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

Follicular Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05899621
• Other study ID #: FL-Gbased
• Status: Recruiting
• Start date: June 1, 2023
• Est. completion date: June 30, 2027

Study information

• Verified date: June 2023
• Source: Ruijin Hospital
• Contact: Weili Zhao, +862164370045
• Phone: +862164370045
• Email: zwl_trial[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 332
• Est. completion date: June 30, 2027
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Follicular Lymphoma
• Lymphoma
• Lymphoma, Follicular

Intervention

Drug:
• Obinutuzumab
Obinutuzumab IV infusion will be administered as per the schedule specified in the respective arm.
• Lenalidomide
Lenalidomide PO will be administered as per the schedule specified in the respective arm.
• Bendamustine
Bendamustine IV infusion will be administered as per the schedule specified in the respective arm.
• Cyclophosphamide
Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.
• Doxorubicin
Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.
• Vincristine
Vincristine IV infusion will be administered as per the schedule specified in the respective arm.
• Prednisone
Prednisone PO will be administered as per the schedule specified in the respective arm.

Locations

Country	Name	City	State
China	Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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]
Secondary	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)
Secondary	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)