BGB3111_212 (FL) : An International, Phase 2, Open-Label, Randomized Study of BGB-3111 Combined With Obinutuzumab Compared With Obinutuzumab Monotherapy in Relapsed/ Refractory Follicular Lymphoma

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

TwoPhase Two

18-99Age 18-99

Blood<br/>CancersCancer LocationBlood
Cancers

Systemic therapy | Blood / Myeloma / LymphomaFollicular Lymphoma

Trial Overview Read MoreRead more

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 gotten worse or not responded to prior treatment.
 

This trial is treating patients with Follicular Lymphoma.

This is a systemic therapy trial.

You may be able to join this trial if:

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

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • 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 - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

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

Commercial Sponsor

BeiGene Australia Pty Ltd

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.

Recruiting Hospitals Read MoreRead more

Monash Health Haematology Research Unit
Clayton
Ms Anita Cummins
anita.cummins@southernhealth.org.au
03 9594 4044

Peninsula Private Hospital
Frankston
Jodie Wainwright
WainwrightJ@ramsayhealth.com.au
03 9788 3647

St Vincent's Hospital, Haematology Oncology Research
Fitzroy
Ms Lisa Demosthenous
lisa.demosthenous@svha.org.au
03 9231 3182

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

Next