Phase 1b/2 Safety and Efficacy of APR-246 w/Azacitidine for tx of TP53 Mutant Myeloid Neoplasms
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 60
Summary
- Conditions
- Acute Myeloid Leukemia
- Chronic Myelomonocytic Leukemia
- Myelodysplastic Syndrome
- Myeloproliferative Neoplasm
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: Phase 1b Dose Escalation followed by Phase 2 treatment. Participants will be evaluable for inclusion in the Phase 1b and Phase 2 portions of the study if they receive at least one dose of protocol therapy.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Participants will be treated for a total of 6 cycles. For participants responding or who have stable disease following cycle 6, treatment may continue until one of the following criteria applies: Inter-current illness that prevents further administration of treatment, Unacceptable adverse event(s), ...
Participants will be treated for a total of 6 cycles. For participants responding or who have stable disease following cycle 6, treatment may continue until one of the following criteria applies: Inter-current illness that prevents further administration of treatment, Unacceptable adverse event(s), Participant decides to withdraw from the study, or General or specific changes in the participant's condition render the participant unacceptable for further treatment in the judgment of the investigator. Evidence of disease progression by the International Working Group (IWG) 2006 criteria. Participants who wish not to continue treatment at time of disease assessment at end of cycle 6 will complete their end of treatment visit upon completion of cycle 6.
Tracking Information
- NCT #
- NCT03072043
- Collaborators
- Aprea Therapeutics
- Investigators
- Principal Investigator: David Sallman, M.D. H. Lee Moffitt Cancer Center and Research Institute
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