Actively Recruiting
Intermittent Versus Continuous Venetoclax With Acalabrutinib for CLL/SLL
Led by Zulfa Omer · Updated on 2026-01-06
62
Participants Needed
1
Research Sites
339 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a randomized Phase II study of intermittent versus continuous venetoclax therapy with Acalabrutinib in previously untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
CONDITIONS
Official Title
Intermittent Versus Continuous Venetoclax With Acalabrutinib for CLL/SLL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL) requiring therapy and previously untreated
- Age 18 years or older
- ECOG performance status of 0, 1, or 2 without recent deterioration
- Adequate organ and marrow function including specific blood count and liver/kidney function thresholds
- Agreement from women who can bear children to use effective contraception during and shortly after treatment
- Agreement from sexually active men to use effective contraception including barrier methods during the study
- Men must agree to avoid sperm donation during the study
- Ability and willingness to participate in all study procedures including swallowing tablets
- Ability to understand study risks and provide informed consent
You will not qualify if you...
- Presence of severe or uncontrolled systemic diseases making study participation unsafe
- Active Richter's transformation
- History or presence of central nervous system lymphoma
- Recent use of investigational drugs within 30 days or 5 half-lives
- Major surgery within 30 days without full recovery
- Prior malignancies affecting compliance or results, except certain treated skin, cervical, breast, prostate cancers and others disease-free for 3 years
- Significant cardiovascular disease including recent serious heart events
- Conditions affecting drug absorption or metabolism such as severe gastrointestinal disorders or surgeries
- Recent live virus vaccination within 28 days
- Uncontrolled HIV infection
- History or current progressive multifocal leukoencephalopathy (PML)
- Active uncontrolled infections including positive CMV PCR
- Active hepatitis B or C infection as defined by PCR testing
- Recent stroke or brain bleeding within 6 months
- Uncontrolled bleeding disorders
- Use of warfarin or similar anticoagulants
- Use of strong CYP3A inhibitors or inducers near study start
- Pregnancy or breastfeeding
- Participation in another therapeutic clinical trial
- Life-threatening illness or severe organ dysfunction
- Use of P-glycoprotein inhibitors during venetoclax initiation
- Inability to receive Prevnar vaccination
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Cincinnati
Cincinnati, Ohio, United States, 45219
Actively Recruiting
Research Team
U
UCCC Clinical Trials Office
CONTACT
Z
Zulfa Omer, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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