Acalabrutinib and Obinutuzumab for Untreated Chronic Lymphocytic Leukemia
This study is testing how well two drugs, acalabrutinib and obinutuzumab, work together to treat chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in people who haven't received treatment before. Acalabrutinib may help stop cancer cells from growing, and obinutuzumab is an immunotherapy that may help your body's immune system fight the cancer. The study aims to see how many patients remain in remission (without needing further treatment) six months after stopping the study drugs. Researchers will also look at how long people stay in remission and how well the treatment works overall. About 60 people are expected to join this study.
- Study design
- This is an interventional study, meaning participants will receive specific treatments. It is not specified if it's randomized or blinded, and the phase is not specified.
- What's involved
- You would receive acalabrutinib by mouth twice a day and obinutuzumab through an IV (into a vein) during specific cycles. Treatment could last for at least 8 cycles, with each cycle being 28 days.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure treatment-free remission up to 4 years after discontinuing acalabrutinib. Overall response rate will also be measured up to 4 years.
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NCT04505254
Acalabrutinib and Obinutuzumab for the Treatment of Chronic Lymphocytic Leukemia
Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatmentM.D. Anderson Cancer CenterInvestigator-initiated
~60 participants
Updated 2026-06-12 on ClinicalTrials.gov
What's tested:AcalabrutinibObinutuzumab
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Treatment-free remission
Measured over At 6 months after discontinuation of acalabrutinib, up to 4 years
+2 more outcomes measured
Conditions
Where it's being run
1 sites across 1 statesTexas1
Study leadership
- Jan A Burger · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Diagnosis CLL/small lymphocytic lymphoma (SLL) and be untreated
Patients must have an indication for treatment by 2018 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Criteria
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Patients of childbearing potential must be willing to practice highly effective birth control during treatment and for 2 days after the last dose of acalabrutinib or 18 months after the last dose of obinutuzumab, whichever is later
A negative urine pregnancy test (within 7 days of day 1) is required for women with childbearing potential
Adequate renal and hepatic function as indicated by all of the following: Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) except for patients with bilirubin elevation due to Gilbert's disease who will be allowed to participate
An alanine transferase (ALT) =\< 2.5 x ULN
An estimated creatinine clearance (CrCl) of \> 30 mL/min, as calculated by the Cockcroft-Gault equation unless disease related
Free of prior malignancies for 2 years with exception of patients diagnosed with basal cell or squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast who are eligible even if they are currently treated or have been treated and/or diagnosed in the past 2 years prior to study enrollment. If patients had another malignancy of indolent behavior in the past 2 years prior to study enrollment that is expected to be cured with treatment they received such patients can be enrolled, after consultation with the principal investigator
Exclusion
Pregnant or breast-feeding females
Prior CLL/SLL treatment
Known history of infection with human immunodeficiency virus (HIV) or any uncontrolled active significant infection (eg, bacterial, viral or fungal)
Signs of active hepatitis B or C. Subjects who are hepatitis B core antibody (anti-HBc) positive and who are surface antigen negative will need to have a negative polymerase chain reaction (PCR). Those who are hepatitis B surface antigen (HBsAg) positive or hepatitis B PCR positive will be excluded. Subjects who are hepatitis C antibody positive will need to have a negative PCR result. Those who are hepatitis C PCR positive will be excluded
Patients with uncontrolled autoimmune hemolytic anemia (AIHA) or autoimmune thrombocytopenia (ITP)
Patients with severe hematopoietic insufficiency as defined by an absolute neutrophil count of less than 500/μL, unless disease-related, and/or a platelet count of less than 30,000/μL at time of screening for this protocol.
Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of heart failure, or any class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification. Subjects with controlled, asymptomatic atrial fibrillation can enroll. Patients with a history of paroxysmal atrial fibrillation (PAF) or deep vein thrombosis or pulmonary embolism (DVT/PE) can be included if they had no signs of PAF or DVT/PE in the last 6 months before enrolment. Patients with ongoing atrial fibrillation (AFib) or ongoing PAF or DVT/PE should be excluded
History of stroke or cerebral hemorrhage within 6 months
Known history or evidence of bleeding diathesis or coagulopathy within 3 months
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to day 1. Bone marrow aspiration and/or biopsy are allowed
Serious, non-healing wound, ulcer, or bone fracture
Treatment with warfarin (Coumadin) or any other vitamin K antagonist. Patients who recently received warfarin must be off warfarin for at least 7 days prior to start of the study. Patients receiving novel oral anticoagulant (NOAC), also termed direct oral anticoagulant (DOAC) are permitted to enroll. Patients who are currently on a vitamin K antagonist must be switched to a non-vitamin K antagonist, such as a NOAC/DOAC
Has difficulty with or is unable to swallow oral medication, or has significant gastrointestinal disease that would limit absorption of oral medication
Known history of drug-specific hypersensitivity or anaphylaxis to study drug (including active product or excipient components)
Requires treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor/inducer
Prothrombin time (PT)/international normalized ratio (INR) or activated partial thromboplastin time (aPTT) (in the absence of lupus anticoagulant) \> 2 x ULN
Concurrent participation in another therapeutic clinical trial
What this trial measures
- Treatment-free remissionAt 6 months after discontinuation of acalabrutinib, up to 4 years
Defined as the time from discontinuation of acalabrutinib to the date of CLL relapse with active disease.
- Overall response rateAfter 6 cycles (each cycle 28 days) of treatment,up to 4 years
Defined as complete response
- Overall response rateAfter 6 cycles (each cycle 28 days) of treatment,up to 4 years
Defined as partial response