Phase 2 Study of Disease Risk Mutation-Guided Finite Acalabrutinib+Venetoclax for Relapsed CLL Post-1L Finite cBTKi+BCL2i ± Obinutuzumab

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-130
SponsorAstraZeneca

About this trial

This study will evaluate the efficacy and safety of finite-duration acalabrutinib plus venetoclax therapy in patients with relapsed CLL or SLL, and have previously responded to first line (1L) cBTKi + BCL2i therapy (± obinutuzumab) and maintained a response for at least two years post-treatment.

Eligibility criteria

Qualifiers

Participant must be ≥ 18 years at the time of signing informed consent.

Diagnosis of CLL/SLL according to iwCLL guidelines 2018 (Hallek et al. 2018)

Participants must have received first line treatment with fixed duration covalent BTKi plus BCL2i therapy (± obinutuzumab) with a response ≥ PR (i.e., CR, CRi, nPR, or PR) with a minimum of 2 years since the end of the prior 1L treatment.

IGHV (mutated vs. unmutated)

Disqualifiers

Any evidence of diseases that, in the investigator's opinion, makes it undesirable for patient to participate in the study.

Significant cardiovascular or cerebrovascular disease.

Active bleeding or history of bleeding diathesis (e.g., hemophilia or von Willebrand disease).

Child-Pugh B/C liver cirrhosis.

Trial design

Treatments tested in this trial

  • Acalabrutinib
  • Venetoclax

Treatment groups

80 Participants
are divided into 1 treatment group

Sponsors and collaborators

AstraZeneca

Lead sponsor

AbbVie

Collaborator

Genentech, Inc.

Collaborator