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

Primary Purpose

Lymphoma

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
AMA (Assistance for ambulatory patients)
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lymphoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Clinique Claude Bernard
  • Hospital
  • Bayonne Hospital
  • University Hospital Bordeaux
  • Hospital
  • Clinique Marzet
  • Rodez Hospital
  • Tarbes Hospital
  • Clinique Saint Jean
  • University Hospital of Toulouse

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

AMA group

Control group

Arm Description

Patient with telephone follow-up modality called AMA (Assistance for ambulatory patients)

Patient with standard follow-up with no specific assistance for ambulatory patients

Outcomes

Primary Outcome Measures

dose-relative intensity (RDI)
reduction of RDI

Secondary Outcome Measures

Full Information

First Posted
October 30, 2017
Last Updated
April 25, 2019
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT03336138
Brief Title
Application of Telemedicine to the Management of Aggressive Lymphomas
Acronym
AMA
Official Title
Application of Telemedicine to the Management of Aggressive Lymphomas: a Regional Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 2012 (Actual)
Primary Completion Date
January 31, 2019 (Actual)
Study Completion Date
January 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
350 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AMA group
Arm Type
Active Comparator
Arm Description
Patient with telephone follow-up modality called AMA (Assistance for ambulatory patients)
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patient with standard follow-up with no specific assistance for ambulatory patients
Intervention Type
Other
Intervention Name(s)
AMA (Assistance for ambulatory patients)
Intervention Description
telephone follow-up modality
Primary Outcome Measure Information:
Title
dose-relative intensity (RDI)
Description
reduction of RDI
Time Frame
through study completion, an average of 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LAURENT Guy, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique Claude Bernard
City
Albi
ZIP/Postal Code
81000
Country
France
Facility Name
Hospital
City
Auch
ZIP/Postal Code
32000
Country
France
Facility Name
Bayonne Hospital
City
Bayonne
ZIP/Postal Code
64000
Country
France
Facility Name
University Hospital Bordeaux
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Hospital
City
Montauban
ZIP/Postal Code
82000
Country
France
Facility Name
Clinique Marzet
City
Pau
ZIP/Postal Code
64000
Country
France
Facility Name
Rodez Hospital
City
Rodez
ZIP/Postal Code
12000
Country
France
Facility Name
Tarbes Hospital
City
Tarbes
ZIP/Postal Code
65000
Country
France
Facility Name
Clinique Saint Jean
City
Toulouse
ZIP/Postal Code
31000
Country
France
Facility Name
University Hospital of Toulouse
City
Toulouse
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Application of Telemedicine to the Management of Aggressive Lymphomas

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