Obinutuzumab in Chinese Real-world Patients With iNHL

Sponsor

Affiliated Hospital of Nantong University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05968001

Collaborator

(none)

400

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphomas Non-Hodgkin's B-Cell	Drug: Obinutuzumab

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 Design

Study Type:

Observational

Anticipated Enrollment :

400 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Efficacy and Safety of Obinutuzumab in Chinese Patients With Indolent Non-Hodgkin's B-cell Lymphoma in the Real-World.

Anticipated Study Start Date :

Jul 20, 2023

Anticipated Primary Completion Date :

Dec 30, 2024

Anticipated Study Completion Date :

Jul 20, 2026

Arms and Interventions

Arm	Intervention/Treatment
Cohort 1 the younger cohort (aged ≥ 18 and < 60 years at the start of treatment)	Drug: Obinutuzumab obinutuzumab (G)-contained regimens, including GB, G-CHOP, and G-CVP.
Cohort 2 the older cohort (aged ≥ 60 years at the start of treatment)	Drug: Obinutuzumab obinutuzumab (G)-contained regimens, including GB, G-CHOP, and G-CVP.

Arm

Intervention/Treatment

Cohort 1

the younger cohort (aged ≥ 18 and < 60 years at the start of treatment)

Drug: Obinutuzumab

obinutuzumab (G)-contained regimens, including GB, G-CHOP, and G-CVP.

Cohort 2

the older cohort (aged ≥ 60 years at the start of treatment)

Drug: Obinutuzumab

obinutuzumab (G)-contained regimens, including GB, G-CHOP, and G-CVP.

Outcome Measures

Primary Outcome Measures

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

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

Other Outcome Measures

Exploratory Endpoints [12 months]
Subgroup analyses will be performed for some special populations, such as in high-risk patients

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country
1	Changzhou No.2 People's Hospital	Changzhou	Jiangsu	China
2	The First People's hospital of Changzhou	Changzhou	Jiangsu	China
3	Huai'an First People's hospital	Huai'an	Jiangsu	China
4	Jiangyin People's Hospital	Jiangyin	Jiangsu	China
5	Jingjiang People's Hospital	Jingjiang	Jiangsu	China
6	The first people's hospital of Lianyungang	Lianyungang	Jiangsu	China
7	The second people's hospital of Lianyungang	Lianyungang	Jiangsu	China
8	Jiangsu Province Hospital of Chinese Medicine	Nanjing	Jiangsu	China
9	Jiangsu Province Hospital	Nanjing	Jiangsu	China
10	Nanjing Drum Tower Hospital	Nanjing	Jiangsu	China
11	Nanjing Jiangning Hospital	Nanjing	Jiangsu	China
12	Nantong Tumor Hospital	Nantong	Jiangsu	China
13	Affiliated Hospital of Nantong University	Nanyang	Jiangsu	China
14	The Second Affiliated Hospital of Soochow University	Suzhou	Jiangsu	China
15	Jiangsu Taizhou People's Hospital	Taizhou	Jiangsu	China
16	Affiliated Hospital of Jiangnan University	Wuxi	Jiangsu	China
17	Wuxi People's Hospital	Wuxi	Jiangsu	China
18	Wuxi Second People's Hospital	Wuxi	Jiangsu	China
19	Yancheng No.1 People's Hospital	Yancheng	Jiangsu	China
20	Yancheng Third People's Hospital	Yancheng	Jiangsu	China
21	Subei People's Hospital	Yangzhou	Jiangsu	China
22	Yixing People's Hospital	Yixing	Jiangsu	China
23	Zhangjiagang First People's Hospital	Zhangjiagang	Jiangsu	China
24	Affiliated Hospital of Jiangsu University	Zhenjiang	Jiangsu	China
25	Zhenjiang First People's Hospital	Zhenjiang	Jiangsu	China

Sponsors and Collaborators

Affiliated Hospital of Nantong University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wenyu Shi, Director, Department of Oncology, Affiliated Hospital of Nantong University

ClinicalTrials.gov Identifier:

NCT05968001

Other Study ID Numbers:

JCLG-23-04

First Posted:

Aug 1, 2023

Last Update Posted:

Aug 1, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Lymphoma

Lymphoma, B-Cell

Obinutuzumab

Study Results

No Results Posted as of Aug 1, 2023