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

NCT06644183 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2026-02-11

No results posted yet for this study

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)

Conditions

Interventions

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.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Jennifer R. Brown, MD, PhD

    lead OTHER

Principal Investigators

  • Jennifer Brown, MD, PhD · Dana-Farber Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-19
Primary Completion
2028-10-01
Completion
2032-10-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06644183 on ClinicalTrials.gov