Rituximab + Bendamustine +/- Brentuximab in CD30-Positive DLBCL
Research type
Research Study
Full title
A RANDOMIZED, OPEN LABEL, PHASE 2 STUDY OF RITUXIMAB AND BENDAMUSTINE WITH OR WITHOUT BRENTUXIMAB VEDOTIN FOR RELAPSED OR REFRACTORY CD30-POSITIVE DIFFUSE LARGE B CELL LYMPHOMA
IRAS ID
185205
Contact name
John Radford
Contact email
Sponsor organisation
Seattle Genetics Inc.
Eudract number
2015-001671-51
Clinicaltrials.gov Identifier
71634, IND number
Duration of Study in the UK
4 years, 0 months, 19 days
Research summary
This study will see if brentuximab vedotin, in combination with rituximab and bendamustine is more effective than the combination rituximab and bendamustine to treat diffuse large B-cell lymphoma (DLBCL).
Participants that fit the crteria will have received treatment before for their disease. Their cancer will have either returned or be non-responsive to treatment following:
i) Two or more treatment lines, the final one being classed as a second-line salvage therapy – a catch-all term to describe any therapy given to save the patient’s life;
OR
ii) After one line of treatment if the patient is not eligible to receive stem cell therapy.Approximately 110 participants aged 18 years or older will take part in this study at approximately 50 sites across the USA and Europe. Only participants whose disease expresses the tumour-marker CD30 protein on their tumour cells will be able to participate in this study: this will be confirmed during the screening process.
Participants will have an equal chance of being randomly assigned to either the control arm (rituximab and bendamustine) or the brentuximab vedotin treatment arm (brentuximab vedotin, rituximab and bendamustine). The study medications will be administered over six treatment cycles (about four months): each cycle is 21 days and will require 2-3 visits. If a participant assigned to the brentuximab vedotin treatment arm demonstrates they have responded to their study medication, the participant can continue to receive brentuximab vedotin as a single agent medication (i.e. without rituximab and bendamustine) for another 10 cycles (approximately 11 months in total), or until disease progression or unacceptable toxicity.
Once treatment in the study is completed, participants will return to the clinic for follow up assessments every 3 months for two years, every 6 months the following year, and annually thereafter.
REC name
East of England - Essex Research Ethics Committee
REC reference
15/EE/0326
Date of REC Opinion
2 Nov 2015
REC opinion
Further Information Favourable Opinion