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

NCT ID: NCT02569476

Last Updated: 2024-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-13
• Study Completion Date: 2020-09-02

Brief Summary

This study evaluated the safety and preliminary efficacy of BGB-3111 (zanubrutinib) in combination with obinutuzumab in participants with B-cell lymphoid malignancies.

Conditions

B-cell Lymphoid Malignancies

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Zanubrutinib and Obinutuzumab

In the dose-escalation part, dose levels and regimens were evaluated. In the indication-specific expansion cohorts, participants were assigned to different cohorts based on histology type.

Group Type: EXPERIMENTAL

Zanubrutinib

Intervention Type: DRUG

Obinutuzumab

Intervention Type: DRUG

Interventions

Zanubrutinib

Intervention Type: DRUG

Obinutuzumab

Intervention Type: DRUG

Other Intervention Names

BGB-3111

Eligibility Criteria

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/liter (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 and alanine transaminase ≤3 x ULN.
• Renal: Creatinine clearance ≥50 milliliters/minute (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 performance status of 0 to 2.
• Female participants of childbearing potential and non-sterile males must have agreed to practice at least one of the following methods of birth control with partner(s) throughout the study and for ≥3 months after discontinuing zanubrutinib or ≥18 months following obinutuzumab treatment, whichever was longer: total abstinence from sexual intercourse, double barrier contraception, intra uterine device or hormonal contraceptive initiated at least 3 months prior to first administration of study drug.
• Male participants must have not donated sperm from first study drug administration, until 3 months after zanubrutinib 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 Bruton tyrosine kinase inhibitor treatment.
• Used medications which were 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 had active graft versus host disease requiring ongoing immunosuppression.
• Receipt of the following treatment prior to first administration of zanubrutinib, corticosteroids given with anti-neoplastic intent within 7 days, chemotherapy or radiotherapy within 3 weeks, monoclonal antibody within 4 weeks.
• Participated 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, human T cell lymphotropic virus 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 have affected the safety of treatment or evaluation of any study's endpoints.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BeiGene

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: PRINCIPAL_INVESTIGATOR

BeiGene

Locations

Florida Cancer Specialists Fort Myers

Fort Myers, Florida, United States

Florida Cancer Specialists East

West Palm Beach, Florida, United States

Tennessee Oncology

Nashville, Tennessee, United States

St George Hospital

Kogarah, New South Wales, Australia

Brisbane Clinic For Lymphoma

Greenslopes, Queensland, Australia

Ashford Cancer Centre Research Northeast

Windsor Gardens, South Australia, Australia

St Vincents Hospital Melbourne

Fitzroy, Victoria, Australia

Barwon Health the Geelong Hospital

Geelong, Victoria, Australia

St Frances Xavier Cabrini Hospital

Malvern, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Royal Perth Hospital

Perth, Western Australia, Australia

Asan Medical Center

Seoul, Seoul Teugbyeolsi, South Korea

Gangnam Severance Hospital, Yonsei University Health System

Seoul, Seoul Teugbyeolsi, South Korea

Samsung Medical Center

Seoul, Seoul Teugbyeolsi, South Korea

Countries

United States; Australia; South Korea

References

Tam CS, Quach H, Nicol A, Badoux X, Rose H, Prince HM, Leahy MF, Eek R, Wickham N, Patil SS, Huang J, Prathikanti R, Cohen A, Elstrom R, Reed W, Schneider J, Flinn IW. Zanubrutinib (BGB-3111) plus obinutuzumab in patients with chronic lymphocytic leukemia and follicular lymphoma. Blood Adv. 2020 Oct 13;4(19):4802-4811. doi: 10.1182/bloodadvances.2020002183.

Reference Type: DERIVED

PMID: 33022066 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

BGB-3111_GA101_Study_001

Identifier Type: -

Identifier Source: org_study_id