Obinutuzumab in Chinese Real-world Patients With iNHL

Not yet recruiting

• Conditions: Lymphomas Non-Hodgkin's B-Cell
• Interventions: Drug: Obinutuzumab

• Registration Number: NCT05968001
• Lead Sponsor: Affiliated Hospital of Nantong University

Brief Summary

This study aims to assess the clinical efficacy and safety of obinutuzumab in Chinese patients with indolent non-Hodgkin B-cell Lymphoma (predominantly Follicular lymphoma and Marginal zone lymphoma) in a real-world setting.

Detailed Description

This study was a prospective, multicenter, non-interventional, real-world study. The study will be divided into two cohorts: Cohort 1 is the younger cohort (aged ≥ 18 and \< 60 years at the start of treatment); Cohort 2 is the older cohort (aged ≥ 60 years at the start of treatment). Patients in this study will receive obinutuzumab-contained regimens according to the investigators' clinical opinion.

Study Timeline

• Status Verified: 2023-07
• Study Start: 2023-07-20
• Study First Submitted: 2023-07-23
• Study First Submitted QC: 2023-07-23
• Last Update Submitted: 2023-07-23
• Study First Posted: 2023-08-01
• Last Update Posted: 2023-08-01
• Primary Completion: 2024-12-30
• Study Completion: 2026-07-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Age: Age ≥ 18 years at the start of treatment;
• Be diagnosed with grade 1-3a follicular Lymphoma, Marginal zone lymphoma;
• Previously untreated or relapsed or refractory patients;
• Patients who started treatment with otuzumab between June 2021 and April 2023.

Exclusion Criteria

• Patients currently participating or planning to participate in any interventional clinical trial;
• Patients who, in the opinion of the investigator, are Discomfort for any other reason to participate in this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 2	Obinutuzumab	the older cohort (aged ≥ 60 years at the start of treatment)
Cohort 1	Obinutuzumab	the younger cohort (aged ≥ 18 and \< 60 years at the start of treatment)

Primary Outcome Measures

Name	Time	Method
Efficacy Endpoints	12 months	The best objective response rate (ORR), and CR rate; ORR and CR rate at the end of treatment; DCR, DoR, TTNT, PFS, DFS, and OS.

Secondary Outcome Measures

Name	Time	Method
Safety Endpoints	12 months	All AEs, SAEs, Grade 3 AEs, and all other safety variables, including vital signs, Physical examination results, and laboratory parameters.

Trial Locations

Locations (25)

Changzhou No.2 People's Hospital; 🇨🇳 Changzhou, Jiangsu, China

The First People's hospital of Changzhou; 🇨🇳 Changzhou, Jiangsu, China

Huai'an First People's hospital; 🇨🇳 Huai'an, Jiangsu, China

Jiangyin People's Hospital; 🇨🇳 Jiangyin, Jiangsu, China

Jingjiang People's Hospital; 🇨🇳 Jingjiang, Jiangsu, China

The first people's hospital of Lianyungang; 🇨🇳 Lianyungang, Jiangsu, China

The second people's hospital of Lianyungang; 🇨🇳 Lianyungang, Jiangsu, China

Jiangsu Province Hospital of Chinese Medicine; 🇨🇳 Nanjing, Jiangsu, China

Jiangsu Province Hospital; 🇨🇳 Nanjing, Jiangsu, China

Nanjing Drum Tower Hospital; 🇨🇳 Nanjing, Jiangsu, China

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