A Study Comparing Obinutuzumab and BGB-3111 Versus Obinutuzumab Alone in Treating R / R Follicular Lymphoma

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
BeiGene Company Limited

• Primary ID BGB-3111-212
• Secondary IDs NCI-2018-01020, 2017-001552-54, BGB-3111-212 (Rosewood)
• Clinicaltrials.gov ID NCT03332017