Electronic MonitorIng of Events for dIffuse Large b Cell LYmphoma (EMILY)

Weprom

Status: Not yet enrolling

Conditions: Diffuse Large B Cell Lymphoma

Treatments: Device: ONCOLAXY Follow-up

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05298293

WP-2022-01

2021-A02957-34 (Other Identifier)

Details and patient eligibility

About

Diffuse large B cell lymphoma is the most common malignant lymphoid hemopathy. More than half of the patients will be cured with an RCHOP-type immunochemotherapy protocol (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone). Monitoring of adverse effects, risk of relapse and quality of life are essential in overall management. Patients are the best candidates to report them. Managing these events should improve quality of life and reduce costs. The aim of this study is to assess the feasibility of monitoring these events by a web application (Oncolaxy©) and to compare it with a control population in the context of a randomized pilot study including 80 patients per arm with diffuse large cell B lymphoma in first-line treatment with R-CHOP.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient with untreated large B cell lymphoma requiring a first line treatment by RCHOP or R-mini-CHOP
2. Patient aged 18 years or older at the time of signing Informed Consent Form
3. Additional Intrathecal or/and intravenous treatment with Methotrexate allowed, if indicated
4. Eastern Cooperative Oncology Group (ECOG) Performance Status < 3
5. Patient with internet access (or has someone at home who can help send patients' symptoms or complete the form)
6. Patient enrolled in social security
7. Patient has given his written consent ahead of any specific protocol procedure

Exclusion criteria

1. Patient with symptomatic brain metastases,
2. Patient deprived of their liberty, under guardianship or trusteeship
3. Patient is being treated for another cancer and has not been cured
4. Patient with dementia, mental disorders or psychological pathology which could compromise patient informed consent and/or the observance of the study protocol
5. Patient cannot submit to the protocol for psychological, social, familial or geographical reasons
6. Patient is pregnant or breastfeeding

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

ONCOLAXY follow-up

Experimental group

Description:

patients will make a regular assessment of symptoms via an electronic questionnaire

Treatment:

Device: ONCOLAXY Follow-up

Standard follow-up

No Intervention group

Description:

patients will have the standard follow-up