APR-246 in Combination With Ibrutinib or Venetoclax-R in Subjects With TP53-Mutant R/R Non Hodgkin Lymphomas (NHL)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Chronic Lymphocytic Leukemia
- Mantle Cell Lymphoma
- Non Hodgkin Lymphoma
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: Single (Participant)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Phase 1, open-label, dose-finding and cohort expansion study to determine the preliminary safety, tolerability, and pharmacokinetic (PK) profile of APR-246 (eprenetapopt) in combination with either ibrutinib or venetoclax + rituximab therapy in subjects with TP53-mutant NHL, including relapsed and/o...
Phase 1, open-label, dose-finding and cohort expansion study to determine the preliminary safety, tolerability, and pharmacokinetic (PK) profile of APR-246 (eprenetapopt) in combination with either ibrutinib or venetoclax + rituximab therapy in subjects with TP53-mutant NHL, including relapsed and/or refractory (R/R) CLL and R/R MCL. The study includes a safety lead-in portion followed by an expansion portion in subjects with R/R CLL and R/R MCL.
Tracking Information
- NCT #
- NCT04419389
- Collaborators
- Not Provided
- Investigators
- Study Director: Joachim Gullbo, MD Theradex Oncology
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