Actively Recruiting
Venetoclax and Obinutuzumab Followed by Epcoritamab for the Treatment of Untreated Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, LonGEVity Trial
Led by City of Hope Medical Center · Updated on 2026-03-13
33
Participants Needed
7
Research Sites
178 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial tests the effect of venetoclax and obinutuzumab followed by epcoritamab in treating patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that have not previously received treatment. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Obinutuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Epcoritamab, a bispecific monoclonal antibody, binds to a protein called CD3, which is found on T cells (a type of white blood cell). It also binds to a protein called CD20, which is found on B cells (another type of white blood cell) and some lymphoma cells. This may help the immune system kill cancer cells. The combination of venetoclax and obinutuzumab is a standard treatment for CLL/SLL and has been found to be safe and effective. Adding epcoritamab to standard treatment with venetoclax and obinutuzumab may lead to deeper and longer-lasting responses in patients with untreated CLL/SLL.
CONDITIONS
Official Title
Venetoclax and Obinutuzumab Followed by Epcoritamab for the Treatment of Untreated Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, LonGEVity Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented informed consent and assent when appropriate
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Confirmed diagnosis of B-CLL/SLL by histology or flow cytometry
- No prior treatment for CLL/SLL except steroids or rituximab for autoimmune complications
- Evidence of CD20 positive disease
- Active disease requiring treatment by iwCLL 2018 criteria, including at least one constitutional symptom or progressive marrow failure or significant lymphadenopathy or lymphocytosis
- Ability to swallow tablets or capsules
- For patients without bone marrow involvement: absolute neutrophil count (ANC) of at least 1,000/mm3
- For patients with bone marrow involvement: ANC of at least 500/mm3
- For patients without bone marrow involvement: platelet count at least 50,000/mm3 without active bleeding
- For patients with bone marrow involvement: platelet count at least 30,000/mm3 without active bleeding
- Direct bilirubin less than or equal to 2 times upper limit of normal unless Gilbert's disease or compensated hemolysis due to CLL
- Aspartate aminotransferase (AST) less than or equal to 2.5 times upper limit of normal
- Alanine aminotransferase (ALT) less than or equal to 2.5 times upper limit of normal
- Estimated creatinine clearance of at least 40 mL/min by CKD-EPI 2009 formula
- If not on anticoagulants: INR or prothrombin time less than or equal to 1.5 times upper limit of normal
- If on anticoagulants: prothrombin time within therapeutic range
- If not on anticoagulants: activated partial thromboplastin time less than or equal to 1.5 times upper limit of normal
- If on anticoagulants: aPTT within therapeutic range
- For women of childbearing potential: negative pregnancy test and agreement to use effective contraception or abstain during treatment and specified follow-up periods
- For males: agreement to use condoms or abstain from heterosexual activity during treatment and specified follow-up periods
You will not qualify if you...
- Chronic use of corticosteroids exceeding 20 mg/day prednisone or equivalent
- Major surgery under general anesthesia within 30 days before starting treatment
- Uncontrolled bleeding disorders or coagulopathy; direct oral anticoagulants allowed
- Vaccination with live vaccines within 30 days before treatment or planned during treatment
- Transformation of CLL to aggressive non-Hodgkin lymphoma (Richter's transformation)
- Central nervous system involvement by CLL
- History of progressive multifocal leukoencephalopathy (PML)
- Prior malignancy unless treated with curative intent and no active disease for at least 2 years, or certain adequately treated skin or in situ cancers, or asymptomatic prostate cancer under observation
- Uncontrolled immune hemolysis or thrombocytopenia
- Uncontrolled active systemic infections
- Positive hepatitis C RNA test with active infection
- Chronic hepatitis B infection unless managed and monitored as specified
- HIV infection only if stable on therapy and no related comorbidities
- Pregnant or breastfeeding women
- Any condition that investigator deems unsafe for participation
- Inability to comply with study procedures due to feasibility or logistics issues
AI-Screening
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Trial Site Locations
Total: 7 locations
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
2
City of Hope at Irvine Lennar
Irvine, California, United States, 92618
Actively Recruiting
3
City of Hope at Long Beach Elm
Long Beach, California, United States, 90813
Actively Recruiting
4
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
Not Yet Recruiting
5
City of Hope Atlanta Cancer Center
Newnan, Georgia, United States, 30265
Actively Recruiting
6
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States, 10016
Not Yet Recruiting
7
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Not Yet Recruiting
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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