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Trial Details
Trial status:
In follow-up (non-recruiting)
Recruitment start date:
01/08/2013
Funder:
Pfizer Limited
Sponsor:
UCL
Chief Investigator:
Dr Andrew McMillan
Recruitment target:
132
EudraCT number:
2012-001900-39
Contact details:
ctc.inca@ucl.ac.uk
Lay summary:
INCA
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
Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
NameVersionCurrent versRelease dateDownload
INCA Protocol v6.0 05.01.18_02112018_0.pdf6.0 Current 22/01/2018
Trial documents
NameTypeVersionCurrent versRelease dateDownload
INCA ICF v3.0 16.11.15_02112018_0.pdfInformedConsentForm3.0 Current 23/03/2016
PIS v6.0 05.01.18_02112018_0.pdfPatientInformationSheet6.0 Current 22/01/2018
Contact Us
Cancer Research UK & UCL Cancer Trials Centre
University College London
90 Tottenham Court Road
London
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Email:
ctc.enquiries@ucl.ac.uk
Telephone:
+44 (0)20 7679 9898 (General CTC Enquiries)
Fax:
020 7679 9899
University College London, Gower Street, London, WC1E 6BT +44 (0)20 7679 2000

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