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Phase 1a 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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Descriptive statistics of adverse events

Rate of dose limiting toxicities (DLTs) per dose level

Secondary outcome measures

6-month EFS

6-month OS

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

+17 more

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

Fludarabine

2012

Completed Phase 3

~1100

Idarubicin

2014

Completed Phase 4

~4330

Granulocyte colony-stimulating factor

2012

Completed Phase 2

~50

Cytarabine

2016

Completed Phase 3

~3310

Gilteritinib

2014

Completed Phase 2

~560

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Kura Oncology, Inc.Lead Sponsor

15 Previous Clinical Trials

1,351 Total Patients Enrolled

Clinical DevelopmentStudy DirectorKura Oncology

35 Previous Clinical Trials

88,744 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment of participants still ongoing for this clinical trial?

"Indeed, according to the information available on clinicaltrials.gov, this trial is currently seeking eligible participants. The initial posting date of the trial was December 1st, 2023 and it was last updated on December 13th, 2023."

Answered by AI

What level of risk is associated with Phase 1b trials for individuals?

"Given that Phase 1 trials have limited data supporting safety and efficacy, our team at Power assesses the safety of this Phase 1b trial to be a score of 1."

Answered by AI

What is the current number of individuals actively participating in this clinical investigation?

"Indeed, as stated on clinicaltrials.gov, this trial is presently in the recruitment phase. The initial posting of the trial occurred on December 1st, 2023 and it was last updated on December 13th, 2023. A total of 171 participants are sought after for this study at a single site."

Answered by AI

What are the principal goals that this medical study aims to achieve?

"The main objective of this clinical study, to be evaluated within the initial 28-day cycle of ziftomenib combined with standard-of-care (SOC) treatment, is to analyze descriptive statistics related to adverse events. Secondary objectives encompass assessing Gilteritinib Tmax (the time it takes for maximum plasma concentration of gilteritinib to occur), evaluating median event-free survival (EFS), and determining the composite complete remission (CRc) rate using ELN 2022 criteria."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06001788.

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