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

Conditions

• Chronic Lymphocytic Leukemia
• Mantle Cell Lymphoma
• Non Hodgkin Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• APR-246 (eprenetapopt) + Acalabrutinib in CLL — DRUG
  APR-246 D1, 8 and 15 of each cycle Acalabrutinib will be given at a standard dose and schedule (APR 246 Monotherapy Lead-in; 4.5 g/d x 2)
• APR-246 (eprenetapopt) 4.5 g/d + Venetoclax + Rituximab in CLL — DRUG
  APR-246 D1, 8 and 15 of each cycle Venetoclax + Rituximab will be given at a standard dose and schedule (APR 246 Monotherapy Lead-in; 4.5 g/d x 2)
• APR-246 (eprenetapopt) 4.5 g/d + (Acalabrutinib, OR, (Venetoclax +Rituximab)), in CLL and/or MCL and/or RT — DRUG
  APR-246 D1, 8 and 15 of each cycle Acalabrutinib will be given at a standard dose and schedule Venetoclax and Rituxiab will be given at a standard dose and schedule
• APR-246 (eprenetapopt) 4.5 g/d + Venetoclax + Rituximab in RT — DRUG
  APR-246 4.5 g/d D1, 8 and 15 of each cycle Venetoclax + Rituximab will be given at a standard dose and schedule

Study Details

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.

Key Dates

Start date

Mar 2, 2021

Status verified

Mar 2025

Primary completion

Aug 23, 2021

Completion

Aug 24, 2021

Study Design

Enrollment

1 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Safety Lead-In Cohort 1
  APR-246 4.5 g/d + Acalabrutinib in Subjects with R/R CLL (APR 246 Monotherapy Lead-in; 4.5 g/d x 2)
• Experimental: Safety Lead-In Cohort 2
  APR-246 4.5 g/d + Venetoclax + Rituximab in Subjects with R/R CLL (APR 246 Monotherapy Lead-in; 4.5 g/d x 2).
• Experimental: Expansion Cohorts
  APR-246 4.5 g/d + (Acalabrutinib, OR, (Ven+R)) in Subjects with R/R TP53-mutant CLL, and/or MCL, and/or RT
• Experimental: Safety Lead-In Cohort 3
  APR-246 4.5 g/d + Venetoclax + Rituximab in Subjects with RT

Primary Outcome Measure

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. [ Time Frame: Through study completion, approximately 1 year ]

Locations (4)

Find similar trials in Boston, MA

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