Follicular Lymphoma
Conditions
Keywords
obinutuzumab, Lymphoma
Brief summary
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
DRUGObinutuzumab
Obinutuzumab IV infusion will be administered as per the schedule specified in the respective arm.
DRUGLenalidomide
Lenalidomide PO will be administered as per the schedule specified in the respective arm.
DRUGBendamustine
Bendamustine IV infusion will be administered as per the schedule specified in the respective arm.
DRUGCyclophosphamide
Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.
DRUGDoxorubicin
Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.
DRUGVincristine
Vincristine IV infusion will be administered as per the schedule specified in the respective arm.
DRUGPrednisone
Prednisone PO will be administered as per the schedule specified in the respective arm.
Sponsors
Ruijin Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | End of treatment visit (6 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days] | Percentage of participants with overall response was determined on the basis of investigator assessments according to 2014 Lugano criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete response rate (CR) | End of treatment visit (6 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days] | Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria. |
| Progression free survival | Baseline up to data cut-off (up to approximately 2 years) | 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. |
| Duration of response | Baseline up to data cut-off (up to approximately 2 years) | 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. |
Countries
China
Contacts
Primary ContactWeili Zhao, +862164370045
Backup ContactPengpeng Xu, PhD，MD
Outcome results
None listed