The CTC offices are currently closed for refurbishment. Access to trial TMFs and patient records will be limited during this period. We will still be able to receive post during this time, but there may be a small delay in responding to this. Our fax lines may also be subject to disruption. Where possible, please direct all correspondence via email to trial-specific email addresses. We appreciate your patience and understanding.

Due to COVID-19 and current government guidance, UCL CTC staff continue to work remotely with limited access to the office. Please continue to email the trial specific mailbox with any urgent queries. For paper CRF trials, please continue to copy and scan CRFs to the trial inboxes (remove all patient identifiers except Trial Number and Initials) until further notice.

 
Trial Details
Trial status:
Closed
Recruitment start date:
05/12/2007
Funder:
Leukaemia Research Fund
Sponsor:
UCL
Chief Investigator:
Andrew McMillan
Recruitment target:
N/A
EudraCT number:
2005-003479-19
Contact details:
CTC.Rcodox@ucl.ac.uk
Lay summary:
R-CODOX-M/IVAC (aka RCM)
R-CODOX-M/IVAC: A Phase II Single Arm Study of the use of CODOX-M/IVAC with Rituximab (R-CODOX-M/IVAC) in the treatment of patients with Diffuse Large B-Cell Lymphoma (DLBCL) or Burkitt’s Lymphoma (BL) of International Prognostic Index (IPI) High or High I
Description
Design:
Treatment:
Key inclusion/exclusion criteria:
Duration of recruitment:
Aim

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
Protocol v8.2 8.2 Current
Protocol v4.04 Historic
Protocol v5.05 Historic
Protocol v6.06 Historic
Protocol v7.07 Historic
Protocol v7.17.1 Historic
Trial documents
NameTypeVersionCurrent versRelease dateDownload
Accountability Log TrialsLog2.1 Current
Consent form - v7.0 InformedConsentForm7 Current
CRF completeion guidance notesGuidanceDdocument2.1 Current
CTA Amendment Annex IIAmendmentN/A Current
CTA Amendment Cover LetterAmendmentN/A Current
CTA Amendment REC ApprovalAmendmentN/A Current
CTCAEGuidanceDdocument3 Current
Declaration of HelsinkiOtherN/A Current
EoT RECOtherN/A Current
GP Letter v6.0GPletter6 Current
Guidelines for reporting SAEsGuidanceDdocument4.3 Current
Insurance letterOtherN/A Current
Letter to MHRA OtherN/A Current
Master subject listOther1 Current
MHRA Amendment 4.0 Annex II AmendmentN/A Current
MHRA Amendment 4.0 Approval AmendmentN/A Current
MHRA Amendment 4.0 Cover letter AmendmentN/A Current
MHRA Amendment 5.0 Annex IIAmendmentN/A Current
MHRA Amendment 5.0 Approval AmendmentN/A Current
MHRA Amendment 5.0 cover letter AmendmentN/A Current
MHRA Amendment 6 Annex IIAmendmentN/A Current
MHRA Amendment 6 approval AmendmentN/A Current
MHRA Amendment 6.0 cover letterAmendmentN/A Current
MHRA Amendment 8.0 ApprovalAmendmentN/A Current
MHRA Amendment 8.0 Cover Letter AmendmentN/A Current
MHRA Amendment 8.1 ApprovalAmendmentN/A Current
MHRA Amendment 8.1 USM AmendmentN/A Current
MHRA Amendment 8.2 USM ApprovalAmendmentN/A Current
MHRA Amendment 8.2 USM Cover letterAmendmentN/A Current
MHRA Amendment 9.1 Annex II AmendmentN/A Current
MHRA Amendment 9.1 Approval AmendmentN/A Current
MHRA Amendment 9.1 Cover Letter AmendmentN/A Current
MHRA Amendment 9.2 Annex IIAmendmentN/A Current
MHRA Amendment 9.2 Approval AmendmentN/A Current
MHRA Amendment 9.2 Cover Letter AmendmentN/A Current
MHRA Amendment 9.3 Annex II AmendmentN/A Current
MHRA Amendment 9.3 ApprovalAmendmentN/A Current
MHRA Amendment 9.3 Cover LetterAmendmentN/A Current
MHRA CTA amendment Annex IIAmendmentN/A Current
MHRA CTA amendment Cover LetterAmendmentN/A Current
MHRA CTA Application Form OtherN/A Current
MHRA CTA Approval Letter OtherN/A Current
MHRA EoTOtherN/A Current
Order form (NEULASTA) Other3 Current
Other CRFsCRF2 Current
Patient screening log & instructionsGuidanceDdocumentN/A Current
Pharmacy Notification of Temperature Excursion form Other1 Current
Pharmacy Procedure for Reporting Temperature ExcursionsGuidanceDdocument1 Current
PIS - v7.3 PatientInformationSheet7.3 Current
Pregnancy Monitoring ICF (Partner) InformedConsentForm1.1 Current
Pregnancy Monitoring ICF (patient) InformedConsentForm1 Current
Pregnancy Monitoring Information Sheet (partner)PatientInformationSheet1.1 Current
Pregnancy Monitoring Information Sheet (patient)PatientInformationSheet1 Current
Pregnancy Report CRF3 Current
Principles of ICH GCPGuidanceDdocumentN/A Current
REC Amendmenrt 5.0 Annex II AmendmentN/A Current
REC Amendmenrt 5.0 ApprovalAmendmentN/A Current
REC Amendment 4.0 Annex II AmendmentN/A Current
REC Amendment 4.0 Approval AmendmentN/A Current
REC Amendment 4.0 Cover LetterAmendmentN/A Current
REC Amendment 5.0 Cover LetterAmendmentN/A Current
REC Amendment 7.0 Annex IIAmendmentN/A Current
REC Amendment 7.0 ApprovalAmendmentN/A Current
REC Amendment 7.0 Cover LetterAmendmentN/A Current
REC Amendment 8.0 Annex IIAmendmentN/A Current
REC Amendment 8.0 ApprovalAmendmentN/A Current
REC Amendment 8.0 Cover LetterAmendmentN/A Current
REC Amendment 8.1 PIS Annex IIAmendmentN/A Current
REC Amendment 8.1 PIS Cover LetterAmendmentN/A Current
REC Amendment 8.1 PIS revised LetterAmendmentN/A Current
REC Amendment 8.2 Annex IIAmendmentN/A Current
REC Amendment 8.2 ApprovalAmendmentN/A Current
REC Amendment 8.2 Cover LetterAmendmentN/A Current
REC Amendment 9.1 Annex IIAmendmentN/A Current
REC Amendment 9.1 ApprovalAmendmentN/A Current
REC Amendment 9.1 Cover LetterAmendmentN/A Current
REC Amendment 9.2 Letter 1AmendmentN/A Current
REC Amendment 9.2 Letter 2AmendmentN/A Current
REC Application A&BOtherN/A Current
REC Full ApprovalOtherN/A Current
REC Initial Cover LetterOtherN/A Current
Registration FormCRF3 Current
SAE Reporting FormSAEform4.2 Current
SoDA v3.0Other3 Current
SPC - Cyclophophamide IV (Baxter)OtherN/A Current
SPC - Cytarabine Injection Solution 20mg/ml and 100mg/ml (Pharmacia)OtherN/A Current
SPC - Doxorubicin Solution for Injection (Pfizer)OtherN/A Current
SPC - Eposin (etoposide)OtherN/A Current
SPC - Ifosfamide Injection (Baxter)OtherN/A Current
SPC - Mabthera 100mg and 500mgOtherN/A Current
SPC - Methotrexate 25mg/ml solution for Injection (hameln)OtherN/A Current
SPC - NEULASTAOtherN/A Current
SPC - VINCRISTINE (Vincristine Sulphate 1mg/ml 5mg/5ml injection) Hospira (EMC)OtherN/A Current
Sponsorship confirmation letterOther13.10.2005 Current 13/10/2005
Treatment formsCRF2 Current
UCL CTC contact listOtherN/A Current
Withdrawal FormCRF2.2 Current
Addendum to PIS v7.1PatientInformationSheet7.1 Historic
Consent form V4.0 InformedConsentForm4 Historic
Consent form V5.0Other5 Historic
Consent form V6.0InformedConsentForm6 Historic
GP Letter V4.0GPletter4 Historic
GP Letter V5.0GPletter5 Historic
PIS - V5.0 PatientInformationSheet5 Historic
PIS - v7.1PatientInformationSheet7.1 Historic
PIS - v7.2PatientInformationSheet7.2 Historic
PIS V4.0PatientInformationSheet4 Historic
PIS V6.0 PatientInformationSheet6 Historic
SoDA v1.0Other1 Historic
SoDA v2.0Other2 Historic
SoDA v2.1Other2.1 Historic
Contact Us
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Email:
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Telephone:
+44 (0)20 7679 9898 (General CTC Enquiries)
Fax:
020 7679 9899
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