Actively Recruiting
Roginolisib (IOA-244) With Venetoclax and Rituximab for Refractory/Relapsed Chronic Lymphocytic Leukemia (CLL)
Led by Jennifer R. Brown, MD, PhD · Updated on 2026-02-11
64
Participants Needed
1
Research Sites
393 weeks
Total Duration
On this page
Sponsors
J
Jennifer R. Brown, MD, PhD
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Roginolisib (IOA-244) With Venetoclax and Rituximab for Refractory/Relapsed Chronic Lymphocytic Leukemia (CLL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with relapsed or refractory CLL requiring treatment based on iwCLL criteria
- Measurable disease by circulating lymphocytes, bone marrow involvement, or enlarged spleen/lymph nodes
- At least two prior CLL therapies including covalent BTK inhibitor
- Willingness to undergo bone marrow biopsies before and during treatment
- Age 18 years or older at informed consent
- ECOG performance status 0 to 2
- Adequate organ and marrow function as specified
- Clinically inactive or treated CNS disease allowed with required imaging and lumbar puncture if symptomatic
- Willingness to use adequate contraception during study participation
- Ability to understand and sign informed consent
- Eligible for infection prophylaxis and supportive care per guidelines
You will not qualify if you...
- Prior treatment with venetoclax or PI3K inhibitors within 6 months
- Recent live vaccine within 30 days of study therapy start
- Ongoing high-dose immunosuppressants or systemic steroids above specified doses
- History of transformation of CLL to aggressive lymphoma
- Unresolved adverse events from prior cancer therapies above Grade 1 except alopecia or fatigue
- Receiving other investigational agents for CLL
- History of allergic reactions to study drugs or similar compounds
- History of systemic autoimmune disease
- Use of strong CYP3A inhibitors or inducers with specific venetoclax dosing restrictions
- Pregnant or breastfeeding women
- Other malignancies requiring interfering therapy or not meeting specified remission criteria
- Inability to swallow oral medication
- Cardiovascular disease impacting participation or prolonged QTc interval
- Recent tuberculosis treatment
- Active systemic infections requiring IV antimicrobial treatment
- Known HIV infection with treatment interfering with venetoclax
- Serious uncontrolled medical disorders or active infections posing risk
- Known alcohol or substance abuse
AI-Screening
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Trial Site Locations
Total: 1 location
1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
H
Hang Phan, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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