The Effectiveness and Safety of Glofitamab in Real-World Clinical Practice Among Chinese Adult Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma: A Prospective, Observational, Multicenter Study

NCT ID: NCT06656234

Last Updated: 2024-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-30

Study Completion Date

2028-09-15

Brief Summary

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The purpose of this study is to evaluate the the efficacy and safety in the real-world settings of glofitamab among Chinese R/R DLBCL participants.

Detailed Description

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Conditions

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Diffuse Large B Cell Lymphoma (DLBCL)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 1

Participants with relapsed or refractory (R/R) DLBCL who have started receiving glofitamab at physician's discretion in accordance with local clinical practice and/or labeling will be observed for safety and efficacy until death, withdrawal of consent, loss to follow-up or end of study whichever occurs first (up to approximately 4 years).

Glofitamab

Intervention Type DRUG

Glofitamab will be administered at the discretion of the physician per local clinical practice and local labeling.

Obinutuzumab

Intervention Type DRUG

Obinutuzumab pre-treatment is given intravenously at a dose of 1g on Cycle 1 Day 1.

Interventions

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Glofitamab

Glofitamab will be administered at the discretion of the physician per local clinical practice and local labeling.

Intervention Type DRUG

Obinutuzumab

Obinutuzumab pre-treatment is given intravenously at a dose of 1g on Cycle 1 Day 1.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Be diagnosed as R/R DLBCL
* Participants who will be treated with glofitamab (known as being recommended and having the intention to be treated with glofitamab at the time of signing informed consent) or have initiated glofitamab treatment within 6 months prior to enrollment and after the indication approval will be observed in this study.

Exclusion Criteria

* Any other reason that, in the investigator's opinion, makes the participant unsuitable to participate in this study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ruijin Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhao Weili

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ruijin Hospital, Shanghai JiaoTong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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Weili Zhao

Role: CONTACT

008602164370045

Facility Contacts

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Weili Zhao

Role: primary

008602164370045

Other Identifiers

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GloReal

Identifier Type: -

Identifier Source: org_study_id

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