A Real-world Study of Obinutuzumab-based Therapy for Previously Untreated FL
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Obinutuzumab, Lenalidomide, Bendamustine, Cyclophosphamide.
- Who it may be relevant to
- Registry conditions: Follicular Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Real-world Study of the Efficacy and Safety of Obinutuzumab-based Therapy for Previously Untreated Follicular Lymphoma
Overview
This study aims to observe and explore the efficacy and safety of obinutuzumab-based therapy for previously untreated follicular lymphoma
Detailed description
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.
Interventions
- Drug Obinutuzumab
Obinutuzumab IV infusion will be administered as per the schedule specified in the respective arm. - Drug Lenalidomide
Lenalidomide PO will be administered as per the schedule specified in the respective arm. - Drug Bendamustine
Bendamustine IV infusion will be administered as per the schedule specified in the respective arm. - Drug Cyclophosphamide
Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm. - Drug Doxorubicin
Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm. - Drug Vincristine
Vincristine IV infusion will be administered as per the schedule specified in the respective arm. - Drug Prednisone
Prednisone PO will be administered as per the schedule specified in the respective arm.
Primary outcome measures
- Objective response rate (ORR) [Time frame: End of treatment visit (6 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]]
Secondary outcome measures (3)
- Complete response rate (CR) [Time frame: End of treatment visit (6 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]]
- Progression free survival [Time frame: Baseline up to data cut-off (up to approximately 2 years)]
- Duration of response [Time frame: Baseline up to data cut-off (up to approximately 2 years)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai
Identifiers
NCT: NCT05899621 · FL-Gbased