A Study Comparing Obinutuzumab and BGB-3111 Versus Obinutuzumab Alone in Treating R / R Follicular Lymphoma
Trial Status: Active
The purpose of the study is to evaluate the efficacy, safety and tolerability and of BGB-3111 plus obinutuzumab versus obinutuzumab alone in participants with relapsed / refractory non-Hodgkin follicular lymphoma.
- Histologically confirmed diagnosis of B-cell follicular lymphoma
- ≥2 prior systemic treatments for follicular lymphoma.
- Previously received an anti-CD20 antibody and an appropriate alkylator-based combination therapy.
- Disease progression after completion of most recent therapy or refractory disease.
- Presence of measurable disease.
- Availability of archival tissue confirming diagnosis.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2.
- Adequate renal and hepatic function.
- Prior exposure to a Bruton's tyrosine kinase (BTK) inhibitor.
- Known central nervous system involvement by leukemia or lymphoma.
- Evidence of transformation from follicular lymphoma to other aggressive histology.
- Allogeneic hematopoietic stem cell transplantation within 12 months of enrollment
- Prior malignancy within the past 2 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix of breast, or localized Gleason score 6 prostate
- Clinically significant cardiovascular disease.
- Major surgery or significant injury ≤ 4 weeks prior to start of study treatment.
- Active fungal, bacterial or viral infection requiring systemic treatment.
- History of severe bleeding disorder.
Emory University Hospital / Winship Cancer Institute
Duke University Medical Center
M D Anderson Cancer Center
Trial Phase Phase II
Trial Type Treatment
BeiGene Company Limited
- Primary ID BGB-3111-212
- Secondary IDs NCI-2018-01020, 2017-001552-54, BGB-3111-212 (Rosewood)
- Clinicaltrials.gov ID NCT03332017