Actively Recruiting
Acalabrutinib With or Without Obinutuzumab in Treating Patients With Early-Stage Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Led by Mayo Clinic · Updated on 2026-02-09
120
Participants Needed
3
Research Sites
631 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase II trials studies how well acalabrutinib with or without obinutuzumab works in treating patients with early-stage chronic lymphocytic leukemia or small lymphocytic lymphoma. Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes 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. It is not yet known whether giving acalabrutinib with or without obinutuzumab will work better in treating patients with early-stage chronic lymphocytic leukemia or small lymphocytic lymphoma.
CONDITIONS
Official Title
Acalabrutinib With or Without Obinutuzumab in Treating Patients With Early-Stage Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of biopsy-proven small lymphocytic lymphoma or chronic lymphocytic leukemia confirmed by specific immune markers
- No prior treatment for CLL or SLL (except certain non-chemotherapy agents)
- Testing for prognostic factors according to CLL-IPI done within 730 days before registration
- High or very high risk by CLL-IPI for Arms A and B; low or intermediate risk for Arm C
- Eastern Cooperative Oncology Group performance status 0, 1, or 2
- Willing to provide informed consent and samples for research
- Able to return for follow-up during active monitoring
- For Arms A and B: Specific blood counts and liver/kidney function within normal limits
- Negative pregnancy test for persons who can become pregnant
- Willing to provide bone marrow aspirate sample for research
You will not qualify if you...
- Diagnosis of CLL or SLL more than 24 months before registration
- Prior use of ibrutinib, BCR inhibitors, or BCL-2 inhibitors
- Known central nervous system lymphoma or leukemia
- Indications for chemotherapy such as worsening anemia or thrombocytopenia not caused by autoimmune disease
- Symptoms like significant weight loss, extreme fatigue, prolonged fever, or night sweats without infection
- Serious systemic illnesses or diseases interfering with safety assessment
- Known HIV positive on antiretroviral treatment (unless no immunocompromised state)
- Uncontrolled infections, heart failure, unstable angina, arrhythmia, or psychiatric/social issues limiting compliance
- Receiving other investigational agents for primary cancer
- Other active cancers within 2 years except certain skin, cervical, or prostate cancers
- Recent heart attack or severe heart conditions
- For Arms A and B: Pregnancy, nursing, or unwillingness to use effective contraception
- Active hepatitis B or C infection or positive tests requiring exclusion
- Recent stroke or brain bleeding
- Bleeding disorders
- Use of warfarin or similar anticoagulants within 7 days before study drug
- Treatment with strong CYP3A inducers
- Recent gastrointestinal ulcers
- History of progressive multifocal leukoencephalopathy
- Live vaccine received within 28 days before randomization
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Actively Recruiting
2
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
Actively Recruiting
3
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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