Trials / Recruiting
RecruitingNCT06376162
Ziftomenib in Combination With Chemotherapy for Children With Relapsed/Refractory Acute Leukemia
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
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- PedAL BCU, LLC · Academic / Other
- Sex
- All
- Age
- 0 Years – 21 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | Ziftomenib | Oral capsule |
| DRUG | Cytarabine | Intravenous (IV) infusion |
| DRUG | Fludarabine | IV infusion |
Timeline
- Start date
- 2025-03-18
- Primary completion
- 2027-01-01
- Completion
- 2027-01-01
- First posted
- 2024-04-19
- Last updated
- 2025-10-20
Locations
20 sites across 7 countries: United States, Austria, Canada, France, Italy, Netherlands, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06376162. Inclusion in this directory is not an endorsement.