GO43878 (GLOBRYTE): Glofitamab in Mantle Cell Lymphoma

• Research type

  Research Study

• Full title

  A PHASE III, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY EVALUATING GLOFITAMAB AS A SINGLE AGENT VERSUS INVESTIGATOR’S CHOICE IN PATIENTS WITH RELAPSED/REFRACTORY MANTLE CELL LYMPHOMA

• IRAS ID

  1008010

• Contact name

  Abira Suganthan

• Contact email

  welwyn.uk_ethics@roche.com

• Sponsor organisation

  F. Hoffmann-La Roche AG

• Clinicaltrials.gov Identifier

  NCT06084936

• Research summary

  This is a randomized controlled trial in patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL). The aim of the study is to evaluate the effects (good or bad) and safety of a drug called glofitamab and compare how well it works vs standard treatment in people with R/R MCL.
  Glofitamab is a novel T-cell bispecific antibody. It attaches to a protein called CD20 found on some types of MCL cells and can join to another protein on cancer-killing immune system cells. This brings them closer together, so immune cells destroy the MCL cells. Glofitamab is approved for the treatment of adult patients with some types of lymphoma.
  People can take part in this trial if they are at least 18 years old and have previously treated MCL. People can take part if they have been given at least one treatment including a BTK inhibitor and systemic treatment combination.
  There are two treatment groups in this study. The treatment group will be decided by chance (like tossing a coin). There is an equal chance of being placed in either group.
  Participants in the experimental group will receive glofitamab (experimental arm) following pretreatment with a drug called obinutuzumab.
  Participants in the control group will receive either bendamustine + rituximab or rituximab + lenalidomide. The treatment options in the control group are widely used for this type of cancer. The choice of treatment in the control group will be determined by the study doctor.
  At the end of their treatment patients in the control group will be given the option to receive glofitamab.
  The total duration of study participation for each individual is expected to range from 1 day to more than 24 months.
  Participants can stop trial treatment and leave the trial at any time.
  Approximately 12 participants will take part in the study in the UK; 182 worldwide

• REC name

  London - City & East Research Ethics Committee

• REC reference

  23/LO/0582

• Date of REC Opinion

  5 Sep 2023

• REC opinion

  Further Information Favourable Opinion