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

Sponsor

Ruijin Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05899621

Collaborator

(none)

332

Enrollment

Location

Anticipated Duration (Months)

6.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Follicular Lymphoma	Drug: Obinutuzumab Drug: Lenalidomide Drug: Bendamustine Drug: Cyclophosphamide Drug: Doxorubicin Drug: Vincristine Drug: Prednisone

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

332 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Jun 30, 2025

Anticipated Study Completion Date :

Jun 30, 2027

Arms and Interventions

Arm	Intervention/Treatment
GR 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 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.
GB 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 Obinutuzumab IV infusion 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.
GCHOP 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 Obinutuzumab 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.

Arm

Intervention/Treatment

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

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.

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

Obinutuzumab IV infusion 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.

GCHOP

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

Obinutuzumab 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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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