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| Diagnosis | Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Mixed Lineage Acute Leukemia Mixed Phenotype Acute Leukemia Acute Leukemia of Ambiguous Lineage | Study Status | Open |
| Phase | I/II |
| Age | up to 18 Years | Randomisation | NO |
| Line of treatment | First line treatment, Disease relapse or progression |
| Routes of Treatment Administration | Drug: SNDX-5613 (given orally)
Drug: Cobicistat (Patients in Phase 1 Arm C patients will receive 150 mg cobicistat daily)
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| Last Posted Update | 2023-09-28 |
| ClinicalTrials.gov # | NCT04065399 |
International Sponsor
Syndax PharmaceuticalsPrincipal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Jim Whitlock Centres
Study Description
This is a phase I/II study that studies the drug SNDX-5613 in patients with acute leukemia. In phase 1, the dose will be increased to find the maximum tolerated dose of SNDX-5613 and the recommended dose for the next phase will be determined. In phase 2, patients will be given the recommended phase 2 dose determined in phase 1, and the safety and efficacy in patients with various tumour mutation will be studied.
Inclusion Criteria
- Patients must have active acute leukemia with certain genetic characteristics
- Patients must be over 30 days old
- Patients must be up and about more than 50% of waking hours (if applicable)
- Adequate time must have passed from all previous treatments (i.e at least 60 days must have passed from last radiation treatment/stem cell infusion (if applicable))
- Adeqaute organ function
- Blood work must come back within acceptable ranges
- Patients of child bearing potential must be willing to use a highly effective method of contraception from the time of enrollment to 120 days after the last study drug dose
- Patients and/or their families/caregivers must sign a consent form outlining all assessments and requirements
