Actively Recruiting
Acalabrutinib and Venetoclax With or Without Early Obinutuzumab for the Treatment of High Risk, Recurrent, or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Led by M.D. Anderson Cancer Center · Updated on 2026-04-14
168
Participants Needed
1
Research Sites
310 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial studies how well acalabrutinib and venetoclax with or without early obinutuzumab work for the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma that is high risk, has come back (recurrent), or does not respond to treatment (refractory). Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Venetoclax may stop the growth cancer cells by blocking BCL-2 protein needed for cell growth. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving acalabrutinib and venetoclax together with early obinutuzumab may improve clinical outcomes and control the disease.
CONDITIONS
Official Title
Acalabrutinib and Venetoclax With or Without Early Obinutuzumab for the Treatment of High Risk, Recurrent, or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) requiring treatment by 2018 iwCLL criteria
- For untreated patients: at least one high-risk feature or age 65 years or older
- For relapsed or refractory patients: relapsed after or refractory to at least one prior therapy
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Adequate kidney and liver function as defined by study criteria
- Absolute neutrophil count above 750 neutrophils/L unless due to marrow infiltration
- Platelet count above 30,000/µl without recent transfusion unless due to marrow infiltration
- Women of childbearing potential must have a negative pregnancy test and agree to use contraception during and after the study as specified
- Men who are sexually active must agree to use effective contraception during and after the study as specified
- No prior malignancies for 2 years except certain skin cancers and cervical or breast carcinoma in situ
- Written informed consent provided
You will not qualify if you...
- Prior combined treatment with BTKi and BCL2i without at least partial response or disease progression within 2 years
- Major treatments or live virus vaccination within 3 weeks before starting study drugs unless rapid disease progression
- Severe allergic reactions to monoclonal antibodies or known allergies to murine products
- Active uncontrolled infections
- Known HIV infection
- Active hepatitis B or C infection
- Active uncontrolled autoimmune conditions needing high-dose steroids
- Significant cardiovascular disease including recent heart attack or severe heart failure
- Pregnancy or breastfeeding
- Concurrent use of warfarin
- Recent use of strong CYP3A inhibitors or inducers around venetoclax administration
- Recent consumption of certain fruits affecting venetoclax
- Known bleeding disorders or recent stroke or brain bleeding
- Conditions preventing oral medication use
- Other severe medical or psychiatric conditions increasing risk or interfering with study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
W
William G Wierda
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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