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

This study is currently recruiting participants.
Verified November 2017 by University Hospital, Toulouse
Sponsor:
ClinicalTrials.gov Identifier:
NCT03336138
First Posted: November 8, 2017
Last Update Posted: November 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Toulouse
  Purpose
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.

Condition Intervention
Lymphoma Other: AMA (Assistance for ambulatory patients)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Application of Telemedicine to the Management of Aggressive Lymphomas: a Regional Comparative Study

Resource links provided by NLM:


Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • dose-relative intensity (RDI) [ Time Frame: through study completion, an average of 2 years ]
    reduction of RDI


Estimated Enrollment: 350
Actual Study Start Date: January 2012
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03336138


Contacts
Contact: LAURENT Guy, MD laurent.g@chu-toulouse.fr
Contact: COMPACI Gisèle, Nurse compaci.g@chu-toulouse.fr

Locations
France
Clinique Claude Bernard Recruiting
Albi, France, 81000
Contact: Houyau Philippe, MD         
Hospital Recruiting
Auch, France, 32000
Contact: Vaillant Willy, MD         
Bayonne Hospital Recruiting
Bayonne, France, 64000
Contact: Banos Anne, MD         
University Hospital Bordeaux Recruiting
Bordeaux, France, 33000
Contact: Fitoussi Olivier, MD         
Hospital Recruiting
Montauban, France, 82000
Contact: Carrero Miguel, MD         
Clinique Marzet Recruiting
Pau, France, 64000
Contact: Schlaifer Daniel, MD         
Rodez Hospital Recruiting
Rodez, France, 12000
Contact: Mosser Laurent, MD         
Tarbes Hospital Recruiting
Tarbes, France, 65000
Contact: Dingremont Claire, MD         
Clinique Saint Jean Recruiting
Toulouse, France, 31000
Contact: Suc Etienne, MD         
University Hospital of Toulouse Recruiting
Toulouse, France
Contact: LAURENT Guy, MD         
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: LAURENT Guy, MD University Hospital, Toulouse
  More Information

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03336138     History of Changes
Other Study ID Numbers: RC31/12/0072
First Submitted: October 30, 2017
First Posted: November 8, 2017
Last Update Posted: November 9, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases