Clinical trial · Interventional
Electronic MonitorIng of Events for dIffuse Large b Cell LYmphoma
Evaluation of a Web Application on Event Reporting for Patients With B Lymphoma on First Line Treatment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ONCOLAXY Follow-up | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ONCOLAXY follow-up
- description
- patients will make a regular assessment of symptoms via an electronic questionnaire
- interventionNames
- Device: ONCOLAXY Follow-up
- type
- NO_INTERVENTION
- label
- Standard follow-up
- description
- patients will have the standard follow-up
Primary outcomes (17)
- measure
- Description of events
- timeFrame
- 29 months
- description
- The events will be collected (CTCAE V5.0) per patient
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available