Roginolisib + Venetoclax and Rituximab

Phosphoinositide 3-kinase delta inhibitor, 40 mg capsule, taken orally per protocol.

B-cell lymphoma 2 inhibitor, 10, 50, and 100mg tablets, taken orally per standard of care.

This is a Phase I/II, open-label, randomized, and comparator controlled study to test the safety and anticancer activity of the combination of three drugs (Roginolisib, Venetoclax, and Rituximab) for participants with relapsed or refractory Chronic Lymphocytic Leukemia (CLL). In this study, investigators are assessing whether adding the study drug, Roginolisib, will lead to deeper responses than the standard combination of Venetoclax and Rituximab alone.

This research study will test the safety and anticancer activity of the combination of three drugs (Roginolisib, Venetoclax, and Rituximab) for participants with relapsed or refractory Chronic Lymphocytic Leukemia (CLL). The names of the study drugs involved in this study are: * Roginolisib (a novel type of PI3-kinase delta inhibitor) * Venetoclax (a type of B-cell lymphoma 2 inhibitor) * Rituximab (a type of monoclonal antibody)

Live record on ClinicalTrials.gov →

• Patients with relapsed/refractory CLL who meet iwCLL criteria for requiring treatment.
• Patients with measurable disease as defined by at least one of: circulating lymphocytosis > 5000 B cells/microliter, bone marrow involvement > 30%, palpable splenomegaly or lymph nodes > 1.5 cm. Computer tomography (CT) at screening must be performed and followed every 2 cycles (1 cycle = 28 days).
• Patients must have received at least two prior therapies for CLL including systemic therapy containing a covalent BTK inhibitor.
• Patients willing to undergo a pre-treatment and on treatment bone marrow biopsy.
• Age ≥18 years, at the time of signing the IRB approved informed consent. Because no dosing or adverse event data are currently available on the use of venetoclax in combination with roginolisib in participants <18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.

Inclusion criteria as written on the registry, trimmed. The full list, with exclusions, is on the live record.