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Trial Details
Trial status:
Closed
Recruitment start date:
19/07/2006
Funder:
Cancer Research UK
Sponsor:
LYSA
Chief Investigator:
Professor David Linch
Recruitment target:
480
EudraCT number:
2004-002103-32
Contact details:
ctc.bnli@ucl.acuk
Lay summary:
CORAL
Randomised study of ICE + Rituximab (R-ICE) versus DHAP Rituximab (R-DHAP) in previously treated patients with CD20 positive diffuse large B-cell Non-Hodgkins lymphoma, eligible for high dose chemotherapy followed by randomised maintenance treatment with Rituximab
Description
Design: CORAL is a multicentre, phase III open-label, randomized trial evaluating the efficacy of R-ICE compared to R-DHAP with previously treated diffuse large B-cell lymphoma, followed by high-dose chemotherapy +/- rituximab maintenance therapy. 
Treatment: Patients will be randomised to receive either 3 cycles of R-ICE or 3 cycles of R-DHAP.  All patients will then be mobilised with G-CSF for peripheral blood stem cell collection.  Patients that are in CR, Cru or PR after treatment will be submitted to consolidation with R-Beam.  Prior to transplant, patients will be randomised for a 2nd time to either Rituximab maintenance (every 8 weeks for a maximum of 6 cycles) or observation.
Key inclusion/exclusion criteria: Patients must be 18-65 and have histologically proven CD20+ diffuse large B-cell lymphoma.  Patients must be in first relapse after CR, less than PR or partial response to first line treatment not achieving documented or confirmed complete remission.  Patient must be eligible for a transplant and previously treated with a chemotherapy regimen containing anthracyclines with or without rituximab.  Patients can’t be HIV positive or have HBV.  Patients can’t have history of cancer during the last 5 years with the exception of non-melanoma skin tumours or stage 0 (in situ) cervical carcinoma.
Duration of recruitment: 5 years
Aim
The aim of this trial is to evaluate the efficacy and the safety of induction therapy: ICE plus rituximab (R-ICE) in comparison with DHAP plus rituximab (R-DHAP) in patients previously treated with CD20-positive large B-cell lymphoma eligible for autologous transplantation.  It will also evaluate the efficacy and safety of rituximab maintenance therapy after transplantation.
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.
No protocols have been currently made available for download
Trial documents
No documents have been currently made available for download
Contact Us
Cancer Research UK & UCL Cancer Trials Centre
University College London
90 Tottenham Court Road
London
W1T 4TJ

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Email:
ctc.enquiries@ucl.ac.uk
Telephone:
+44 (0)20 7679 9898 (General CTC Enquiries)
Fax:
020 7679 9899
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