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NCT06376162 · ClinicalTrials.gov record · last posted 2025-10-20

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

StatusRecruiting
PhasePhase 1
Started2025-03-18
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from the ClinicalTrials.gov record
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).

Amendment record 9 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 9 times since 2024-04-16; most recent amendment 2025-10-17. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2025-03-12
Status change Not Yet Recruiting→Recruitingv5
Trial Details
NCT Number NCT06376162
Lead Sponsor PedAL BCU, LLC
Collaborators: Kura Oncology
Conditions Relapsed/Refractory KMT2A-r Acute Leukemia, Relapsed/Refractory NUP98-r Acute Leukemia, Relapsed/Refractory NPM1-m Acute Leukemia
Enrollment 20 participants
Start Date 2025-03-18
Primary Completion 2027-01 (estimated)
Study Completion 2027-01 (estimated)
Updated on ClinicalTrials.gov 2025-10-20