N/A
N=299
Untreated FolliculaR Lymphoma Treated With OBinituzumAb in a Non-interventional Study (URBAN)
Follicular Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT04034056 ↗Enrolled (actual)
299
Serious AEs
40.5%
Results posted
May 2025
Primary outcome: Primary: Percentage of Participants With Progression of Disease at Year 2 (POD24) — 8.9 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Obinutuzumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Progression of Disease at Year 2 (POD24) |
8.9 | — |
| SECONDARY Percentage of Participants With Progression-free Survival at Year 2 (PFS2) |
85.6 | — |
| SECONDARY Percentage of Participants With PFS at Year 3 (PFS3) |
76.6 | — |
| SECONDARY Time to Next Treatment (TTNT) |
1118 | — |
| SECONDARY Overall Survival (OS) |
1269 | — |
| SECONDARY Time From First Dose to Loss of Clinical Benefit (TTLCB) |
1127 | — |
| SECONDARY Overall Response Rate (ORR) |
95; 95.6; 93.6; 94.3 | — |
| SECONDARY Percentage of Participants With CR |
35.9; 79.7; 87.7; 90.6 | — |
| SECONDARY Percentage of Participants With CR at 30 Months (CR30) |
91 | — |
| SECONDARY Duration of Response (DOR) |
1010 | — |
| SECONDARY Time to Response (TTR) |
96 | — |
| SECONDARY Percentage of Participants With SD |
2.3; 1.5; 2.3; 1.9 | — |
| SECONDARY Percentage of Participants With FDG-PET Response at End of Induction and End of Maintenance |
95.6; 94.3 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) |
287 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs) |
121 | — |
| SECONDARY Number of Participants With Adverse Events of Special Interests (AESIs) |
9 | — |
| SECONDARY Number of Participants With Infusion-related Reactions (IRRs) |
38 | — |
| SECONDARY Percentage of Participants With PFS2 Stratified by Follicular Lymphoma International Prognostic Index (FLIPI) |
0; 6.3; 37.4; 40.6; 12.6; 3.1 | — |
| SECONDARY Percentage of Participants With PFS2 Stratified by ECOG PS |
55.6; 40.8; 2.8; 0.7; 0; 0 | — |
| SECONDARY Percentage of Participants With PFS2 Stratified by Age |
44.5; 55.5 | — |
| SECONDARY Percentage of Participants With PFS2 Stratified by Chemotherapy Backbone Choice |
47.3; 47.3; 5.5 | — |
| SECONDARY Percentage of Participants With PFS2 Stratified by Hepatitis B Virus (HBV) Infection |
4.3; 95.7 | — |
| SECONDARY Percentage of Participants With PFS2 Stratified by Presence of Autoimmune Disease, Renal and Hepatobilliary Disorders |
7; 9.8; 4.3 | — |
| SECONDARY Percentage of Participants With PFS3 Stratified by FLIPI |
0; 5.3; 39.6; 40.5; 11.5; 3.1 | — |
| SECONDARY Percentage of Participants With PFS3 Stratified by ECOG PS |
57.1; 39.7; 3.2; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With PFS3 Stratified by Age |
46.3; 53.7 | — |
| SECONDARY Percentage of Participants With PFS3 Stratified by Chemotherapy Backbone Choice |
45.4; 48.9; 5.7 | — |
| SECONDARY Percentage of Participants With PFS3 Stratified by HBV Infection |
4.4; 95.6 | — |
| SECONDARY Percentage of Participants With PFS3 Stratified by Presence of Autoimmune Disease, Renal and Hepatobilliary Disorders |
7.4; 8.7; 4.4 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04034056). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.