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| Diagnosis | Acute Leukemia | Study Status | Open |
| Phase | I |
| Age | 0 Years to 21 Years | Randomisation | NO |
| Line of treatment | Disease relapse or progression |
| Routes of Treatment Administration | Drug: Ziftomenib (Oral capsule)
Drug: Cytarabine (Intravenous (IV))
Drug: Fludarabine (Intravenous (IV)) |
| Last Posted Update | 2025-05-14 |
| ClinicalTrials.gov # | NCT06376162 |
International Sponsor
LLS PedAL Initiative, LLCPrincipal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Jim WhitlockCentres
Study Description
The objective of this study is to determine the safety and efficacy of a drug called ziftomenib in combination with chemotherapy in children with acute leukemia that has progressed or come back with specific genetic mutations.
Inclusion Criteria
- Participants up to 21 years old that weigh at least 5kg
- Has leukemia that came back or didn’t respond to treatment and has a has a specific gene change
- Participants must be up and about at least 50% of waking hours, wheelchair use is included
- Must meet all blood work and organ function requirements
- Must have had enough time to recover from any past treatments
- Must first enroll in APAL2020SC prior to enrollment in this trial
- Participant or Parent/Guardian must sign informed consent form
Other inclusion or exclusion criteria may apply and will be discussed with you by the study team
