Clinical trial · Observational
Untreated FolliculaR Lymphoma Treated With OBinituzumAb in a Non-interventional Study (URBAN)
A Non-Interventional, Retrospective And Prospective, Multicenter, Single Arm Study Evaluating The Effectiveness And Safety Of Obinutuzumab In Patients With Previously Untreated Advanced Follicular Lymphoma
NCT04034056CI-TRIAL-00089493URBANcompletedResults postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
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.
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 |
|---|---|---|---|
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Obinutuzumab | Drug | Obinutuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Obinutuzumab
- interventionNames
- Drug: Obinutuzumab
Primary outcomes (1)
- measure
- Percentage of Participants With Progression of Disease at Year 2 (POD24)
- timeFrame
- At Year 2
- description
- POD24=time from date of treatment initiation with obinutuzumab until first documented PD/death due to PD, whichever occurs first, within 24 months from start of treatment with obinutuzumab. According to standard Cheson criteria \& Deauville 5-point scale, PD=20% increase in sum of longest diameters (LD) of target lesions; for small lymph nodes measuring \<15 millimeters (mm) post therapy, a minimum absolute increase of 5 mm \& LD should exceed 15 mm; appearance of a new lesion; any bone marrow involvement \& any 18F-fluorodeoxyglucose-positron emission tomography (FDG-PET) results. Participants with no PD \& who didn't die due to PD/were lost to follow-up at time of analysis were censored at date of last tumor assessment where no progression was documented/last date of follow-up for disease, whichever was last. Participants without post-baseline tumor assessments were censored at time of their baseline visit unless death due to PD occurred prior to their first scheduled tumor assessment.
Secondary outcomes (28)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDPinto A, Caltagirone M, Battista M, Gazzoli GC, Patti C, Pennese E, De Lorenzo S, Pavone V, Merli M, Chiarenza A, Gorgone AG, Piazza F, Puccini B, Noto A, Arcaini L, De Filippi R, Zinzani PL, Ferreri AJM, Ladetto M, Ferrari S, Gritti G. Exposure to obinutuzumab does not affect outcomes of SARS-CoV-2 infection in vaccinated patients with newly diagnosed advanced-stage follicular lymphoma. Br J Haematol. 2024 Dec;205(6):2219-2227. doi: 10.1111/bjh.19661. Epub 2024 Jul 22. PMID 39039666