Lead Investigator: Catherine Thieblemont, Inserm
Title of Proposal Research: Evaluation of surrogate markers in marginal zone lymphoma
Vivli Data Request: 7445
Funding Source: Doctoral grant given by Inserm-Aviesan (FRFT-DOC21).
Potential Conflicts of Interest: None
Summary of the Proposed Research:
Lymphomas are cancers originated from lymphocytes (subpopulation of white cells and part of our immune system). Lymphomas are generally divided in indolent and aggressive lymphomas. While aggressive lymphomas proliferate quickly, indolent lymphomas display a low proliferation rate. Marginal zone lymphomas (MZL) are a group of indolent lymphomas and represent approximately 5%-15% of all non-Hodgkin lymphomas (NHLs) in the Western world. The incidence of MZL increased +1.0% per year in the US from 2001-2017, with increases reported in other countries during this timeframe.
In MZL research, it requires long and costly trials to show a difference in progression-free survival (PFS, i.e. time from treatment start to progression of disease or death from any cause, whichever occurs first) between two therapeutics (up to 8 years), because only a minority of patients will relapse or die over time. The general promise of a useful surrogate marker (i.e. a shorter marker that replaces a primary outcome of interest, such as PFS) is to shorten trials duration and costs.
We already performed a statistical analysis to evaluate a surrogate marker, based on the IELSG-19 trial, and we want to perform the same analysis based on the GALLIUM trial in order to confirm our preliminary results. If our candidate surrogate marker is confirmed, it would shorten the follow-up time in MZL trials from 8 years to only 2 years. Hence, an increasing number of new drugs could be evaluated in this indolent lymphoma and it would enhance the number of dedicated clinical trials.
Requested Studies:
A Multicenter, Phase III, Open-Label, Randomized Study in Previously Untreated Patients With Advanced Indolent Non-Hodgkin’s Lymphoma Evaluating the Benefit of GA101 (RO5072759) Plus Chemotherapy Compared With Rituximab Plus Chemotherapy Followed by GA101 or Rituximab Maintenance Therapy in Responders
Data Contributor: Roche
Study ID: NCT01332968
Sponsor ID: BO21223