A Real-world Study of Obinutuzumab-based Therapy for Previously Untreated FL

Study Overview
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Brief Summary
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This study aims to observe and explore the efficacy and safety of obinutuzumab-based therapy for previously untreated follicular lymphoma

Detailed Description
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This study aims to observe and explore the efficacy and safety of obinutuzumab-based therapy for previously untreated follicular lymphoma. This study is a non-interventional real world, observational study and all registered data are collected from real clinical practice cases. The medical data includes patient demographic, tumor characteristics, laboratory examination, history of treatments, adverse reactions, efficacy results and possible prognostic factors.

Official Title
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A Real-world Study of the Efficacy and Safety of Obinutuzumab-based Therapy for Previously Untreated Follicular Lymphoma

Conditions
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Follicular Lymphoma

Intervention / Treatment
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* Drug: Obinutuzumab
* Drug: Lenalidomide
* Drug: Bendamustine
* Drug: Cyclophosphamide
* Drug: Doxorubicin
* Drug: Vincristine
* Drug: Prednisone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologically confirmed CD20 positive follicular lymphoma grade 1, 2, or 3A based on 2016 WHO classification Treatment naive Age ≥ 18 years Indications for treatment confirmed Must has measurable lesion in CT or PET-CT prior to treatment Considered suitable for GR, GB or GCHOP regimens Informed consented Exclusion Criteria: Transformed follicular lymphoma or 3B follicular lymphoma; HBsAg positive and / or HBcAb positive with HBV DNA titer; HCV antibody positive with HCV-RNA; or HIV positive Central nervous system or meninges involved Any drug contraindication in the treatment plan Patients judged by other researchers to be unsuitable for inclusion in the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| GR<br>Induction(six 21-day cycles): obinutuzumab (G), 1000mg, IV, D1/8/15 (C1), D1 (C2-6); lenalidomide (R), 25mg, PO, D2-11; Maintenance: obinutuzumab (G), 1000mg, every 3 months for 2 years; lenalidomide (R), 25mg, PO, D1-10, every 28 days for 6 cycles | Drug: Obinutuzumab<br>* Obinutuzumab IV infusion will be administered as per the schedule specified in the respective arm.<br>Drug: Lenalidomide<br>* Lenalidomide PO will be administered as per the schedule specified in the respective arm.<br>|
| GB<br>Induction(six 21-day cycles): obinutuzumab (G) 1000mg, IV, D1/8/15 (C1), D1 (C2-6); bendamustine (B), 90 mg/m2, IV, D1-2; Maintenance: obinutuzumab (G), 1000mg, IV, every 3 months for 2 years | Drug: Obinutuzumab<br>* Obinutuzumab IV infusion will be administered as per the schedule specified in the respective arm.<br>Drug: Bendamustine<br>* Bendamustine IV infusion will be administered as per the schedule specified in the respective arm.<br>|
| GCHOP<br>Induction(six 21-day cycles): obinutuzumab (G), 1000mg, IV, D1/8/15 (C1), D1 (C2-6); prednisone (P), 100 mg, PO, D1-5；cyclophosphamide (C), 750 mg/m2, IV, D1; vincristine (O), 1.4 mg/m2 (maximum 2 mg), IV, D1; doxorubicin (H), 50 mg/m2, IV, D1; Maintenance: obinutuzumab (G), 1000mg, IV, every 3 months for 2 years | Drug: Obinutuzumab<br>* Obinutuzumab IV infusion will be administered as per the schedule specified in the respective arm.<br>Drug: Cyclophosphamide<br>* Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.<br>Drug: Doxorubicin<br>* Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.<br>Drug: Vincristine<br>* Vincristine IV infusion will be administered as per the schedule specified in the respective arm.<br>Drug: Prednisone<br>* Prednisone PO will be administered as per the schedule specified in the respective arm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) | Percentage of participants with overall response was determined on the basis of investigator assessments according to 2014 Lugano criteria | End of treatment visit (6 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete response rate (CR) | Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria. | End of treatment visit (6 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days] | 
| Progression free survival | Progression-free survival was defined as the time from the date of first treatment until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first. | Baseline up to data cut-off (up to approximately 2 years) | 
| Duration of response | Time from first occurrence of documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR. Tumor assessments were performed with PET-CT. | Baseline up to data cut-off (up to approximately 2 years) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obinutuzumab, Lymphoma