A multicentre randomised phase II clinical trial of Inotuzumab Ozogamicin (INO) 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 (DLBCL) who
Description
Design:
INCA is a multicentre, randomised, phase II trial comparing IO-R-CVP with Gem-R-CVP in the first line treatment of patients with DLBCL who are not fit for anthracycline-containing chemotherapy.
Treatment:
All patients should receive steroids prior to randomisation into the trial. Patients will be randomised to receive either 6 cycles of IO-R-CVP (Inotuzumab Ozogamicin, Rituximab, Cyclophosphamide, Vincristine and Prednisolone) or GEM-R-CVP (Gemcitabine, Rituximab, Cyclophosphamide, Vincristine and Prednisolone). Patients are then followed up for a minimum of 2 years.
Key inclusion/exclusion criteria:
Patients must be 18 or above and have histologically proven DLBCL with demonstration of CD20 positivity. Patient must have bulky stage 1a-IV disease and be unsuitable for anthracycline containing chemotherapy due to impaired cardiac function or have a significant co-morbidity. Patients ECOG performance status must be 0-2 and they must have adequate bone marrow, liver and renal function. Patients can’t have CNS involvement, HIV or serological evidence of active Hepatitis B or Hepatitis C infection whether acute or chronic.
Duration of recruitment:
4 years
Aim
The overall aim is to determine the efficacy and safety of IO-R-CVP in patients with previously untreated DLBCL who are not-fit for anthracycline-containing chemotherapy