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:
In follow-up (non-recruiting)
Recruitment start date:
18/01/2013
Funder:
Cancer Research UK
Sponsor:
UCL
Chief Investigator:
Rebecca Auer
Recruitment target:
56
EudraCT number:
2011-005156-34
Contact details:
ctc.r2w@ucl.ac.uk
Lay summary:
R2W
Randomised phase 2 trial in WM - Subcutaneous Bortezomib, Clycophosphamide and Rituximab (BCR versus Fludarabine, Cyclophosphamide and Rituximab (FCR) for initial therapy of Waldenstr?m’s macroglobulinaemia (WM): a randomised phase II trial
Description
Design: R2W is a randomised (2:1), non-comparative, multicentre, phase II trial  of bortezomib, cyclophosphamide and rituximab (BCR – experimental) versus fludarabine, cyclophosphamide and rituximab (FCR – control) for initial therapy in patients with symptomatic untreated Waldenstrom’s macroglobulinaemia (WM); using a three-outcome design for the experimental arm.
Treatment: Patients are treated with BCR or FCR (in accordance with the arm to which they are randomised) for 3 cycles when response to treatment is assessed. Those with evidence of progression stop trial treatment. All other patients continue with further 3 cycles (to a total of 6) unless a clear clinical contraindication to further treatment exists.
Key inclusion/exclusion criteria:

Inclusion
  • Age ≥18 years 
  • Performance status 0-2
  • Life expectancy >6 months
  • Confirmed diagnosis of WM with measurable IgM paraprotein
  • Previously untreated disease at any stage requiring therapy at the discretion of the treating physician
  • No previous chemotherapy 

Exclusion
  • Lymphoplasmacytic lymphoma with no detectable serum IgM paraprotein
  • Severe pre-existing neuropathy (> grade 2) 
  • Autoimmune cytopenias
  • Evidence of active Hepatitis B or C infection, or HIV
  • Pregnant or lactating women
  • Life expectancy severely limited by other illness
  • Inadequate renal and liver function
  • History of allergic reaction to compounds containing boron or mannitol
  • Known hypersensitivity to murine compounds
  • Diagnosed or treated for a malignancy other than WM within 5 years (with exceptions)
  • Active systemic infection requiring treatment
  • Concurrent treatment with another investigational agent
  • Severe or life-threatening cardiac, pulmonary, neurological, psychiatric or metabolic disease

Duration of recruitment: 3 years
Aim
The primary objective of the study is to make a preliminary examination of the efficacy and safety of the proposed Bortezomib, Cyclophosphamide and Rituximab regimen for previously untreated patients with Waldenstrom’s macroglobulinaemia and to determine whether this regimen warrants further investigation in the randomised phase III setting. 
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

View map
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

Copyright © 2021 UCL | Disclaimer | Freedom of Information | Accessibility | Privacy | Cookies | Contact Us