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

NCT06376162 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-10-20

No results posted yet for this study

Summary

The primary objective of the study 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).

Conditions

  • Relapsed/Refractory KMT2A-r Acute Leukemia
  • Relapsed/Refractory NUP98-r Acute Leukemia
  • Relapsed/Refractory NPM1-m Acute Leukemia

Interventions

DRUG

Ziftomenib

Oral capsule

DRUG

Cytarabine

Intravenous (IV) infusion

DRUG

Fludarabine

IV infusion

Sponsors & Collaborators

  • Kura Oncology

    collaborator UNKNOWN

  • PedAL BCU, LLC

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-18
Primary Completion
2027-01-31
Completion
2027-01-31
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Canada
  • France
  • Italy
  • Netherlands
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06376162 on ClinicalTrials.gov