BGB 3111 in Combination With Obinutuzumab in Participants With B-Cell Lymphoid Malignancies
Status and phase
Conditions
Treatments
Details and patient eligibility
About
This study evaluated the safety and preliminary efficacy of BGB-3111 (zanubrutinib) in combination with obinutuzumab in participants with B-cell lymphoid malignancies.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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Aged ≥18 years, able and willing to provide written informed consent and to comply with the study protocol.
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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.
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Anticipated survival of at least 6 months.
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Eastern Cooperative Oncology Group performance status of 0 to 2.
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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.
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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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
119 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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