Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18+
Trial acronym
BGB-3111_001
Clinical summary
Summary
This study is evaluating the safety and preliminary efficacy of BGB-3111 in combination with obinutuzumab in subjects with B-cell lymphoid malignancies.
Conditions
This trial is treating people with B-Cell Non Hodgkin Lymphoma
Eligibility
Exclusion
- 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.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
- You are currently being treated on a clinical trial.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
BeiGene Australia Pty Ltd
Scientific 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
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