Status:
COMPLETED
Untreated FolliculaR Lymphoma Treated With OBinituzumAb in a Non-interventional Study (URBAN)
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Follicular Lymphoma
Eligibility:
All Genders
18+ years
Brief Summary
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.
Detailed 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 Ital...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 2 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 22 2024
Estimated Enrollment :
299 Patients enrolled
Trial Details
Trial ID
NCT04034056
Start Date
September 2 2019
End Date
April 22 2024
Last Update
May 9 2025
Active Locations (46)
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1
Ospedale Civile Dello Spirito Santo
Pescara, Abruzzo, Italy, 65100
2
AOU Policlinico Consorziale
Bari, Apulia, Italy, 70124
3
Giovanni Paolo II/I.R.C.C.S. Istituto Tumori
Bari, Apulia, Italy, 70124
4
Asl Bat Ospedale Mons. Dimiccoli
Barletta, Apulia, Italy, 75121