftomenib plus FLAG-IDA B-2: Participants with a KMT2A rearrangement: ziftomenib plus low-dose cytarabine (LDAC)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cytarabine

2016

Completed Phase 3

~3330

Fludarabine

2012

Completed Phase 4

~1860