A Study of Efficacy and Safety of Glofitamab in Combination With Salvage Therapy in a Real-world Setting in Chinese Adult Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma.

Recruiting

• Conditions: B-cell Non-Hodgkin Lymphoma
• Interventions: Drug: Glofitamab

• Registration Number: NCT06497452
• Lead Sponsor: The First Affiliated Hospital of Soochow University

Brief Summary

The purpose of this study is to assess the efficacy and safety in the real-world settings of glofitamab in combination with salvage therapy among Chinese adult patients with relapsed or refractory B-cell non-hodgkin lymphoma.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-06
• Study Start: 2024-06-01
• Study First Submitted: 2024-07-05
• Study First Submitted QC: 2024-07-05
• Last Update Submitted: 2024-07-05
• Study First Posted: 2024-07-11
• Last Update Posted: 2024-07-11
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Be diagnosed as B-NHL
• Relapse or refractory to previous treatment
• Participants who will be treated with glofitamab

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Exclusion Criteria

• Participant who currently participates in or with plan to participate in any interventional clinical trial
• Any other reason that, in the investigator's opinion, makes the participant unsuitable to participate in this study.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational Cohort	Glofitamab	-

Primary Outcome Measures

Name	Time	Method
Best Complete Response Rate (bCRR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma	Baseline up to EOT (approximately 9 months)

Secondary Outcome Measures

Name	Time	Method
Best Overall Response Rate (bORR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma	Baseline up to EOT (approximately 9 months)
Duration of Response (DoR)	From the date of the first occurrence of a documented CR or partial response (PR) to the date of progression, relapse, or death from any cause, whichever occurs first (up to approximately 24 months)
Event Free Survival (EFS) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma	From the start of glofitamab treatment to any treatment failure including disease progression, relapse, initiation of new antilymphoma therapy (NALT), or death from any cause, which occurs first (up to approximately 24 months)
Duration of Complete Response (DoCR)	From the date of the first occurrence of a documented CR to the date of progression, relapse, or death from any cause, whichever occurs first (up to approximately 24 months)
PFS Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma	Baseline up to end of study (approximately 24 months)
Overall Survival (OS)	From the start of glofitamab treatment until the date of death from any cause (up to approximately 24 months)
Time to Next Treatment (TTNT)	From the start of glofitamab treatment to the initiation of next-line treatment (up to approximately 24 months)

Trial Locations

Locations (1)

The First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China