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

Not yet recruiting

• Conditions: Diffuse Large B Cell Lymphoma (DLBCL)
• Interventions: Drug: Glofitamab; Drug: Obinutuzumab

• Registration Number: NCT06656234
• Lead Sponsor: Ruijin Hospital

Brief Summary

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

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-23
• Study First Submitted QC: 2024-10-23
• Last Update Submitted: 2024-10-23
• Study First Posted: 2024-10-24
• Last Update Posted: 2024-10-24
• Study Start: 2024-10-30
• Primary Completion: 2027-09-15
• Study Completion: 2028-09-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1	Glofitamab	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).
Cohort 1	Obinutuzumab	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).

Primary Outcome Measures

Name	Time	Method
Progression free survival (PFS) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma	Baseline up to end of study (EOS) (approximately 48 months)

Secondary Outcome Measures

Name	Time	Method
Complete Response Rate (CRR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma	Baseline up to EOS (approximately 48 months)
Overall Response Rate (ORR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma	Baseline up to EOS (approximately 48 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 48 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 48 months)
Time to Next Treatment (TTNT)	From the start of glofitamab treatment to the initiation of next-line treatment (up to approximately 48 months)
Overall Survival (OS)	From the start of glofitamab treatment until the date of death from any cause (up to approximately 48 months)

Trial Locations

Locations (1)

Ruijin Hospital, Shanghai JiaoTong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China