Acalabrutinib with or without Obinutuzumab for Early-Stage CLL/SLL
This study is looking at how well acalabrutinib, with or without obinutuzumab, works for people with early-stage chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Acalabrutinib aims to stop cancer cell growth by blocking certain enzymes. Obinutuzumab is an immunotherapy that may help your immune system fight cancer. Researchers want to see if these treatments can lead to a "minimal residual disease (MRD)-negative complete response" (meaning very few or no cancer cells are found) or delay the need for further treatment. The study plans to enroll 120 participants aged 18 and older. The current recruitment status is unclear.
- Study design
- This interventional study is testing different treatment approaches for early-stage CLL/SLL. It involves 120 participants.
- What's involved
- You would receive acalabrutinib by mouth, and possibly obinutuzumab through an IV. You would also undergo observation and quality-of-life assessments.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study measures outcomes after 12 cycles of treatment (cycles 1-6 are 28 days, cycles 7 and beyond are 84 days) or after 12 cycles (one cycle is 6 months).
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT03516617
Acalabrutinib With or Without Obinutuzumab in Treating Patients With Early-Stage Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Recruiting
PHASE2Ages 18+InterventionalTreatmentMayo ClinicInvestigator-initiated
~120 participants
Updated 2026-06-24 on ClinicalTrials.gov
What's tested:AcalabrutinibLaboratory Biomarker AnalysisObinutuzumabPatient ObservationQuality-of-Life Assessment
At a glance
Recruiting sites
2 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of minimal residual disease (MRD)-negative complete response (Arm A and Arm B)
Measured over After 12 cycles (cycle 1-6 = 28 days, cycles 7 and beyond = 84 days)
+1 more outcome measured
Conditions
Where it's being run
3 sites across 3 statesArizona1
Florida1
Minnesota1
Study leadership
- Sameer A. Parikh, M.D. · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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
Age \>= 18 years
Diagnosis of:
Biopsy-proven small lymphocytic lymphoma (SLL) , or
Diagnosis of chronic lymphocytic leukemia (CLL) with a clonal B-cell population in the peripheral blood with immunophenotyping consistent with CLL as follows:
The population of lymphocytes share both B-cell antigens (CD19, CD20 \[typically dim expression\], or CD23) as well as CD5 in the absence of other pan-T-cell markers (CD3, CD2, etc.)
Clonality as evidenced by kappa or lambda light chain expression (typically dim immunoglobulin expression) or other genetic method (e.g. IGHV analysis)
Before diagnosing CLL or SLL, mantle cell lymphoma must be excluded by demonstrating a negative fluorescence in situ hybridization (FISH) analysis for t(11;14)(IgH/CCND1)
Patients must be previously untreated
Note: Prior chemotherapy or monoclonal antibody based therapy for treatment of CLL or SLL will be considered prior therapy; nutraceutical treatments with no established benefit in CLL (such as epigallocatechin gallate or EGCG, found in green tea or other herbal treatments or supplemental vitamins) will not be considered "prior treatment"; prior corticosteroid therapy for an indication other than CLL/SLL will not be considered "prior treatment"
All patients will undergo testing for prognostic factors according to the CLL-IPI (testing obtained =\< 730 days prior to registration)
Note: If the results for any of the prognostic factors included in the CLL-IPI are unknown including IGVH mutation status results not being available due to a failed laboratory assay, the patient is not eligible
Note: When determining CLL-IPI, use most recent test results, if more than one result is available
Note: Patients with CLL-IPI risk category of high risk or very high risk (total score of 4-10) will be randomized to Arms A or B
Note: Patients with CLL-IPI risk category of low risk or intermediate risk (total score of 0-3) will be registered to Arm C
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
Provide written informed consent
Willing to provide blood and saliva samples for correlative research purposes
Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
For high risk and very high risk CLL-IPI (Arms A and B) only: Absolute neutrophil count (ANC) \>= 1500/mm\^3 (obtained =\< 30 days prior to randomization)
For high risk and very high risk CLL-IPI (Arms A and B) only: Platelet count \>= 100,000/mm\^3 (obtained =\< 30 days prior to randomization)
For high risk and very high risk CLL-IPI (Arms A and B) only: Hemoglobin \>= 11.0 g/dL (obtained =\< 30 days prior to randomization)
For high risk and very high risk CLL-IPI (Arms A and B) only: Aspartate aminotransferase (aspartate transaminase \[AST\]) =\< 3 x upper limit of normal (ULN) (obtained =\< 30 days prior to randomization)
For high risk and very high risk CLL-IPI (Arms A and B) only: Creatinine =\< 1.5 X ULN (obtained =\< 30 days prior to randomization)
For high risk and very high risk CLL-IPI (Arms A and B) only: Total bilirubin =\< 1.5 x upper limit of normal (ULN) (or total bilirubin =\< 3.0 x ULN with direct bilirubin =\< 1.5 x ULN in patients with well-documented Gilbert's syndrome (obtained =\< 30 days prior to randomization)
For high risk and very high risk CLL-IPI (Arms A and B) only: Prothrombin time (PT), international normalized ratio (INR), and partial thromboplastin time (PTT) =\< 1.5 X ULN OR if patient is receiving anticoagulant therapy and PT or PTT is within therapeutic range of intended use of coagulants (obtained =\< 30 days prior to randomization)
Negative serum pregnancy test done =\< 7 days prior to registration, for persons of childbearing potential only
Will provide bone marrow aspirate sample for correlative research purposes
Exclusion
Date of CLL/SLL diagnosis \>= 24 months prior to registration
Prior exposure to ibrutinib or to a BCR inhibitor (e.g. Btk or PI3 kinase or Syk inhibitors) or a BCL-2 inhibitor (e.g. venetoclax)
Known central nervous system (CNS) lymphoma or leukemia
Patients with any of the following indications for chemotherapy:
Evidence of progressive marrow failure as manifested by the development of or worsening anemia (=\< 11 g/dL) and/or thrombocytopenia (=\< 100 x 10\^9/L) not due to autoimmune disease
Symptomatic or progressive lymphadenopathy, splenomegaly or hepatomegaly
One or more of the following disease-related symptoms:
Weight loss \>= 10% within the previous 6 months
Extreme fatigue attributed to CLL
Fevers \>= 100.4 degrees Fahrenheit (F) for 2 weeks without evidence of infection
Drenching night sweats without evidence of infection
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
Patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy; NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Other active malignancy =\< 2 years prior to registration; EXCEPTIONS: Non-melanotic skin cancer, carcinoma-in-situ of the cervix, or early stage prostate cancer
History of myocardial infarction =\< 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
For high risk and very high risk CLL-IPI (Arms A and B) only:
Any of the following:
Pregnant persons
Nursing persons
Persons of childbearing potential who are unwilling to employ highly effective contraception
Serologic status reflecting active hepatitis B or C infection
NOTE: Subjects with hepatitis B core antibody positive who are surface antigen negative or who are hepatitis C antibody positive will need to have a negative polymerase chain reaction (PCR) result before randomization; those who are hepatitis B surface antigen positive or hepatitis B PCR positive and those who are hepatitis C PCR positive will be excluded
History of stroke or intracranial hemorrhage within 6 months before randomization
History of bleeding diathesis (e.g. hemophilia, von Willebrand disease)
Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists (e.g. phenprocoumon) within 7 days of first dose of study drug and while on study
Requires treatment with a strong CYP3A inducer
Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months before screening
History of confirmed progressive multifocal leukoencephalopathy (PML)
Received a vaccination with a live vaccine =\< 28 days prior to randomization
What this trial measures
- Rate of minimal residual disease (MRD)-negative complete response (Arm A and Arm B)After 12 cycles (cycle 1-6 = 28 days, cycles 7 and beyond = 84 days)
Defined as an objective status of complete response (CR) or CR with incomplete marrow recovery (CRi) along with MRD negativity in the bone marrow by flow cytometry. Will be compared between the two arms. The proportion of successes will be estimated in each arm by the number of successes divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true success proportion will be calculated in each arm based on the normal approximation. Comparison of MRD-negative complete response rates between the two treatment groups will be performed using a one-sided z-test (based on normal approximation with pooled variance of standardized test statistics) at significance level 0.10.
- Time to first therapy (TFT) in patients (Arm C)After 12 cycles (one cycle = 6 months)
Defined as the time from the date of registration to the date of initiation of treatment for CLL.