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Trial · NCT06001788

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

NCT06001788, Phase 1, Recruiting, Kura Oncology, Inc.

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia. Trials, record NCT06001788. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06001788

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia
NCT number
NCT06001788
Status
Recruiting
Phases
Phase 1
Enrollment
171 participants, estimated
Lead sponsor
Kura Oncology, Inc.
Conditions
AML, AML With Mutated NPM1, Hematologic Malignancy, KMT2Ar, NPM1 Mutation, MLL Rearrangement, Leukemia, Acute Myeloid Leukemia, Leukemia, Myeloid, Leukemia, Myeloid, Acute, Acute Leukemia, Neoplasms by Histologic Type
Interventions
Ziftomenib, Fludarabine, Idarubicin, Cytarabine, Gilteritinib, Granulocyte colony-stimulating factor
First posted
2023-08-21
Last updated
2026-08-20

Source ClinicalTrials.gov

Registered outcomes22

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryRate of dose limiting toxicities (DLTs) per dose levelDuring the first 28 days of ziftomenib in combination with SOC treatment (1 cycle)Assessed by the NCI-CTCAE v5.0
PrimaryDescriptive statistics of adverse eventsFirst 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 firstAssessed by the NCI-CTCAE v5.0
SecondaryComplete remission (CR) rate for cohorts A-1, A-2, B-1, and B-2Up to 12 months following discontinuation of treatmentAssessed by ELN 2022 criteria
SecondaryComplete remission (CR) / Complete remission with partial hematologic recovery (CRh) rate for cohort A-3Up to 12 months following discontinuation of treatmentAssessed by ELN 2022 criteria
SecondaryComposite complete remission (CRc) rateUp to 12 months following discontinuation of treatmentAssessed by ELN 2022 criteria
SecondaryMorphologic leukemia-free state (MLFS) rateUp to 12 months following discontinuation of treatmentAssessed by ELN 2022 criteria
SecondaryOSUp to 12 months following discontinuation of treatmentTo assess overall survival
Secondary6-month OSUp to 6 months following discontinuation of treatmentTo assess proportion of patients alive at 6 months
SecondaryMedian EFSUp to 12 months following discontinuation of treatmentTo assess median event free survival
Secondary6-month EFSUp to 6 months following discontinuation of treatmentTo assess 6-month event free survival

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT06001788

GET https://conductscience.org/api/trials/v1/NCT06001788/registered?page=2