Actively Recruiting
Acalabrutinib and Obinutuzumab for the Treatment of Chronic Lymphocytic Leukemia
Led by M.D. Anderson Cancer Center · Updated on 2025-12-26
60
Participants Needed
1
Research Sites
357 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 investigates the how well acalabrutinib and obinutuzumab work in treating patients with chronic lymphocytic leukemia (CLL). Acalabrutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with obinutuzumab may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving acalabrutinib and obinutuzumab may help to control disease progression in CLL patients who have not received treatment for CLL.
CONDITIONS
Official Title
Acalabrutinib and Obinutuzumab for the Treatment of Chronic Lymphocytic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and untreated
- Have a medical indication for treatment according to 2018 IWCLL criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Willing to use effective birth control during treatment and for specified periods after last doses if of childbearing potential
- Negative urine pregnancy test within 7 days before starting treatment for women of childbearing potential
- Adequate kidney and liver function: total bilirubin less than or equal to 1.5 times upper limit of normal (ULN), except for Gilbert's disease
- Alanine transferase (ALT) less than or equal to 2.5 times ULN
- Estimated creatinine clearance greater than 30 mL/min unless disease-related
- Free of prior cancers for 2 years except certain skin or cervical/breast carcinomas or indolent malignancies with expected cure after consultation with investigator
You will not qualify if you...
- Pregnant or breastfeeding females
- Previous treatment for CLL or SLL
- Known HIV infection or any uncontrolled active infection
- Active hepatitis B or C infection as defined by positive surface antigen or PCR tests
- Uncontrolled autoimmune hemolytic anemia or autoimmune thrombocytopenia
- Severe low blood counts unless disease-related
- Significant heart conditions including recent heart attack or heart failure class 3 or 4; ongoing atrial fibrillation or recent blood clots
- Stroke or brain hemorrhage within 6 months
- Bleeding disorders within 3 months
- Major surgery or serious injury within 28 days; minor surgeries or biopsies within 7 days prior to treatment
- Non-healing wounds, ulcers, or bone fractures
- Use of warfarin or vitamin K antagonists within 7 days prior to study; use of novel oral anticoagulants allowed
- Difficulty swallowing oral medication or significant gastrointestinal disease affecting absorption
- History of allergic reaction to study drugs
- Need for treatment with strong CYP3A4 inhibitors or inducers
- Elevated clotting test times greater than twice ULN without lupus anticoagulant
- Participation in another therapeutic clinical trial
AI-Screening
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Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
J
Jan A Burger, 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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