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Trial Details
Trial status:
Closed
Recruitment start date:
14/03/2005
Funder:
Chugai Pharma UK Ltd
Sponsor:
UCL
Chief Investigator:
Prof David Cunningham
Recruitment target:
1204
EudraCT number:
2004-002197-34
Contact details:
ctc.r-chop@ucl.ac.uk
Lay summary:
R-CHOP 14 vs 21
A phase III multicentre randomised clinical trial comparing rituximab with CHOP given every 14 days and rituximab with CHOP given every 21 days for the treatment of patients with newly diagnosed diffuse large B cell non-Hodgkin’s lymphoma.
Description
Design: A multicentre randomised trial comparing R-CHOP 14 given for 6 cycles with R-CHOP 21 given for 8 cycles in patients with newly diagnosed CD20 positive diffuse large B cell lymphoma, bulky stage IA to IV and no cardiac contra-indication to doxorubicin
Treatment:
Experimental arm
R-CHOP 14 (cycle repeats every 14 days for 6 cycles)
Rituximab: 375mg/m2 iv day 1
Cyclophosphamide: 750mg/m2 iv day 1
Doxorubicin: 50mg/m2 iv day 1
Vincristine: 2mg iv day 1
Prednisolone: 100 mg po days 1 to 5
Lenograstim: 263-368g once daily sc days 4-12

Control arm
R-CHOP 21 (cycle repeats every 21 days for 6 cycles) + Rituximab given for 2 further cycles.
Rituximab: 375mg/m2 iv day 1 
Cyclophosphamide: 750mg/m2 iv day 1
Doxorubicin: 50mg/m2 iv day 1
Vincristine: 1.4mg/m2 iv day 1
Prednisolone: 40mg/m2 po days 1 to 5

Key inclusion/exclusion criteria:
  • Patients with histological diagnosis of diffuse large B-cell lymphoma according to the World Health Organisation classification whatever the subtype. The B-cell nature of the proliferation must have been verified by the positivity with an anti-CD20 antibody before randomisation 
  • Not previously treated
  • Bulky stage IA to IV

Duration of recruitment: 4 years 
Aim
To evaluate the improvement in overall survival of rituximab combined with CHOP given every 14 days (R-CHOP 14) in comparison to rituximab with CHOP given every 21 days (R-CHOP 21).
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
Buccal Smear sub study Protocol_v1.0_24.03.20061.0 Current 24/03/2006
PET sub study Protocol_v6.0_17.03.20116.0 Current 17/03/2011
Protocol (main trial)_v9.0_29.02.20169.0 Current 29/02/2016
PET sub study Protocol_v2.0_July.20062.0 Historic 01/07/2006
PET sub study Protocol_v2.1_Sep.20062.1 Historic 01/09/2006
PET sub study Protocol_v3.0_26.07.20073.0 Historic 26/07/2007
PET sub study Protocol_v4.0_18.07.20084.0 Historic 18/07/2008
PET sub study Protocol_v5.0_30.03.20105.0 Historic 30/03/2010
Protocol (main trial)_v3.0_13.07.20063.0 Historic 13/07/2006
Protocol (main trial)_v3.1_14.09.20063.1 Historic 14/09/2006
Protocol (main trial)_v4.0_03.04.20074.0 Historic 03/04/2007
Protocol (main trial)_v5.0_07.07.20085.0 Historic 07/07/2008
Protocol (main trial)_v6.0_30.03.20106.0 Historic 30/03/2010
Protocol (main trial)_v7.0_17.03.20117.0 Historic 17/03/2011
Protocol (main trial)_v8.0_19.10.20128.0 Historic 19/10/2012
Trial documents
NameTypeVersionCurrent versRelease dateDownload
Consent Form (Registration) Main Study_v5.0_30.03.2010InformedConsentForm5.0 Current 30/03/2010
Consent Form (Registration) PET Substudy_v4.0_30.03.2010InformedConsentForm4.0 Current 30/03/2010
Consent Form Buccal Smear Substudy_v2.0_01.10.2006InformedConsentForm2.0 Current 01/10/2006
CRF: All forms_v4.3_15.04.2007CRF4.3 Current 15/04/2007
CRF: Follow up/Progression/Death forms_v4.3_15.04.2007CRF4.3 Current 15/04/2007
CRF: Guidance Notes_v2.1_15.04.2007CRF2.1 Current 15/04/2007
CRF: Registration Form_v7.0_29.10.2010CRF7.0 Current 29/10/2010
CTCAE_v3.0GuidanceDdocument3.0 Current
Declaration of the End of Trial Form to MHRA_14.09.2018OtherN/A Current 14/09/2018
Declaration of the End of Trial Form to REC_03.02.2017 OtherN/A Current 03/02/2017
GP letter (Registration)_v4.2_15.07.2011GPletter4.2 Current 15/07/2011
Investigator Brochure- Mabthera_v14.0_May2009Other14 Current 01/05/2009
MREC approval for Amendment 10.03.16 (MAIN protocol v9.0)_22.07.2016(revised)Amendment10.03.2016 Current 22/07/2016
Original MHRA approval letterOtherInitial Current 13/10/2004
Original REC approval letterOtherInitial Current 18/05/2004
Patient Enrolment Log/Master subject List_v1.0_24.01.2011TrialsLog1.0 Current 24/01/2011
Patient Information Sheet (Registration) Main Study_v5.0_30.03.2010PatientInformationSheet5.0 Current 30/03/2010
Patient Information Sheet (Registration) Pet substudy_v4.0_30.03.2010PatientInformationSheet4.0 Current 30/03/2010
Patient Information Sheet Buccal Smear substudy_v2.0_01.10.2006PatientInformationSheet2.0 Current 01/10/2006
SAE Report Additional Pages_v1.0_13.10.2010SAEform1.0 Current 13/10/2010
SAE Report_v2.0_05.09.2008SAEform2.0 Current 05/09/2008
SmPC- CyclophosphamideOtherN/A Current 01/08/2007
SmPC- DoxorubicinOtherN/A Current 05/01/2010
SmPC- Lenograstim OtherN/A Current 01/05/2009
SmPC- PrednisoloneOtherN/A Current 15/09/2008
SmPC- VincristineOtherN/A Current 02/12/2008
UCL Sponsorship letter_17.10.2004OtherN/A Current 17/10/2004
Consent Form (Registration) Main Study_v1.0_28.04.2004InformedConsentForm1.0 Historic 28/04/2004
Consent Form (Registration) Main Study_v2.0_03.08.2005InformedConsentForm2.0 Historic 03/08/2005
Consent Form (Registration) Main Study_v3.0_26.07.2007InformedConsentForm3.0 Historic 26/07/2007
Consent Form (Registration) Main Study_v4.0_07.07.2018InformedConsentForm4.0 Historic 07/07/2008
Consent Form (Registration) PET Substudy_v1.0_01.04.2006InformedConsentForm1.0 Historic 01/04/2006
Consent Form (Registration) PET Substudy_v2.0_26.07.2007InformedConsentForm2.0 Historic 26/07/2007
Consent Form (Registration) PET Substudy_v3.0_18.07.2008InformedConsentForm3.0 Historic 18/07/2008
Consent Form Buccal Smear Substudy_v1.0_24.03.06InformedConsentForm1.0 Historic 24/03/2006
CRF: All forms_v4.0_09.03.2005CRF4.0 Historic 09/03/2005
CRF: All forms_v4.1_29.06.2005CRF4.1 Historic 29/06/2005
CRF: All forms_v4.2_18.09.2006CRF4.2 Historic 18/09/2006
CRF: Guidance Notes_v1.0_09.03.2005CRF1.0 Historic 09/03/2005
CRF: Guidance Notes_v2.0_18.09.2006CRF2.0 Historic 18/09/2006
CRF: Registration Form_v4.0_09.03.2005CRF4.0 Historic 09/03/2005
CRF: Registration Form_v4.1_29.06.2005CRF4.1 Historic 29/06/2005
CRF: Registration Form_v4.2_18.09.2006CRF4.2 Historic 18/09/2006
CRF: Registration Form_v4.3_15.04.2007CRF4.3 Historic 15/04/2007
CRF: Registration Form_v5.0_31.07.2008CRF5.0 Historic 31/07/2008
CRF: Registration Form_v6.0_17.11.2008CRF6.0 Historic 17/11/2008
GP letter (Registration)_v1.0_28.04.2004GPletter1.0 Historic 28/04/2004
GP letter (Registration)_v2.0_03.08.2005GPletter2.0 Historic 03/08/2005
GP letter (Registration)_v3.0_07.07.2008GPletter3.0 Historic 07/07/2008
GP letter (Registration)_v4.0_30.03.2010GPletter4.0 Historic 30/03/2010
GP letter (Registration)_v4.1_26.10.2010GPletter4.1 Historic 26/10/2010
Investigator Brochure- Mabthera_v11.0_Nov2006Other11.0 Historic 01/11/2006
Investigator Brochure- Mabthera_v12.0_Jan2007Other12.0 Historic 29/01/2007
Investigator Brochure- Mabthera_v13.0_Jan2008Other13.0 Historic 01/01/2008
Investigator Brochure- Mabthera_v9.0_Jun2004Other9.0 Historic 01/06/2004
MHRA approval for Amendment 04.08.05 (Main Protocol v2.0)_08.08.2005Amendment04.08.2005 Historic 08/08/2005
MHRA approval for Amendment 26.07.07 (MAIN Protocol v4.0)_28.08.2007Amendment26.07.2007 Historic 28/08/2007
MHRA approval for Amendment 26.08.08 (MAIN protocol v5.0)_06.10.2008Amendment26.08.2008 Historic 06/10/2008
MHRA approval for Amendment 29.10.12 (Main Protocol v8.0)_11.12.2012Amendment29.10.2012 Historic 11/12/2012
MHRA approval for Amendment 30.03.10 (MAIN protocol v 6.0)_13.05.2010Amendment30.03.2010 Historic 13/05/2010
MHRA approval for Amendment 31.07.06 (MAIN protocol v3.0)_24.08.2006Amendment31.07.2006 Historic 24/08/2006
MREC approval for Amendment 04.08.05 (Main protocol v2.0)_24.08.2005Amendment04.08.2005 Historic 24/08/2005
MREC approval for Amendment 10.03.16 (MAIN protocol v9.0)_23.03.2016Amendment10.03.2016 Historic 23/03/2016
MREC approval for Amendment 15.07.11 (GP Letter v4.2)_27.07.2011Amendment15.07.2011 Historic 27/07/2011
MREC approval for Amendment 17.01.11 (GP Letter v4.1)_31.01.2011Amendment17.01.2011 Historic 31/01/2011
MREC approval for Amendment 17.03.11 (MAIN protocol v7.0/PET protocol v6.0)_27.04.2011Amendment17.03.2011 Historic 27/04/2011
MREC approval for Amendment 26.07.07 (MAIN Protocol v4.0)_23.08.2007Amendment26.07.2007 Historic 23/08/2007
MREC approval for Amendment 26.08.08 (MAIN protocol v5.0)_18.09.2008Amendment26.08.2008 Historic 18/09/2008
MREC approval for Amendment 29.10.12 (MAIN protocol v8.0)_27.11.2012Amendment29.10.2012 Historic 27/11/2012
MREC approval for Amendment 30.03.10 (MAIN protocol v 6.0)_22.04.2010Amendment30.03.2010 Historic 22/04/2010
MREC approval for Amendment 31.07.06 (Main protocol v3.0)_30.08.2006Amendment31.07.2006 Historic 30/08/2006
Patient Information Sheet (Registration) Main Study_v1.0_28.04.2004PatientInformationSheet1.0 Historic 28/04/2004
Patient Information Sheet (Registration) Main Study_v2.0_26.07.2007PatientInformationSheet2.0 Historic 26/07/2007
Patient Information Sheet (Registration) Main Study_v3.0_26.07.2007PatientInformationSheet3.0 Historic 26/07/2007
Patient Information Sheet (Registration) Main Study_v4.0_07.07.2008PatientInformationSheet4.0 Historic 07/07/2008
Patient Information Sheet (Registration) Pet substudy_v1.0_01.04.2006PatientInformationSheet1.0 Historic 01/04/2006
Patient Information Sheet (Registration) Pet substudy_v2.0_26.07.2007PatientInformationSheet2.0 Historic 26/07/2007
Patient Information Sheet (Registration) Pet substudy_v3.0_18.07.2008PatientInformationSheet3.0 Historic 18/07/2008
Patient Information Sheet Buccal Smear substudy_v1.0_24.03.2006PatientInformationSheet1.0 Historic 24/03/2006
SAE Report_v1.2_25.01.2005SAEform1.2 Historic 25/01/2005
SAE Report_v1.3_14.09.2006SAEform1.3 Historic 14/09/2006
SAE Report_v1.4_15.04.2007SAEform1.4 Historic 15/04/2007
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