RecruitingPhase 1Phase 2NCT06644183

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


Sponsor

Jennifer R. Brown, MD, PhD

Enrollment

64 participants

Start Date

Mar 19, 2025

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing roginolisib (IOA-244) combined with venetoclax and rituximab for patients with chronic lymphocytic leukemia (CLL) — a slow-growing blood cancer — that has come back or stopped responding to prior treatments including a BTK inhibitor. **You may be eligible if...** - You have been diagnosed with CLL that has relapsed or is no longer responding to treatment - You have received at least two prior CLL therapies, including a BTK inhibitor (such as ibrutinib or acalabrutinib) - You are 18 years or older - You are willing to have bone marrow biopsies before and during treatment - Your organ function (kidney, liver, blood counts) meets required levels **You may NOT be eligible if...** - You have active, symptomatic CLL that has spread to the central nervous system and is untreated - Your kidney function or blood counts fall significantly below required levels - You are pregnant or breastfeeding - You have other active cancers requiring treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRoginolisib

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

DRUGVenetoclax

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

DRUGRituximab

Chimeric anti-CD 20 monoclonal antibody, single-use 10 and 50mL vials, via intravenous (into the vein) infusion per standard of care.


Locations(1)

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

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NCT06644183


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