A Study to Investigate the Safety of Novel Dose Ramp-up Schedule(s) When Initiating Sonrotoclax in Patients Treated for Blood Cancers

Lab values

• All patients: No ongoing clinically significant cardiovascular disease and no active infection including hepatitis B or C. In case of HIV infection, certain conditions such as CD4 count should be met. Systemic corticosteroids must be discontinued before the date of treatment start.

• All patients: Age ≥ 18 years
• Patients with CLL: • Confirmed diagnosis of CLL, based on International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines, requiring treatment as defined by at least one of the following: progressive bone marrow failure; massive, progressive, or symptomatic splenomegaly; massive, progressive, or symptomatic lymphadenopathy; progressive lymphocytosis with rapid doubling time; and/or constitutional symptoms. • At least 1 measurable lesion based on computed tomography (CT)/magnetic resonance imaging (MRI) and no history of prolymphocytic leukemia or Richter’s transformation. • Previously untreated patients: no prior systemic treatment for the disease under study.
• Patients with MCL: • Histologically confirmed diagnosis of MCL based on the World Health Organization 2022 classification of Haematolymphoid Tumors (WHO-HAEM5) or based on International Consensus Classification (ICC). • At least 1 measurable target lesion base on contrast CT/MRI scan. • Received at least 1 prior line of systemic therapy with no prior exposure to BCL2i; prior therapy may include a BTKi, provided patient was sensitive to BTKi, defined as having CR or PR during BTKi therapy and having no disease progression within 12 months after the BTKi discontinuation.