Application of Telemedicine to the Management of Aggressive Lymphomas: a Regional Comparative Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 350
- Locations
- 18
- Primary Endpoint
- dose-relative intensity (RDI)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
AMA group
Patient with telephone follow-up modality called AMA (Assistance for ambulatory patients)
Intervention: AMA (Assistance for ambulatory patients) (Other)
Control group
Patient with standard follow-up with no specific assistance for ambulatory patients
Outcomes
Primary Outcomes
dose-relative intensity (RDI)
Time Frame: through study completion, an average of 2 years
reduction of RDI
Secondary Outcomes
No secondary outcomes reported