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NCT06376162 · ClinicalTrials.gov registry record · Phase 1
Ziftomenib in Combination With Chemotherapy for Children With Relapsed/Refractory Acute Leukemia
A Phase 1 study of Relapsed/Refractory KMT2A-r Acute Leukemia and Relapsed/Refractory NUP98-r Acute Leukemia, sponsored by PedAL BCU.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 20
- Study locations
NCT06376162: Recruiting Phase 1 study of Relapsed/Refractory KMT2A-r Acute Leukemia and Relapsed/Refractory NUP98-r Acute Leukemia, sponsored by PedAL BCU.
NCT06376162 is a Phase 1 study of Relapsed/Refractory KMT2A-r Acute Leukemia and Relapsed/Refractory NUP98-r Acute Leukemia that is actively recruiting participants, run by PedAL BCU. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06376162, a Phase 1 study of Relapsed/Refractory KMT2A-r Acute Leukemia and Relapsed/Refractory NUP98-r Acute Leukemia, is actively recruiting participants, sponsored by PedAL BCU.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 20
- Study locations
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 Studied
Interventions
- DRUG Fludarabine
- DRUG Cytarabine
- DRUG Ziftomenib
Study Locations (20)
Other
- Fondazione IRCCS San Gerardo dei Tintori (Ospedale San Gerardo) - Monza
- Prinses Maxima Centrum Kinderoncologie - Utrecht
- Hospital Universitari Vall d'Hebrón - Barcelona
- Hospital Infantil Universitario Niño Jesús - Madrid
California
- Children's Hospital Los Angeles - Los Angeles
Colorado
- Children's Hospital Colorado - Aurora
Georgia
- Children's Healthcare of Atlanta - Atlanta
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
Massachusetts
- Dana-Farber Cancer Institute - Boston
New York
- Memorial Sloan Kettering Cancer Center - New York - New York
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2025-03-18 |
| Est. Completion | 2027-01 |
| Phase | Phase 1 |
What NCT06376162 shows while recruiting
NCT06376162 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 3 conditions, with Relapsed/Refractory KMT2A-r Acute Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Fludarabine is the first listed.
NCT06376162 names 20 study sites across 17 states, led by Other, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT06376162 about?
NCT06376162 is a clinical study titled "Ziftomenib in Combination With Chemotherapy for Children With Relapsed/Refractory Acute Leukemia". 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).
What is the current status of trial NCT06376162?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2025-03-18. Estimated completion is 2027-01.
What conditions does trial NCT06376162 study?
This clinical trial studies the following conditions: Relapsed/Refractory KMT2A-r Acute Leukemia, Relapsed/Refractory NUP98-r Acute Leukemia, Relapsed/Refractory NPM1-m Acute Leukemia.
What interventions are being tested in trial NCT06376162?
The interventions under investigation include: Fludarabine (DRUG), Cytarabine (DRUG), Ziftomenib (DRUG).
Who is sponsoring clinical trial NCT06376162?
This trial is sponsored by PedAL BCU, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06376162 being conducted?
This trial has 20 study locations across California, Colorado, Georgia, Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06376162's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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