RecruitingPhase 2

Acalabrutinib With or Without Obinutuzumab in Treating Patients With Early-Stage Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Randomized Phase 2 Study Comparing Acalabrutinib to Acalabrutinib and Obinutuzumab in the Treatment of Patients With Early-Stage Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) Who Are at High Risk of Disease Progression

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 2 years, 10 years
  • Procedures mentioned: Questionnaires, Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "To evaluate the quality of life using Functional Assessment of Cancer Therapy-General (FACT-G) quality of life (QOL) survey."
  • "Paired bone marrow and blood samples will be evaluated for the levels of innate effector cells."
  • "ARM C: Patients will be observed every 6 months for up to 2 years."
  • "After completion of study treatment, patients are followed up every 6 months for up to 10 years."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests acalabrutinib alone or with obinutuzumab for adults with early-stage chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). These are cancers of white blood cells. The study is for people who have not been treated and were diagnosed less than 2 years ago.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older, with CLL confirmed by blood tests or SLL confirmed by a tissue sample. Tests must rule out mantle cell lymphoma.
  • Have no past treatment for CLL or SLL. Certain supplements and steroids used for other conditions do not count as past treatment.
  • Have all required cancer risk test results from within 730 days before joining. Your risk score determines your study group.
  • Be able to care for yourself and be up and about for at least half of your waking hours.
  • Sign a consent form and agree to return to the study center for follow-up during active monitoring.
  • Agree to give blood, saliva, and bone marrow samples for research.
  • For high-risk treatment groups only: meet required blood cell, liver, kidney, and blood-clotting test levels within 30 days before group assignment.
  • If you can become pregnant, have a negative blood pregnancy test within 7 days before joining.

Who can't join

  • CLL or SLL diagnosed 24 months or more before joining; past use of certain targeted cancer drugs, including ibrutinib or venetoclax; or use of another study drug for this cancer.
  • Leukemia or lymphoma in the brain or spinal cord, or signs that chemotherapy is needed. These include worsening low blood counts, swollen organs or lymph nodes causing symptoms or getting worse, major weight loss, extreme tiredness, lasting fever, or soaking night sweats.
  • A serious or uncontrolled illness, infection, heart problem, or mental health or social issue that could make participation unsafe or hard to complete. HIV while taking HIV medicines also excludes you; some people with HIV and no signs of weakened immunity may join.
  • Another active cancer within 2 years, except certain skin cancers, very early cervical cancer, or early prostate cancer. A heart attack within 6 months or certain serious heart failure or heart rhythm problems also excludes you.
  • For high-risk treatment groups only: pregnancy, breastfeeding, or unwillingness to use highly effective birth control if you can become pregnant.
  • For high-risk treatment groups only: active hepatitis B or C, a history of PML (a serious brain infection), or a live vaccine within 28 days before group assignment.
  • For high-risk treatment groups only: stroke or bleeding in the skull within 6 months, a bleeding disorder, or a stomach or bowel ulcer found by a scope test within 3 months before screening.
  • For high-risk treatment groups only: needing warfarin or similar blood thinners within 7 days before the first dose or during the study, or needing medicines that strongly increase the activity of a liver enzyme called CYP3A.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 Criteria: * 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

Study sites (3)

AZ

FL

MN