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Obinutuzumab in Chinese Real-world Patients With iNHL

A

Affiliated Hospital of Nantong University

Status

Not yet enrolling

Conditions

Lymphomas Non-Hodgkin's B-Cell

Treatments

Drug: Obinutuzumab

Study type

Observational

Funder types

Other

Identifiers

NCT05968001
JCLG-23-04

Details and patient eligibility

About

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.

Full 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.

Enrollment

400 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

400 participants in 2 patient groups

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

Trial contacts and locations

25

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Central trial contact

Wenyu Shi, PhD

Data sourced from clinicaltrials.gov

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