Working… Menu

BGB 3111 in Combination With Obinutuzumab in Participants With B-Cell Lymphoid Malignancies

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. Read our disclaimer for details. Identifier: NCT02569476
Recruitment Status : Completed
First Posted : October 6, 2015
Last Update Posted : June 9, 2021
Information provided by (Responsible Party):

Brief Summary:
This study is evaluating the safety and preliminary efficacy of BGB-3111 in combination with obinutuzumab in subjects with B-cell lymphoid malignancies.

Condition or disease Intervention/treatment Phase
B-cell Lymphoid Malignancies Drug: BGB-3111 and Obinutuzumab Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 119 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b Study to Assess Safety, Tolerability and Antitumor Activity of the Combination of BGB 3111 With Obinutuzumab in Subjects With B-Cell Lymphoid Malignancies
Actual Study Start Date : January 13, 2016
Actual Primary Completion Date : September 2, 2020
Actual Study Completion Date : September 2, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: BGB-3111 and obinutuzumab
In the dose-escalation part, the dose levels and regimens will be evaluated. In the indication-specific expansion cohorts, patients will be assigned to different cohorts based on histology type.
Drug: BGB-3111 and Obinutuzumab

Primary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: From first dose to within 28 days of last dose of BGB-3111 ]

Secondary Outcome Measures :
  1. Area under the plasma concentration-time curve from time 0 to the time of the last measurable concentration (AUClast) [ Time Frame: the first 6 months ]
  2. Area under the plasma concentration-time curve from time 0 to infinity time (AUC∞) [ Time Frame: the first 6 months ]
  3. Maximum plasma concentration (Cmax) [ Time Frame: the first 6 months ]
  4. Terminal elimination half-life (t1/2) [ Time Frame: the first 6 months ]
  5. BTK inhibition activity of BGB-3111 by measurement of free BTK [ Time Frame: the first 6 months ]
  6. Tumor response [ Time Frame: Every 12 weeks from first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months ]

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.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Aged ≥18 years, able and willing to provide written informed consent and to comply with the study protocol.
  • Laboratory parameters as specified below:

    • Hematologic: Platelet count >40x10^9/L (may be post-transfusion); absolute neutrophil count >1.0x10^9/L (growth factor use is allowed to bring pre-treatment neutrophils to >1.0x10^9 cells/L if marrow infiltration is involved).
    • Hepatic: Total bilirubin <3 x upper limit normal (ULN); and aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤3xULN.
    • Renal: Creatinine clearance ≥50 mL/min (as estimated by the Cockcroft Gault equation or as measured by nuclear medicine scan or 24 hour urine collection); participants requiring hemodialysis will be excluded.
  • Anticipated survival of at least 6 months.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  • Female participants of childbearing potential and non-sterile males must agree to practice at least one of the following methods of birth control with partner(s) throughout the study and for ≥3 months after discontinuing BGB-3111 or ≥18 months following obinutuzumab treatment, whichever is longer: total abstinence from sexual intercourse, double barrier contraception, intra uterine device (IUD) or hormonal contraceptive initiated at least 3 months prior to first administration of study drug.
  • Male participants must not donate sperm from first study drug administration, until 3 months after BGB-3111 discontinuation or 18 months following obinutuzumab treatment, whichever is longer.

Exclusion Criteria:

  • Known central nervous system lymphoma or leukemia.
  • Known prolymphocytic leukemia or history of, or currently suspected, Richter's syndrome.
  • Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura.
  • History of significant cardiovascular disease.
  • Severe or debilitating pulmonary disease.
  • History of severe allergic or anaphylactic reactions to monoclonal antibody therapy.
  • Prior BTK inhibitor treatment.
  • Using medications which are strong cytochrome P450 (CYP) 3A inhibitors and strong CYP3A inducers.
  • Vaccination with a live vaccine within 28 days of the initiation of treatment.
  • Allogeneic stem cell transplantation within 6 months, or has active graft versus host disease (GvHD) requiring ongoing immunosuppression.
  • Receipt of the following treatment prior to first administration of BGB 3111, corticosteroids given with anti-neoplastic intent within 7 days, chemotherapy or radiotherapy within 3 weeks, monoclonal antibody within 4 weeks.
  • Participate in any investigational drug study within 28 days of study entry, or not recovered from non-hematologic toxicity of any prior chemotherapy up to ≤ Grade 1 (except for alopecia).
  • History of other active malignancies within 2 years of study entry.
  • Major surgery in the past 4 weeks.
  • Active symptomatic fungal, bacterial and/or viral infection including evidence of infection with human immunodeficiency virus (HIV), human T cell lymphotropic virus (HTLV 1) seropositive status.
  • Inability to comply with the study procedures.
  • Pregnant or nursing women.
  • Any illness or condition that in the opinion of the investigator may affect the safety of treatment or evaluation of any study's endpoints.

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 identifier (NCT number): NCT02569476

Layout table for location information
United States, Florida
Florida Cancer Specialists
Fort Myers, Florida, United States, 33916
Florida Cancer Specialists
Saint Petersburg, Florida, United States, 33705
United States, Tennessee
Tennessee Oncology, PLLC - Nashville
Nashville, Tennessee, United States, 37203
Australia, New South Wales
Border Medical Oncology
Albury, New South Wales, Australia, 2640
St George Hospital
Kogarah, New South Wales, Australia, 2217
Australia, Queensland
Brisbane Clinic for Lymphoma, Myeloma and Leukaemia
Greenslopes, Queensland, Australia, 4120
Australia, South Australia
Ashford Cancer Centre Research
Kurralta Park, South Australia, Australia, 5037
Australia, Victoria
St Vincent's Hospital Melbourne
East Melbourne, Victoria, Australia, 3002
University Hospital Geelong
Geelong, Victoria, Australia, 3220
St Frances Xavier Cabrini Hospital
Malvern, Victoria, Australia, 3144
The Alfred Hospital
Melbourne, Victoria, Australia, 3181
Australia, Western Australia
Royal Perth Hospital
Perth, Western Australia, Australia, 6000
Korea, Republic of
Severance Hospital, Yonsei University
Seoul, Korea, Republic of, 03722
Asan Medical Center
Seoul, Korea, Republic of, 05505
Samsung Medical Center
Seoul, Korea, Republic of, 06351
Sponsors and Collaborators
Layout table for investigator information
Study Director: William Reed, MD BeiGene
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: BeiGene Identifier: NCT02569476    
Other Study ID Numbers: BGB-3111_GA101_Study_001
First Posted: October 6, 2015    Key Record Dates
Last Update Posted: June 9, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by BeiGene:
Therapeutic uses
Additional relevant MeSH terms:
Layout table for MeSH terms
Antineoplastic Agents, Immunological
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action