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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 299
- Locations
- 46
- Primary Endpoint
- Percentage of Participants With Progression of Disease at Year 2 (POD24)
Study Overview
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 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Obinutuzumab
Intervention: Obinutuzumab (Drug)
Outcomes
Primary Outcomes
Percentage of Participants With Progression of Disease at Year 2 (POD24)
Time Frame: At Year 2
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
- Percentage of Participants With Progression-free Survival at Year 2 (PFS2)(At Year 2)
- Percentage of Participants With PFS at Year 3 (PFS3)(At Year 3)
- Time to Next Treatment (TTNT)(Up to approximately 56 months)
- Overall Survival (OS)(Up to approximately 56 months)
- Time From First Dose to Loss of Clinical Benefit (TTLCB)(Up to approximately 56 months)
- Overall Response Rate (ORR)(Up to approximately 56 months)
- Percentage of Participants With CR(Up to approximately 56 months)
- Percentage of Participants With CR at 30 Months (CR30)(At 30 months)
- Duration of Response (DOR)(Up to approximately 56 months)
- Time to Response (TTR)(Up to approximately 56 months)
- Percentage of Participants With SD(Up to approximately 56 months)
- Percentage of Participants With FDG-PET Response at End of Induction and End of Maintenance(Up to approximately 56 months)
- Number of Participants With Adverse Events (AEs)(Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy (approximately 48 months))
- Number of Participants With Serious Adverse Events (SAEs)(Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy (approximately 48 months))
- Number of Participants With Adverse Events of Special Interests (AESIs)(Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy (approximately 48 months))
- Number of Participants With Infusion-related Reactions (IRRs)(Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy (approximately 48 months))
- Percentage of Participants With PFS2 Stratified by Follicular Lymphoma International Prognostic Index (FLIPI)(At Year 2)
- Percentage of Participants With PFS2 Stratified by ECOG PS(At Year 2)
- Percentage of Participants With PFS2 Stratified by Age(At Year 2)
- Percentage of Participants With PFS2 Stratified by Chemotherapy Backbone Choice(At Year 2)
- Percentage of Participants With PFS2 Stratified by Hepatitis B Virus (HBV) Infection(At Year 2)
- Percentage of Participants With PFS2 Stratified by Presence of Autoimmune Disease, Renal and Hepatobilliary Disorders(At Year 2)
- Percentage of Participants With PFS3 Stratified by FLIPI(At Year 3)
- Percentage of Participants With PFS3 Stratified by ECOG PS(At Year 3)
- Percentage of Participants With PFS3 Stratified by Age(At Year 3)
- Percentage of Participants With PFS3 Stratified by Chemotherapy Backbone Choice(At Year 3)
- Percentage of Participants With PFS3 Stratified by HBV Infection(At Year 3)
- Percentage of Participants With PFS3 Stratified by Presence of Autoimmune Disease, Renal and Hepatobilliary Disorders(At Year 3)