MAVRiC Studies 2L Treatment With AV in Patients With CLL/SLL Who Have Relapsed After a Course of BTKi + BCL2i Combination, With or Without Obinutuzumab

Criteria the registry did not label

• Main Inclusion Criteria:
• Participant must be ≥ 18 years at the time of signing informed consent.
• Diagnosis of relapsed CLL/SLL according to iwCLL guidelines 2018 (Hallek et al. 2018) in need of treatment.
• Participants must have received only one prior first line treatment with fixed duration covalent BTKi plus BCL2i therapy (± obinutuzumab) with a response ≥ PR (i.e., CR, CRi, nPR, or PR) for a minimum of 2 years since the end of the prior 1L treatment.
• The following data must be available or at least the appropriate samples drawn/acquired prior to dosing:
  • IGHV (mutated vs. unmutated)
  • del(17p) (present or absent)
  • TP53 mutation (present or absent)
• ECOG performance status 0, 1 or 2
• Adequate organ and bone marrow (BM) function.
  • Main Exclusion Criteria:
• 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.
• History of prior or current malignancy.
• HIV positive
• History of progressive multifocal leukoencephalopathy (PML).
• Active hepatitis B or C infection:
• Corticosteroid use \> 20 mg within 1 week before the first dose of study intervention.
• History of hypersensitivity or anaphylaxis to study intervention(s).
• Requires treatment with a strong CYP3A4 inhibitor/inducer.
• Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists.
• Major surgical procedure within 30 days of the first dose of study intervention.