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The University of Southampton
Southampton Clinical Trials Unit

REMoDL-B Trial

Title

REMoDL-B: A Randomised Evaluation of Molecular guided therapy for Diffuse Large B-cell Lymphoma with Bortezomib 

Description

REMoDL-B is a multi-centre, open label randomised trial comparing the standard care treatment of R-CHOP with R-CHOP plus bortezomib (RB-CHOP). All patients will receive one cycle of R-CHOP. They will then be randomised to receive either R-CHOP or RB-CHOP on the basis of the molecular profile of their lymphoma and the IPI score. 

Objectives

Primary Objectives:

  • To demonstrate superior clinical efficacy, as measured by Progression-free survival (PFS), of bortezomib in combination with rituximab and CHOP (RB-CHOP) versus  R-CHOP alone for the treatment of previously untreated patients with DLBCL.
  • To assess whether the molecular phenotype, either activated B-cell (ABC) like or germinal centre B-cell (GCB) like, of DLBCL determines the benefit from the addition of bortezomib.

Secondary Objectives:

  • To compare overall survival (OS) between both treatment and molecular groups
  • To compare event free survival (EFS) between both treatment and molecular groups
  • To compare disease free survival (DFS) between both treatment and molecular groups
  • To compare time to progression (TTP) between both treatment and molecular groups
  • To compare response duration (RD) between both treatment and molecular groups
  • To compare overall response rate (ORR) and complete response rate (CR) between both treatment groups
  • To assess differences in toxicity between assigned treatments
  • To assess quality of life and chemotherapy induced peripheral neuropathy reported by patients across the two different induction treatments
  • To demonstrate that accurate molecular profiling may be conducted in real-time and relate this to immunohistochemical algorithms.
  • To perform exploratory analysis comparing aberrations in the NF-кB pathway to clinical outcomes by treatment groups

Trial Design

Stratified open-label multicentre randomised Phase III. A novel adaptive trial design will be employed with 2 interim analysis to explore safety and efficacy in the GCB arm patients treated with RB- CHOP. Modified to randomised Phase II in ABC patients only if GCB arm closed.

Trial Status

Closed to reruitment - Currently in follow-up

Population

1132 patients with Diffuse Large B Cell Lymphoma from >50 sites throughout the UK and Switzerland. 

Trial Team:

Senior Trial Manager:

Josh Caddy (023 8120 5537)

Trial Manager:

Marina Lee  (023 8120 5539)

Clinical Data Coordinator:

Zoë Konn (023 8120 5677)

Contact information

Email: remb@soton.ac.uk

Fax: 0844 7740 621

SAE Reporting: CTU@soton.ac.uk 

 

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