Study of the Safety and Efficacy of APR-246 in Combination With Azacitidine
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 20
Summary
- Conditions
- Acute Myeloid Leukemia With Gene Mutations
- Chronic Myelomonocytic Leukemia
- Myelodysplastic Syndrome With Gene Mutation
- Myeloproliferative Neoplasm
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Participants will receive one dose of protocol therapyMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Patients will be treated for a total of 6 cycles.For patients responding or who have stable disease following cycle 6, treatment may continue until one of the following criteria applies: Inter-current illness that prevent further administration of treatment Unacceptable adverse event(s) Participant ...
Patients will be treated for a total of 6 cycles.For patients responding or who have stable disease following cycle 6, treatment may continue until one of the following criteria applies: Inter-current illness that prevent further administration of treatment Unacceptable adverse event(s) Participant decides to withdraw from the study, 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 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 #
- NCT03588078
- Collaborators
- Aprea Therapeutics
- Investigators
- Principal Investigator: Pierre Fenaux service Hématologie Séniors Hôpital Saint Louis
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