Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR) in High-risk Treatment-naive Patients with Follicular Lymphoma (FL)

Phase 2

Not yet recruiting

• Conditions: Follicular Lymphoma
• Interventions: Drug: Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR)

• Registration Number: NCT06549335
• Lead Sponsor: Ruijin Hospital

Brief Summary

This is a prospective, multiple-centers, open-label, single-arm clinical study designed to evaluate the efficacy and safety of Zanubrutinib, Obinutuzumab, and Lenalidomide (ZGR) in high-risk treatment-naive patients with follicular lymphomas

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-08
• Study First Submitted QC: 2024-08-08
• Study First Posted: 2024-08-12
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-11
• Study Start: 2024-12-01
• Primary Completion: 2026-12-01
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

1. Pathologically confirmed CD20 positive follicular lymphoma grade 1, 2, or 3A based on 2016 WHO classification
2. Treatment naive
3. Age ≥ 18 years
4. Indications for treatment confirmed
5. Identified as high-risk group by Follicular Lymphoma International Prognostic Index 2 (FLIPI2) at enrollment
6. Must has measurable lesion in CT or PET-CT prior to treatment
7. Considered suitable for ZGR regimens
8. 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
• Any drug contraindication in the treatment plan
• Pregnant or lactating women
• Patients judged by other researchers to be unsuitable for inclusion in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental: Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR)	Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR)	-

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	At the end of Cycle 6 (each cycle is 28 days)	Percentage of participants with overall response was determined on the basis of investigator assessments according to 2014 Lugano criteria

Secondary Outcome Measures

Name	Time	Method
Complete response rate (CR)	At the end of Cycle 6 (each cycle is 28 days)	Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
Partial response rate (PR)	At the end of Cycle 6 (each cycle is 28 days)	Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
2-year progression free survival rate	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.
2-year overall survival rate	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 death from any cause.

Trial Locations

Locations (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, China