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

N/ANot Yet RecruitingNCT06656234

Ruijin Hospital200 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Diffuse Large B Cell Lymphoma (DLBCL)

Interventions

GlofitamabDRUG

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

ObinutuzumabDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Ruijin Hospital, Shanghai JiaoTong University School of Medicine

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Progression free survival (PFS) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma

Time frame: Baseline up to end of study (EOS) (approximately 48 months)

Secondary Outcomes

Complete Response Rate (CRR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma

Time frame: Baseline up to EOS (approximately 48 months)

Overall Response Rate (ORR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma

Time frame: Baseline up to EOS (approximately 48 months)

Duration of Response (DoR)

Time frame: 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)

Time frame: 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)

Time frame: From the start of glofitamab treatment to the initiation of next-line treatment (up to approximately 48 months)

Overall Survival (OS)

Time frame: From the start of glofitamab treatment until the date of death from any cause (up to approximately 48 months)

Central Contacts

Weili Zhao

CONTACT

008602164370045 zwl_trial@163.com

Data from ClinicalTrials.gov

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