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New treatment option for Chronic Lymphocytic Leukemia
Official title Zanubrutinib, Obinutuzumab, Sonrotoclax (BOSon) or BGB-16673, Obinutuzumab, Sonrotoclax (DOSon) in TN CLL/SLL
ClinicalTrials.gov ID: NCT06849713
What this study is testing
What is Zanubrutinib?
Zanubrutinib is an investigational medicine, being studied as a potential treatment for chronic lymphocytic leukemia.
Also referred to as BGB-3111.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to determine the proportion of participants who achieve undetectable measurable residual disease (uMRD) in previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participant must have CLL or SLL (WHO criteria).
- Participant must require treatment according to iwCLL guidelines.
- Participants must have no prior systemic therapy for CLL or SLL, except:
- Prior local radiation for symptomatic disease is permitted.
- Short course systemic corticosteroids is permissible for disease control, improvement of performance status, or non-cancer indication. However...
You likely can't join if
- Known histologic transformation from CLL or SLL to an aggressive lymphoma (i.e., Richter's transformation).
- Known central nervous system involvement with CLL or SLL.
- Other diagnosis of active malignancy or systemic therapy within 2 years of study treatment. Note: An active malignancy or systemic therapy within 2...
- Any uncontrolled illness that in the opinion of the investigator would preclude administration of study therapy (e.g., significant active infections...
- Congestive heart failure, New York Heart Association III/IV. Unstable angina within 3 months before screening, myocardial infarction within 6 months...
- Receipt of a live-virus vaccine within 28 days prior to initiation of study treatment or need for live-virus vaccine at any time during study...
See the full eligibility criteria
Who can join
- Participant must have CLL or SLL (WHO criteria).
- Participant must require treatment according to iwCLL guidelines.
- Participants must have no prior systemic therapy for CLL or SLL, except:
- Prior local radiation for symptomatic disease is permitted.
- Short course systemic corticosteroids is permissible for disease control, improvement of performance status, or non-cancer indication. However, duration of steroid course must be ≤14 days with maximum daily dose of ≤100...
- Age ≥18 years.
- ECOG performance status of 0, 1 or 2.
- Participants must meet the following organ and marrow function as defined below:
- absolute neutrophil count ≥1,000/µL without growth factor support (filgrastim within 5 days or PEGfilgrastim within 10 days of test), unless clearly due to disease under study (per investigator)
- platelets ≥75,000/µL, or ≥20,000/µL if clearly due to disease under study (per investigator)
- total bilirubin ≤2 x institutional upper limit of normal (ULN), or ≤3 x institutional ULN if due to Gilbert's syndrome, or with PI approval if clearly due to disease under study
- AST(SGOT)/ALT(SGPT) ≤2.5 x × institutional ULN
- CrCl or GFR ≥30 mL/min as estimated by the Cockcroft-Gault equation, the CKD-EPI equation, or as measured by 24-hour urine collection
- For females of childbearing potential, a serum pregnancy test must be negative within screening period.
- For female patients of childbearing potential: agreement to use highly effective form(s) of contraception (i.e., one that results in a low failure rate [\<1% per year] when used consistently and correctly) or remain...
- A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (\>12 continuous months of amenorrhea with no identified cause other than menopause), and is not...
- Examples of contraceptive methods with a failure rate of \< 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and...
- The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation...
- For men with a female partner of childbearing potential or a pregnant female partner: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom in addition to 1 of the highly effective...
- Willingness to not donate or bank sperm or oocytes during the entire study treatment period and after treatment discontinuation for for ≥ 30 days after the last dose of zanubrutinib or BGB-16673 or ≥ 7 days after the...
- Ability to understand and the willingness to sign a written informed consent document. (Providing consents in as many languages as possible is encouraged)
What rules you out
- Known histologic transformation from CLL or SLL to an aggressive lymphoma (i.e., Richter's transformation).
- Known central nervous system involvement with CLL or SLL.
- Other diagnosis of active malignancy or systemic therapy within 2 years of study treatment. Note: An active malignancy or systemic therapy within 2 years for another malignancy, whose natural history or treatment does...
- Any uncontrolled illness that in the opinion of the investigator would preclude administration of study therapy (e.g., significant active infections, hypertension, angina, arrhythmias, pulmonary disease, or autoimmune...
- Congestive heart failure, New York Heart Association III/IV. Unstable angina within 3 months before screening, myocardial infarction within 6 months before screening. History of clinically significant arrhythmias (eg...
- Receipt of a live-virus vaccine within 28 days prior to initiation of study treatment or need for live-virus vaccine at any time during study treatment.
- Active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds).
- Known bleeding diathesis. History of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention.
- Prior major surgical procedure within 4 weeks of study, or anticipation of need for a major surgical procedure during the course of the study.
- Known CNS hemorrhage or stroke within 6 months of the study.
- History of progressive multifocal leukoencephalopathy.
- History of HIV infection or active hepatitis B (chronic or acute) or hepatitis C infection.
- Patients with a history of HIV infection that is well controlled on antiretroviral therapy are eligible if all of the following criteria are met: (1) undetectable HIV viral load by standard clinical assay AND (2) CD4+ T...
- Participants with occult or prior HBV infection (defined as positive total hepatitis B core antibody [HBcAb] and negative HBsAg) may be included if HBV DNA is undetectable, and if the participant is willing to take...
- Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA. Known condition or other clinical situation resulting in inability to swallow oral...
- Participant in a separate investigational therapeutic trial unless authorized by the PI.
- Concurrent therapy with, or administration within 5 half-lives 14 days prior to the first dose of study drug (whichever is shorter), with moderate or strong inhibitors or inducers of CYP3A.
- Concomitant use of warfarin or warfarin derivatives.
- Concomitant use of dual antiplatelet therapy.
- Prior systemic therapy for CLL or SLL, except for localized radiation or corticosteroids as per 3.1.3.
- Prior anti-CD20 monoclonal antibody therapy for any indication (malignant or non-malignant).
- Participants with a contraindication to obinutuzumab based on known hypersensitivity (IgE-mediated) reaction to obinutuzumab or to any of its excipients. Hypersensitivity to zanubrutinib or sonrotoclax.
- Consumption of one or more of the following within 3 days prior to the first dose of study drug: grapefruit or grapefruit products, Seville oranges including marmalade containing Seville oranges, or Star fruit...
- Known psychiatric illness or social situation that would interfere with study adherence.
- Pregnant women are excluded from this study given potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the...
- Uncontrolled autoimmune anemia and/or autoimmune thrombocytopenia (eg, idiopathic thrombocytopenia purpura), e.g., with need for ongoing corticosteroid treatment (see 3.2.24).
- Requires ongoing need for corticosteroid treatment. NOTE: Systemic corticosteroids must be fully tapered off/stopped before first study drug.
- Uncontrolled hypertension at Screening, defined as systolic blood pressure \> 170 mmHg and diastolic blood pressure \> 105 mmHg by ≥ 2 consecutive measurements. In patients NOT meeting these parameters for uncontrolled...
- Prior invasive fungal infections, except if patient agrees to receive secondary antifungal prophylaxis during the entire treatment period (Cohort 2 Only).
- Patients with known contraindication to azole antifungal agents, including hypersensitivity reactions (Cohort 2 Only).
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.