A Phase 3 Study of BGB-3111 Compared with Bendamustine plus Rituximab in Patients with Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 467

Inclusion Criteria

1. Unsuitable for chemoimmunotherapy with FCR in the opinion of the investigator
2. Confirmed diagnosis of CD20-positive CLL or SLL that meets the CLL criteria (Hallek et al, 2008)
3. Binet Stage C disease, or Binet Stage B or A disease requiring treatment as defined by at least one of the criteria (Hallek et al, 2008)
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
5. Life expectancy = 6 months
6. Adequate bone marrow function
7. Patient must have adequate organ function
8. 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 BGB-3111, 3 months after the last dose of bendamustine, or 12 months after the last dose of rituximab, whichever is longer.
9. 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 BGB-3111 or 3 months after the last dose of bendamustine whichever is longer.
10. Ability to provide written informed consent and can understand and comply with the requirements of the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 93
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 374

Exclusion Criteria

1. Previous systemic treatment for CLL/SLL
2. Known prolymphocytic leukemia or history of, or currently suspected, Richter’s transformation
3. Clinically significant cardiovascular disease
4. Prior malignancy within the past 3 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast
5. History of severe bleeding disorder
6. History of stroke or intracranial hemorrhage within 6 months before first dose of study drug
7. Severe or debilitating pulmonary disease
8. 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
9. Active fungal, bacterial and/or viral infection requiring systemic therapy
10. Known central nervous system involvement by leukemia or lymphoma
11. 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
12. Known infection with HIV, or serologic status reflecting active hepatitis B or C infection
13. Major surgery within 4 weeks of the first dose of study drug
14. Pregnant or lactating women
15. Vaccination with a live vaccine within 35 days prior to the first dose of study drug
16. Ongoing alcohol or drug addiction
17. Hypersensitivity to BGB-3111, bendamustine, or rituximab or any of the other ingredients of the study drugs
18. Requires ongoing treatment with a strong CYP3A inhibitor or inducer
19. Concurrent participation in another therapeutic clinical trial.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Updated 10/17/2023

A Phase 3 Study of BGB-3111 Compared with Bendamustine plus Rituximab in Patients with Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Recruitment & Eligibility

Study & Design

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