Application of Telemedicine to the Management of Aggressive Lymphomas (AMA)

December 5, 2025 updated by: University Hospital, Toulouse

Application of Telemedicine to the Management of Aggressive Lymphomas: a Regional Comparative Study

The purpose of this study is to evaluate the value of AMA in a comparative multicenter regional study as a reference for aggressive lymphoma. The primary endpoint will be RDI. This study consider that the AMA support should allow a significant improvement of the RDI compared to the control group and thus impact the duration without progression. The study covers 350 patients recruited from 10 regional centers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Albi, France, 81000
        • Clinique Claude Bernard
      • Auch, France, 32000
        • Hospital
      • Bayonne, France, 64000
        • Bayonne Hospital
      • Bordeaux, France, 33000
        • University Hospital Bordeaux
      • Montauban, France, 82000
        • Hospital
      • Pau, France, 64000
        • Clinique Marzet
      • Rodez, France, 12000
        • Rodez Hospital
      • Tarbes, France, 65000
        • Tarbes Hospital
      • Toulouse, France, 31000
        • Clinique Saint Jean
    • France
      • Toulouse, France, France
        • University Hospital of Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient with a recent diffuse large B cell lymphoma (LBDGC), histologically proven, with treatment not started
  • a priori likely to be treated by rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone every 21 days (R-CHOP21) for 8 cycles or rituximab, doxorubicin, cyclophosphamide, vindesine, bleomycin, and prednisone (R-ACVBP).
  • Index international prognosis (IPI) measurable (IPI-aa), adjusted for age. Any IPI-aa is eligible.
  • accepting the study

Exclusion Criteria:

  • Patient with another type of lymphoma (including transformed follicular forms)
  • Patient having already started his treatment.
  • Life expectancy <3 months.
  • Carcinologic history
  • Serum positive for HIV or hepatitis B virus (HBV).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: AMA group
Patient with telephone follow-up modality called AMA (Assistance for ambulatory patients)
Other: AMA (Assistance for ambulatory patients)
telephone follow-up modality
No Intervention: Control group
Patient with standard follow-up with no specific assistance for ambulatory patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
dose-relative intensity (RDI)
Time Frame: through study completion, an average of 2 years
reduction of RDI
through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: LAURENT Guy, MD, University Hospital, Toulouse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2012

Primary Completion (Actual)

January 31, 2019

Study Completion (Actual)

January 31, 2019

Study Registration Dates

First Submitted

October 30, 2017

First Submitted That Met QC Criteria

November 7, 2017

First Posted (Actual)

November 8, 2017

Study Record Updates

Last Update Posted (Estimated)

December 15, 2025

Last Update Submitted That Met QC Criteria

December 5, 2025

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/12/0072

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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