Ziftomenib in Combination With Chemotherapy for Children With Relapsed/Refractory Acute Leukemia

ClinicalTrials.gov ID: NCT06376162

Public ClinicalTrials.gov record NCT06376162. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 27, 2026, 11:28 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 1 Trial of Menin-inhibitor Ziftomenib in Combination With Chemotherapy for Children With Relapsed/Refractory KMT2A-r/NUP98-r/NPM1-m Acute Leukemia

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The primary objective of the trial is to determine the recommended phase 2 dose (RP2D) of ziftomenib in combination with chemotherapy (FLA) in children with relapsed or refractory KMT2A-r, NUP98-r, or NPM1-m acute leukemia based on safety and pharmacokinetics (PK).

Study identification

NCT ID: NCT06376162
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 1
Lead sponsor: PedAL BCU, LLC; Other
Enrollment: 20 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range: 0 Years to 21 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Mar 18, 2025 (Actual)
Primary completion: Mar 2033 (Estimated)
Completion: Mar 2033 (Estimated)
Last update posted: Oct 9, 2026

2025 – 2033

United States locations

U.S. sites: 11
U.S. states: 11
U.S. cities: 11

Facility	City	State	ZIP	Site status
Children's Hospital Los Angeles	Los Angeles	California	90027	Recruiting
Children's Hospital Colorado	Aurora	Colorado	80045	Recruiting
Children's Healthcare of Atlanta	Atlanta	Georgia	30329	Recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois	60611	Recruiting
Dana-Farber Cancer Institute	Boston	Massachusetts	02215	Recruiting
Memorial Sloan Kettering Cancer Center - New York	New York	New York	10065	Recruiting
Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	45229-3026	Recruiting
Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	19104	Recruiting
St. Jude Children's Research Hospital	Memphis	Tennessee	38105-3678	Recruiting
Texas Children's Hospital	Houston	Texas	77030	Recruiting
Seattle Children's Hospital	Seattle	Washington	98105	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 9 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06376162, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Oct 9, 2026 · Synced Oct 27, 2026

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The complete public registry record, listed eligibility criteria, and available contact information for NCT06376162 live on ClinicalTrials.gov.

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