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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.

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.

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: ACTIVE

Illinois

Chicago
Northwestern University
Status: CLOSED_TO_ACCRUAL

North Carolina

Durham
Duke University Medical Center
Status: ACTIVE

Texas

Houston
M D Anderson Cancer Center
Status: COMPLETED

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