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New treatment option for Chronic Lymphocytic Leukemia (CLL)
Official title Study of Zanubrutinib, Obinutuzumab, and Venetoclax in Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL)
ClinicalTrials.gov ID: NCT03824483
What this study is testing
What is Zanubrutinib?
Zanubrutinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for chronic lymphocytic leukemia (cll).
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 rate of minimum residual disease (MRD) negative response (i.e. the rate of no evidence of disease) of the study drugs, zanubrutinib, obinutuzumab, and venetoclax, given in combination as a treatment for CLL and/or 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
- \- Signed, informed consent
- Ability and willingness to comply with the requirements of the study protocol
- Age ≥18 years
- Diagnosis of the following histories according to the WHO criteria
- CLL or SLL
You likely can't join if
- Other malignancies:
- Known active histological transformation from CLL to an aggressive lymphoma (i.e., Richter"s transformation)
- Active malignancy or systemic therapy for another malignancy within 3 years; local/regional therapy with curative intent such as surgical resection...
- Other diagnosis of active cancer Co-morbidities: \- Any uncontrolled illness that in the opinion of the investigator would preclude administration of...
- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment...
- Known bleeding diathesis
See the full eligibility criteria
Who can join
- \- Signed, informed consent
- Ability and willingness to comply with the requirements of the study protocol
- Age ≥18 years
- Diagnosis of the following histories according to the WHO criteria
- CLL or SLL
- For patients with SLL, peripheral blood flow cytometry must be positive with CLL-like cells accounting for at least 1% of circulating WBC.
- No prior systemic therapy for disease under study 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 (must be ≤ 14 days and \< 100 mg/day prednisone or ≤ 20 mg/day dexamethasone)...
- ECOG performance status of 0 to 2
- Adequate hematologic parameters unless due to disease under study:
- Absolute neutrophil count (ANC) ≥1.0 x 109/L unless neutropenia is clearly due to disease under study (per investigator discretion)
- Platelet count ≥ 75,000/mm3 - OR - Platelet count ≥ 20,000/mm3 if thrombocytopenia is clearly due to disease under study (per investigator discretion)
- Hemoglobin ≥9.0 g/dL unless anemia is clearly due to marrow involvement due to disease under study (per investigator discretion)
- Adequate renal and hepatic function, per laboratory reference range at Screening as follows: a. AST/SGOT, ALT/SGPT ≤2.0 x ULN b. Total bilirubin ≤ 2.0 x ULN unless: i. Considered secondary to Gilbert"s syndrome, in...
- For females of childbearing potential, a negative serum pregnancy test within 7 days of study treatment
- 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 [\ /= 12 continuous months of amenorrhea with no identified cause...
- 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 partnet: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom during the treatment period and to continue its...
- Diagnosis of untreated stage II-IV mantle cell lymphoma
- Prior radiotherapy for localized disease is permitted
- Patients must meet one of the following criteria (a or b): a. Age ≥65 years If age \<65 years of age, then patients must be ineligible for HDT/ASCT on the basis of comorbidity or organ dysfunction. Specifically...
What rules you out
- Other malignancies:
- Known active histological transformation from CLL to an aggressive lymphoma (i.e., Richter"s transformation)
- Active malignancy or systemic therapy for another malignancy within 3 years; local/regional therapy with curative intent such as surgical resection or localized radiation within 3 years of treatment is permitted
- Other diagnosis of active cancer Co-morbidities: \- Any uncontrolled illness that in the opinion of the investigator would preclude administration of study therapy (e.g. significant active infections, hypertension...
- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV...
- Known bleeding diathesis
- 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 (PML)
- History of HIV 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...
- Active hepatitis B (chronic or acute) or hepatitis C infection a. Patients with occult or prior HBV infection (defined as positive total hepatitis B core antibody [HBcAb] and negative HBsAg) may be included if HBV DNA...
- Congestive heart failure, New York Heart Association classification III/IV
- Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
- Receipt of live-virus vaccines within 28 days prior to the initiation of study treatment or need for live-virus vaccines at any time during study treatment
- Known condition or other clinical situation that would affect oral absorption
- Psychiatric illness/social situations that would interfere with study compliance
- Inability to swallow a large number of tablets Concomitant medications and drug interactions: \- Administration within 7 days prior to the first dose of study drug or concurrent therapy with strong inhibitors or...
- Live-virus vaccines given within 28 days prior to the initiation of study treatment
- Immunotherapy
- Hormone therapy (other than contraceptives, hormone replacement therapy, or megestrol acetate)
- Any therapies intended for the treatment of lymphoma/leukemia whether FDA approved or experimental (outside of this study)
- Radiation therapy intended to treat MCL or CLL/SLL
- Warfarin or warfarin derivatives
- 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 Star Fruit (carambola)...
- Prior anti-CD20 monoclonal antibody therapy for non-malignant indication
- Obinutuzumab is contraindicated in patients with a known hypersensitivity (IgE-mediated) reaction to obinutuzumab or to any of its excipients
- Prior systemic therapy for CLL; prior single site of local radiation for symptomatic disease is permitted Other:
- Females who are currently pregnant or breastfeeding
- Participation in a separate investigational therapeutic study unless authorized by the investigator
The study team makes the final eligibility decision.
Where it's taking place
- Evanston, Illinois, United States
- Boston, Massachusetts, United States
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, 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 Evanston, Illinois, United States; Boston, Massachusetts, United States; Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States and 2 more location(s). 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.