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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03336138
Recruitment Status : Completed
First Posted : November 8, 2017
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief Summary:
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 or disease Intervention/treatment Phase
Lymphoma Other: AMA (Assistance for ambulatory patients) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 350 participants
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
Actual Study Start Date : January 2012
Actual Primary Completion Date : January 31, 2019
Actual Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma Telehealth

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



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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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).

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


Locations
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France
Clinique Claude Bernard
Albi, France, 81000
Hospital
Auch, France, 32000
Bayonne Hospital
Bayonne, France, 64000
University Hospital Bordeaux
Bordeaux, France, 33000
Hospital
Montauban, France, 82000
Clinique Marzet
Pau, France, 64000
Rodez Hospital
Rodez, France, 12000
Tarbes Hospital
Tarbes, France, 65000
Clinique Saint Jean
Toulouse, France, 31000
University Hospital of Toulouse
Toulouse, France
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: LAURENT Guy, MD University Hospital, Toulouse
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03336138    
Other Study ID Numbers: RC31/12/0072
First Posted: November 8, 2017    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases