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

Toulouse University Hospital

Status: Completed

Conditions: Lymphoma

Treatments: Other: AMA (Assistance for ambulatory patients)

Study type: Interventional

Funder types: Other

Identifiers

NCT03336138

RC31/12/0072

Details and patient eligibility

About

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.

Enrollment: 350 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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).

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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350 participants in 2 patient groups

AMA group

Active Comparator group

Description:

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

Treatment:

Other: AMA (Assistance for ambulatory patients)

Control group

No Intervention group

Description:

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