Application of Telemedicine to the Management of Aggressive Lymphomas

Not Applicable

Completed

• Conditions: Lymphoma
• Interventions: Other: AMA (Assistance for ambulatory patients)

• Registration Number: NCT03336138
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2017-10-30
• Study First Submitted QC: 2017-11-07
• Study First Posted: 2017-11-08
• Primary Completion: 2019-01-31
• Study Completion: 2019-01-31
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-25
• Last Update Posted: 2019-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AMA group	AMA (Assistance for ambulatory patients)	Patient with telephone follow-up modality called AMA (Assistance for ambulatory patients)

Primary Outcome Measures

Name	Time	Method
dose-relative intensity (RDI)	through study completion, an average of 2 years	reduction of RDI

Trial Locations

Locations (9)

Hospital; 🇫🇷 Montauban, France

Clinique Claude Bernard; 🇫🇷 Albi, France

Bayonne Hospital; 🇫🇷 Bayonne, France

Rodez Hospital; 🇫🇷 Rodez, France

University Hospital Bordeaux; 🇫🇷 Bordeaux, France

Clinique Saint Jean; 🇫🇷 Toulouse, France

Clinique Marzet; 🇫🇷 Pau, France

Tarbes Hospital; 🇫🇷 Tarbes, France

University Hospital of Toulouse; 🇫🇷 Toulouse, France