Untreated FolliculaR Lymphoma Treated With OBinituzumAb in a Non-interventional Study (URBAN)

Roche

Status: Completed

Conditions: Follicular Lymphoma

Treatments: Drug: Obinutuzumab

Study type: Observational

Funder types: Industry

Identifiers

NCT04034056

ML41215

Details and patient eligibility

About

To evaluate the effectiveness and safety of obinutuzumab in clinical routine in 1L FL measured by the % of relapse within 24 months from start of therapy.

Full description

This observational study has been planned to evaluate the effectiveness of obinutuzumab in combination with chemotherapy in previously untreated advanced FL patients, in the real world setting in Italy. The study will allow to collect real-life data in a significant number of Italian patients when compared to participants in pivotal studies of obinutuzumab and thus will allow to verify in routine practice (after physician hands-on) the effectiveness and safety management in 50 reference sites all over the country.

Enrollment: 299 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed Informed consent according to local regulations, after performing at least 2 cycles of induction treatment with Obinutuzumab and chemotherapy, within 1 year from beginning of treatment

Exclusion criteria

• Any contraindications to Obinutuzumab therapy according to local label for specific indication;
• Concomitant participation in an interventional clinical study;
• Participants not receiving treatment for untreated follicular lymphoma with Obinutuzumab according to standard of care and in line with local labeling.

Trial design

299 participants in 1 patient group

Obinutuzumab

Treatment:

Drug: Obinutuzumab