A Randomised Phase II Trial of Inotuzumab Ozogamicin Plus Rituximab & CVP (IO-R-CVP) vs Gemcitabine Plus Rituximab & CVP (Gem-R-CVP) for the First Line Treatment of Patients With DLBCL Who Are Not Suitable for Anthracycline Containing Chemotherapy
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 (R-CVP) with the control arm of
gemcitabine added to the same combination (Gem-R-CVP).
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression free survival
Progression free survival rate and will be analysed using Kaplan-Meier survival analysis. PFS time will be measured from date of randomisation until progression or death.
At 2 years following date of randomisation.
Nottingham University Hospitals NHS Trust
United Kingdom: Medicines and Healthcare Products Regulatory Agency