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Phase 1/2Terminated

APR-246 in Combination With Acalabrutinib or Venetoclax Based Therapy in Subjects With R/R Non Hodgkin Lymphomas (NHL)

Phase 1 and Dose Expansion Study of APR-246 in Combination With Acalabrutinib or Venetoclax-based Therapy in Subjects With R/R NHL Including Chronic Lymphocytic Leukemia (CLL) and Mantle Cell Lymphoma (MCL)

Sponsor
Aprea Therapeutics (Industry)
Enrollment
1 enrolled
Conditions
Non Hodgkin Lymphoma; Chronic Lymphocytic Leukemia; Mantle Cell Lymphoma
Interventions
APR-246 (eprenetapopt) + Acalabrutinib in CLL; APR-246 (eprenetapopt) 4.5 g/d + Venetoclax + Rituximab in CLL; APR-246 (eprenetapopt) 4.5 g/d + (Acalabrutinib, OR, (Venetoclax +Rituximab)), in CLL and/or MCL and/or RT; APR-246 (eprenetapopt) 4.5 g/d + Venetoclax + Rituximab in RT
Ages
adults, older adults
Registry
NCT04419389

Full record on ClinicalTrials.gov

From the registry

Study to determine the preliminary safety, tolerability, and pharmacokinetic (PK) profile of APR-246 in combination with either acalabrutinib or venetoclax + rituximab therapy in subjects with NHL, including relapsed and/or refractory (R/R) CLL and R/R MCL.

Primary outcomes

  • To Determine the DLT of APR-246 in Combination With Acalabrutinib or in Combination With Venetoclax + Rituximab Therapy in Subjects With NHL, Including Subjects With R/R CLL, RT and R/R MCL.
  • To Assess the Frequency of Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Related to APR-246 in Combination With Acalabrutinib and With Venetoclax + Rituximab Therapy.
  • To Determine the Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) in Subjects With TP53 Mutant NHL, Including Subjects With R/R CLL, RT and R/R MCL.

History

  1. Last registry update

  2. Results first posted

  3. Study completion

  4. Primary completion

  5. Started

  6. Registered