TriangleThe film gives the main points. The full list below is copied from the registry; the study team makes the final decision.
- Age18 Years to 130 Years
- SexAll
- Healthy volunteersNo
You may be able to join if
- 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.