Actively Recruiting
Venetoclax-Obinutuzumab +/- Acalabrutinib in R/R CLL
Led by Massachusetts General Hospital · Updated on 2026-04-13
40
Participants Needed
3
Research Sites
436 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research study is studying a combination of drugs as a possible treatment for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The names of the study drugs involved in this study are: * obinutuzumab * venetoclax * acalabrutinib
CONDITIONS
Official Title
Venetoclax-Obinutuzumab +/- Acalabrutinib in R/R CLL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) according to WHO criteria
- Need for therapy based on iwCLL 2018 guidelines
- High or intermediate risk disease with a score of 2 or more points on the CLL BALL Risk Model
- Prior systemic therapy for CLL
- Age over 18 years
- ECOG performance status of 2 or less (Karnofsky score 60% or higher)
- Adequate organ function as defined by specific bilirubin, liver enzymes, and kidney function levels
- Adequate marrow function with specified minimum neutrophil and platelet counts
- Negative pregnancy test for females of childbearing potential within 7 days before treatment
- Agreement to use effective contraception during treatment and for a specified time after treatment
- Willingness to not donate sperm or eggs during treatment and after stopping treatment
- Ability to understand and sign informed consent
You will not qualify if you...
- Prior therapy with BTK inhibitors (e.g., acalabrutinib) or BCL2 inhibitors (e.g., venetoclax) except certain cases with undetectable MRD or complete remission
- Known allergy to obinutuzumab or its components
- Receiving other investigational agents without approval
- Known aggressive lymphoma transformation (Richter's transformation)
- Active cancer or treatment for another cancer within 3 years, with some exceptions
- Uncontrolled illness such as active infection, heart failure, unstable angina, arrhythmia, or psychiatric/social issues affecting compliance
- Active infections or recent major infection requiring IV antibiotics or hospitalization
- Known bleeding disorders
- Pregnancy or breastfeeding
- Recent major surgery within 4 weeks or planned during study
- Recent CNS hemorrhage or stroke within 6 months
- History of progressive multifocal leukoencephalopathy (PML)
- History of HIV or active hepatitis B or C infection
- Severe congestive heart failure (NYHA class III/IV)
- Significant liver disease or current alcohol abuse
- Recent live-virus vaccinations within 28 days or planned during treatment
- Conditions affecting oral drug absorption
- Use of strong inhibitors or inducers of certain liver enzymes within 7 days before first dose
- Consumption of grapefruit, Seville oranges, or star fruit within 3 days before first dose
- Need for dual antiplatelet therapy or warfarin anticoagulation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Actively Recruiting
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
Research Team
J
Jacob D Soumerai, MD
CONTACT
J
Jacob D Soumerai, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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