NCT06644183

Roginolisib (IOA-244) With Venetoclax and Rituximab for Refractory/Relapsed Chronic Lymphocytic Leukemia (CLL)

A Phase 1/2, Open Label, Study of Roginolisib (IOA-244), an Orally Bioavailable, Selective PI3Kδ Inhibitor in Patients With Refractory/Relapsed Chronic Lymphocytic Leukemia (CLL) in Combination With Venetoclax and Rituximab

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Jennifer R. Brown, MD, PhD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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)

Detailed description

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. A phase Ib safety lead-in portion of the trial will determine the dose and tolerability of Roginolisib with the standard 2-drug combination treatment of Venetoclax + Rituximab. In the phase 2 portion of the trial, participants will be randomized into one of two treatment arms: Arm A: Roginolisib + Venetoclax and Rituximab vs. Arm B: Venetoclax and Rituximab. Randomization means a participant is placed into a treatment arm by chance. The U.S. Food and Drug Administration (FDA) has not approved Roginolisib as a treatment for relapsed or refractory CLL. The U.S. FDA has approved Venetoclax and Rituximab as a standard 2-drug combination treatment for relapsed or refractory CLL. The research study procedures include screening for eligibility in-clinic visits, blood tests, urine tests, electrocardiograms (ECGs), Computerized Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans, and bone marrow biopsy and/or aspirations. Participants will receive study treatment for approximately 12 months and will be followed for up to 5 years. It is expected about 3-12 people will take part in the Phase 1 portion of the trial, and 52 people will participate in the Phase 2 portion of the research study. iOnctura SA is supporting this research study by providing the study drug, Roginolisib. The U.S. Department of Defense (DOD) is supporting this research study by providing funding.

Conditions

• Leukemia
• Relapsed Leukemia
• Chronic Lymphocytic Leukemia
• Relapsed Cancer
• Refractory Leukemia

Interventions

Type	Name	Description
DRUG	Roginolisib	Phosphoinositide 3-kinase delta inhibitor, 40 mg capsule, taken orally per protocol.
DRUG	Venetoclax	B-cell lymphoma 2 inhibitor, 10, 50, and 100mg tablets, taken orally per standard of care.
DRUG	Rituximab	Chimeric anti-CD 20 monoclonal antibody, single-use 10 and 50mL vials, via intravenous (into the vein) infusion per standard of care.

Timeline

• Start date: 2025-03-19
• Primary completion: 2028-10-01
• Completion: 2032-10-01
• First posted: 2024-10-16
• Last updated: 2026-02-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study