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Closed (no longer recruiting)Last updated: 18 January 2024

BGB3111_212 (FL): This phase II trial is evaluating Obinutuzumab alone and in combination with a new oral drug (BGB-3111) for the treatment of non-Hodgkin follicular lymphoma that has got worse or not responded to prior treatmentAn International, Phase 2, Open-Label, Randomized Study of BGB-3111 Combined With Obinutuzumab Compared With Obinutuzumab Monotherapy in Relapsed/ Refractory Follicular Lymphoma

Clinical summary


This is an open-label, randomized active control study of BGB-3111 plus obinutuzumab versus obinutuzumab alone in subjects with relapsed or refractory follicular lymphoma. Randomization is 2:1 and subjects will be stratified by the number of prior lines of therapy (2 - 3 vs > 3) and rituximab-refractory status. In Arm A of the study, approximately 140 subjects will receive an oral 80mg dose of BGB-3111 twice a day and 1000mg of Obinutuzumab, administered intravenously on days 1, 8 and 15 of the cycle, followed by 1,000 mg on day 1 of cycles 2 to 6, then 1,000 mg every 8 weeks. In Arm B, 70 patients will receive Obinutuzumab alone. For both groups, 1 cycle = 28 days. The study will evaluate the efficacy, as measured by overall response rate by independent review, safety and tolerability. Pharmacokinetic profile of BGB-3111 and obinutuzumab combination therapy will also be evaluated.


This trial is treating patients with Follicular Lymphoma.


Blood Cancers Haematological


People18 - 99



Trial Acronym

BGB3111_212 (FL)

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Trial sponsor

BeiGene Australia Pty Ltd

Scientific Title

An International, Phase 2, Open-Label, Randomized Study of BGB-3111 Combined With Obinutuzumab Compared With Obinutuzumab Monotherapy in Relapsed/ Refractory Follicular Lymphoma



  1. Histologically confirmed diagnosis of B-cell follicular lymphoma
  2. ≥2 prior systemic treatments for follicular lymphoma.
  3. Previously received an anti-CD20 antibody and an appropriate alkylator-based combination therapy.
  4. Disease progression after completion of most recent therapy or refractory disease.
  5. Presence of measurable disease.
  6. Availability of archival tissue confirming diagnosis.
  7. Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2.
  8. Adequate renal and hepatic function.


  1. Prior exposure to a Bruton's tyrosine kinase (BTK) inhibitor.
  2. Known central nervous system involvement by leukemia or lymphoma.
  3. Evidence of transformation from follicular lymphoma to other aggressive histology.
  4. Allogeneic hematopoietic stem cell transplantation within 12 months of enrollment
  5. 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
  6. Clinically significant cardiovascular disease.
  7. Major surgery or significant injury ≤ 4 weeks prior to start of study treatment.
  8. Active fungal, bacterial or viral infection requiring systemic treatment.
  9. History of severe bleeding disorder.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.


  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.


  • 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 have previously been treated (or are currently being treated) on a clinical trial.

Clinical trials have complex eligibility criteria.

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