INCA
Research type
Research Study
Full title
A multicentre randomised phase II clinical trial of Inotuzumab Ozogamicin plus Rituximab and CVP (IO-R-CVP) versus Gemcitabine plus Rituximab and CVP (Gem-R-CVP) for the first line treatment of patients with diffuse large B cell lymphoma who are not suitable for anthracycline containing chemotherapy
IRAS ID
106985
Contact name
Andrew McMillan
Sponsor organisation
University College London
Eudract number
2012-001900-39
Clinicaltrials.gov Identifier
Research summary
The aim is to determine the efficacy and safety of adding inotuzumab ozogamicin to R-CVP in the first line treatment of Diffuse Large B Cell Lymphoma in patients who are not able to receive anthracycline containing immunochemotherapy. The incidence of DLBCL is increasing and with an expanding elderly population, the incidence will continue to rise. Given that about 40% of cases of DLBCL occur in patients aged over 70 and the number of co-mobilities increases with age, research to investigate the optimal treatment of DLBCL in this group of patients is needed. R-CHOP remains the standard of care for the majority of patients with DLBCL, anthracycline use is precluded in a proportion of these patients by a high risk of developing cardiotoxicity, especially congestive cardiac failure. Currently there is no standard of care for patients who are unfit for anthracycline treatment. It has been routine to omit the doxorubicin from R-CHOP, giving R-CVP instead. However the outcome for patients treated with R-CVP is poor and attempts have been made to replace the doxorubicin with alternative agents. The trial will compare an experimental arm consisting of Inotuzumab Ozogamicin added to the standard immunochemotherapy regimen of rituximab, cyclophosphamide, vincristine and prednisolone (IO-R-CVP) with the control arm of gemcitabine added to the same combination (Gem-R-CVP).Patients will be identified, consented and treated at sites throughout the UK. All patients will receive a steroid pre-phase. Those patients who have an ECOG performance status 0-2 after steroid pre-phase will be randomised to either Gem-R-CVP or IO-R-CVP for a maximum of 6 cycles followed by 2 further doses of Rituximab. If demonstrated to be efficacious and safe to deliver, the IO-R-CVP regimen will be tested in a phase III trial to determine whether this should become the standard of care amongst patients with DLBCL not fit for anthracylines.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
12/YH/0452
Date of REC Opinion
1 Nov 2012
REC opinion
Further Information Favourable Opinion