Randomized trial comparing a web-based follow-up with routine surveillance in high-risk lymphoma: results of the phase 3 Sentinel Lymphoma trial. (Preprint)

Abstract

Relapse is a major event for lymphoma patients. Early detection could have an impact on quality of life and overall survival. Patient-related outcome measures have already demonstrated clinical benefit for lung cancer patients. Evidence is lacking for lymphoma patients. We proposed to evaluate the impact of a web-application follow-up for lymphoma patients at high risk of relapse.

The primary endpoint was to demonstrate a 30% superiority in the detection of significant events in the experimental arm compared with the control arm over a 6-month follow-up.

We planned a prospective, randomized phase 3 trial, comparing web-based follow-up (experimental arm) to a standard arm (control arm). Eligible patients were 18 years of age and older with lymphoma at high risk of relapse. Patients could have T-cell lymphoma in first partial or complete response, Hodgkin lymphoma in second partial or complete response, or diffuse large B-cell lymphoma in first partial or complete response with a revised high IPI score (≥3) or in second partial or complete response. The primary endpoint was to demonstrate a 30% superiority in the detection of significant events in the experimental arm compared with the control arm over a 6-month follow-up. An interim analysis was performed at the inclusion of the first 40 patients.

A total of 52 patients were included between July 12, 2017, and April 7, 2020, at 11 centers in France: 27 in the experimental arm and 25 in the control arm. Median follow-up was 21.3 months (range, [1.3-25.6] months). One hundred and twenty-one events were reported during the study period. Most events were reported in the experimental arm (83/119, 69.7%) compared to 30.2% (36/119) in the control arm, with a mean number of events per patient of 3.5 in the experimental arm and 1.8 in the control arm (p=.0041). Progression and infection were most frequently reported events. Nineteen patients relapsed during follow-up: 6 in the experimental arm and 13 in the standard arm (p<.001), with a median follow-up of 7.7 (range, [2.8-20.6] months) and 6.7 (range [1.9-16.4] months) (p=.94) respectively. Nine out of 26 patients (34.6%) in the experimental group did not receive their electronic questionnaire and the supplier was unable to remedy this. The interim analysis showed that there was no difference in the diagnosis of events.

PRO measures remain essential, but the electronic monitoring method must comply with international safety guidelines.

ClinicalTrials.gov NCT 03154710