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A Phase 3 Study of Zanubrutinib (BGB-3111) Compared with Bendamustine plus Rituximab in Patients with Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
EU CTIS ID: 2023-509976-40-00
What this study is testing
To compare efficacy between treatment groups in Cohort 1, as measured by progression-free survival determined by independent central review
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients must be unsuitable for treatment with FCR defined as: ≥ 65 years of age at the time of informed consent, OR 18 - 64 years of age and have one or more of the following factors: a. Cumulative Illness Rating Scale (CIRS) score > 6. A CIRS is not required, it may be used to meet this inclusion requirement. b. Creatinine clearance < 70 mL/min c. History of previous serious infection or multiple infections in the past 2 years NOTE: For Arm D only: -Patients without del17p: must meet one of the above criteria for unsuitability for FCR. -Patients with del17p/TP53 variant: central laboratory confirmation of del17p-positive CLL/SLL will fulfill the requirement for unsuitability for FCR. For patients with a central FISH test result other than del17ppositive CLL/SLL, a local laboratory test result documenting pathogenicTP53 variant may meet this requirement (refer to Appendix 18 of PA5).
- Male patients are eligible if vasectomized or if they agree to the use of barrier contraception with other methods described above during the study treatment period and for ≥ 90 days after the last dose of zanubrutinib or 3 months after the last dose of bendamustine whichever is longer
- Ability to provide written informed consent and can understand and comply with the requirements of the study
- Must have FISH results from the study-specified central laboratory confirming the presence or absence of del17p.a. For Arm D only: Patients must have a central laboratory FISH test for del17p performed. A patient with a result other than "with del17p" may be eligible for enrollment into the del17p-positive subset only if the patient has a pathogenic TP53 variant previously documented per local laboratory test meeting the criteria specified in Appendix 18.
- Confirmed diagnosis of CD20-positive CLL or SLL that meets the CLL criteria (Hallek et al, 2008)
- Measurable disease by CT/MRI. Measurable disease is defined as ≥ 1 lymph node > 1.5 cm in longest diameter and measurable in 2 perpendicular diameters
You likely can't join if
- Previous systemic treatment for CLL/SLL
- Active fungal, bacterial and/or viral infection requiring systemic therapy
- Known central nervous system involvement by leukemia or lymphoma
- Underlying medical conditions that, in the investigator's opinion, will render the administration of study drug hazardous or obscure the interpretation of toxicity or AEs
- Known infection with HIV, or serologic status reflecting active hepatitis B or C infection
- Major surgery within 4 weeks of the first dose of study drug
See the full eligibility criteria
Who can join
- Patients must be unsuitable for treatment with FCR defined as: ≥ 65 years of age at the time of informed consent, OR 18 - 64 years of age and have one or more of the following factors: a. Cumulative Illness Rating Scale (CIRS) score > 6. A CIRS is not required, it may be used to meet this inclusion requirement. b. Creatinine clearance < 70 mL/min c. History of previous serious infection or multiple infections in the past 2 years NOTE: For Arm D only: -Patients without del17p: must meet one of the above criteria for unsuitability for FCR. -Patients with del17p/TP53 variant: central laboratory confirmation of del17p-positive CLL/SLL will fulfill the requirement for unsuitability for FCR. For patients with a central FISH test result other than del17ppositive CLL/SLL, a local laboratory test result documenting pathogenicTP53 variant may meet this requirement (refer to Appendix 18 of PA5).
- Male patients are eligible if vasectomized or if they agree to the use of barrier contraception with other methods described above during the study treatment period and for ≥ 90 days after the last dose of zanubrutinib or 3 months after the last dose of bendamustine whichever is longer
- Ability to provide written informed consent and can understand and comply with the requirements of the study
- Must have FISH results from the study-specified central laboratory confirming the presence or absence of del17p.a. For Arm D only: Patients must have a central laboratory FISH test for del17p performed. A patient with a result other than "with del17p" may be eligible for enrollment into the del17p-positive subset only if the patient has a pathogenic TP53 variant previously documented per local laboratory test meeting the criteria specified in Appendix 18.
- Confirmed diagnosis of CD20-positive CLL or SLL that meets the CLL criteria (Hallek et al, 2008)
- Measurable disease by CT/MRI. Measurable disease is defined as ≥ 1 lymph node > 1.5 cm in longest diameter and measurable in 2 perpendicular diameters
- CLL/SLL requiring treatment
- ECOG performance status of 0, 1, or 2
- Life expectancy ≥ 6 months
- Adequate bone marrow function
- Patient must have adequate organ function
- Female patients of childbearing potential must practice highly effective methods of contraception initiated prior to first dose of study drug, for the duration of the study, and for ≥ 90 days after the last dose of zanubrutinib, ≥ 30 days after the last dose of venetoclax,3 months after the last dose of bendamustine, or 12 months after the last dose of rituximab, whichever is longer
What rules you out
- Previous systemic treatment for CLL/SLL
- Active fungal, bacterial and/or viral infection requiring systemic therapy
- Known central nervous system involvement by leukemia or lymphoma
- Underlying medical conditions that, in the investigator's opinion, will render the administration of study drug hazardous or obscure the interpretation of toxicity or AEs
- Known infection with HIV, or serologic status reflecting active hepatitis B or C infection
- Major surgery within 4 weeks of the first dose of study drug
- Pregnant or lactating women
- Vaccination with a live vaccine within 35 days prior to the first dose of study drug
- Ongoing alcohol or drug addiction
- Hypersensitivity to zanubrutinib, bendamustine, rituximab or venetoclax (as applicable) or any of the other ingredients of the applicable study drugs
- Requires ongoing treatment with a strong CYP3A inhibitor or inducer
- Requires ongoing need for corticosteroid treatment. NOTE: Systemic corticosteroids must be fully tapered off/stopped at least 5 days before day of first study drug
- Concurrent participation in another therapeutic clinical study
- Active and/or ongoing autoimmune anemia and/or autoimmune thrombocytopenia (eg, idiopathic thrombocytopenia purpura)
- Arm D only: requires ongoing treatment with warfarin or warfarin derivatives
- Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
- Clinically significant cardiovascular disease
- Prior malignancy within the past 3 years, except for curatively treated basal or squamous cell skin cancer, non-muscle-invasive bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score 6 prostate cancer
- History of severe bleeding disorder
- History of stroke or intracranial hemorrhage within 6 months before first dose of study drug
- Severe or debilitating pulmonary disease
- Unable to swallow capsules or disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedures, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction
The study team makes the final eligibility decision.
Where it's taking place
- Russian Federation
- Australia
- United Kingdom
- China
- New Zealand
- Taiwan
- 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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Russian Federation; Australia; United Kingdom; China; New Zealand; Taiwan and 1 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 EU CTIS; the study team decides eligibility.