Clinical trial NCT06656234: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Diffuse Large B Cell Lymphoma (DLBCL)
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2024-10-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Progression free survival (PFS) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma
timeFrame: Baseline up to end of study (EOS) (approximately 48 months)
Secondary outcomes:
measure: Complete Response Rate (CRR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma
timeFrame: Baseline up to EOS (approximately 48 months)
measure: Overall Response Rate (ORR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma
timeFrame: Baseline up to EOS (approximately 48 months)
measure: Duration of Response (DoR)
timeFrame: 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)
measure: Duration of Complete Response (DoCR)
timeFrame: 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)
measure: Time to Next Treatment (TTNT)
timeFrame: From the start of glofitamab treatment to the initiation of next-line treatment (up to approximately 48 months)
measure: Overall Survival (OS)
timeFrame: From the start of glofitamab treatment until the date of death from any cause (up to approximately 48 months)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai JiaoTong University School of Medicine
state: Shanghai
Study officials:
References: