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ClinicalTrials.gov ID

NCT05298293

Lead Sponsor

WepromOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

160Estimated

Last Update Posted

Apr 5, 2022Actual

Start Date

Jul 1, 2022Estimated

Primary Completion Date

Dec 1, 2026Estimated

Completion Date

Dec 1, 2026Estimated

Official Title

Evaluation of a Web Application on Event Reporting for Patients With B Lymphoma on First Line Treatment

Brief Summary

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.

• Diffuse Large B Cell Lymphoma

• ONCOLAXY Follow-up

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Prevention

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

WepromOTHER

Collaborators

ResilienceINDUSTRY

Incyte CorporationINDUSTRY

dr.ledu@groupeconfluent.fr

e.lestang@ch-saintnazaire.fr

fmaloisel@solcrr.org