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A Study Comparing BGB-3111 With Bendamustine Plus Rituximab in Patients With Previously Untreated CLL or SLL

This study is currently recruiting participants.
Verified November 2017 by BeiGene
Sponsor:
ClinicalTrials.gov Identifier:
NCT03336333
First Posted: November 8, 2017
Last Update Posted: November 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
BeiGene
  Purpose
This study will enroll subjects with previously untreated CLL/SLL into two cohorts (Cohort 1 without del[17p] and Cohort 2 with del[17p]). Cohort 1 subjects will receive either "BGB-3111 alone" or "bendamustine (B) and rituximab (R)". Cohort 2 subjects will receive BGB-3111 alone. The primary purpose is to evaluate the efficacy and safety of BGB-3111 versus bendamustine and rituximab in Cohort 1.

Condition Intervention Phase
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma Drug: BGB-3111 Drug: Bendamustine Drug: Rituximab Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An International, Phase 3, Open-Label, Randomized Study of BGB-3111 Compared With Bendamustine Plus Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL)

Resource links provided by NLM:


Further study details as provided by BeiGene:

Primary Outcome Measures:
  • Progression-free survival between treatment groups in Cohort 1 (BGB-3111 vs. bendamustine plus rituximab) as determined by independent central review [ Time Frame: From randomization to the date of first documentation of disease progression or death, whichever occurs first, assessed up to 5 years. ]

Secondary Outcome Measures:
  • Overall response rate between treatment groups in Cohort 1 as determined by independent central review and by investigator assessment. [ Time Frame: From time of best response recorded from randomization until data cut or start of new anticancer treatment, assessed up to 5 years. ]
  • Overall survival between treatment groups in Cohort 1 [ Time Frame: From time of randomization until date of death due to any reason, assessed up to 5 years. ]
  • Duration of response between treatment groups in Cohort 1 determined by independent central review and by investigator assessment [ Time Frame: From date that response criteria are first met to the date of first documentation of disease progression or death, whichever occurs first, assessed up to 5 years. ]
  • Progression-free survival between treatment groups in Cohort 1 determined by investigator assessment [ Time Frame: From randomization to the date of first documentation of disease progression or death, whichever occurs first, assessed up to 5 years. ]
  • Overall response rate in Cohort 2 as determined in independent central review [ Time Frame: From time of best response recorded from randomization until data cut or start of new anticancer treatment, assessed up to 5 years. ]
  • Overall survival in Cohort 2 [ Time Frame: From time of first BGB-3111 dose administration until date of death due to any reason, assessed up to 5 years. ]
  • Progression-free survival in Cohort 2 determined by independent central review [ Time Frame: From the date of first BGB-3111 dose administration to the date of first documentation of disease progression or death, whichever occurs first, assessed up to 5 years. ]
  • Duration of response in Cohort 2 determined by independent central review [ Time Frame: From date that response criteria are first met to the date of first documentation of disease progression or death whichever occurs first, assessed up to 5 years. ]
  • Incidence, nature and severity of adverse events between treatment groups in Cohort 1 [ Time Frame: From date of first study drug dose to approximately 30 days after end of treatment ]

Estimated Enrollment: 467
Actual Study Start Date: November 2, 2017
Estimated Study Completion Date: October 2022
Estimated Primary Completion Date: September 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BGB-3111 (patients without del[17p])
Approximately 210 subjects in Cohort 1 to receive BGB-3111
Drug: BGB-3111
BGB-3111 will be administered as two 80-mg capsules by mouth twice a day (160 mg twice a day)
Experimental: B+R
Approximately 210 subjects in Cohort 1 to receive bendamustine plus rituximab
Drug: Bendamustine
Bendamustine will be administered intravenously at a dose of 90 mg/m2/day on the first 2 days of each cycle for 6 cycles. 1 cycle = 28 days.
Other Name: Treanda, Ribomustin, and Levact
Drug: Rituximab
Rituximab will be administered intravenously at a dose of 375 mg/m2 on day 0 of cycle 1, and at a dose of 500 mg/m2 on day 1 of cycles 2 to 6. 1 cycle = 28 days.
Other Name: Rituxan, MabThera
Experimental: BGB-3111 patients with del[17p])
Approximately 47 subjects in Cohort 2 to receive BGB-3111
Drug: BGB-3111
BGB-3111 will be administered as two 80-mg capsules by mouth twice a day (160 mg twice a day)

Detailed Description:
This is a global phase 3, open label, randomized study of BGB-3111 versus bendamustine plus rituximab (B+R) in subjects with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL), including subjects without del(17p) [Cohort 1] and subjects with del(17p) [Cohort 2]. Subjects in Cohort 1 are randomized 1:1 to BGB-3111 (Arm A) or bendamustine plus rituximab (Arm B). Randomization will be stratified by age, Binet stage, immunoglobulin variable region heavy chain (IGHV) mutational status, and geographic region. Subjects in Cohort 2 receive treatment with BGB-3111.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: All subjects

  1. Unsuitable for chemoimmunotherapy with FCR in the opinion of the investigator.
  2. Confirmed diagnosis of CD20-positive CLL or SLL.
  3. Binet Stage C disease, or Binet Stage B or A disease requiring treatment.
  4. ECOG performance status of 0, 1 or 2.
  5. Life expectancy ≥ 6 months.
  6. Adequate bone marrow function.
  7. Adequate renal and hepatic function.
  8. Females of childbearing potential and non-sterile males must agree to use highly effective methods of birth control throughout the course of study
  9. Male patients are eligible if vasectomized or if they agree to use of barrier contraception with other methods described above throughout the course of study.
  10. Written informed consent.

Exclusion Criteria: All subjects

  1. Previous systemic treatment for CLL/SLL.
  2. Known prolymphocytic leukemia or history of or 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 of breast.
  5. Major surgery or significant injury ≤ 4 weeks prior to start of study treatment.
  6. History of severe bleeding disorder.
  7. History of stroke or intracranial hemorrhage within 6 months before the first dose of study drug.
  8. Severe or debilitating pulmonary disease.
  9. Inability to swallow capsules or disease affecting gastrointestinal function.
  10. Known central nervous system involvement by leukemia or lymphoma.
  11. Active infection requiring systemic treatment.
  12. Known infection with human immunodeficiency virus (HIV) or active hepatitis B or C infection.
  13. Vaccination with live vaccine within 35 days prior to the first dose of study drug.
  14. Known hypersensitivity to BGB-3111, bendamustine, or rituximab or any other ingredients of the study drugs.
  15. Requires ongoing treatment with strong CYP3A inhibitor or inducer.
  16. Pregnant or nursing females.
  17. Concurrent participation in another therapeutic clinical trial.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03336333


Contacts
Contact: Aileen Cohen, MD 781-801-1800 clinicaltrials@beigene.com
Contact: Carol Marimpietri, RN 781-801-1800 clinicaltrials@beigene.com

Locations
United States, Nevada
Comprehensive Cancer Centers of Nevada Recruiting
Las Vegas, Nevada, United States, 89014
Contact: Edwin Kingsley, MD         
Principal Investigator: Edwin Kingsley, MD         
Belgium
Centre Not yet recruiting
Brussel, Belgium
Principal Investigator: pierre gould, md         
Sponsors and Collaborators
BeiGene
  More Information

Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT03336333     History of Changes
Other Study ID Numbers: BGB-3111-304
First Submitted: November 1, 2017
First Posted: November 8, 2017
Last Update Posted: November 9, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by BeiGene:
BGB-3111
BTK inhibitor
bendamustine
rituximab
Phase 3

Additional relevant MeSH terms:
Lymphoma
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Rituximab
Bendamustine Hydrochloride
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action