Real-World Study of DLBCL With Different Genetic Subtypes

Recruiting

• Conditions: DLBCL - Diffuse Large B Cell Lymphoma; Lymphoma
• Interventions: Other: Other

• Registration Number: NCT06026488
• Lead Sponsor: Ruijin Hospital

Brief Summary

To collect and evaluate the data of real-world treatment regimen, efficacy, safety and survival information of DLBCL patients with different genetic suptypes

Detailed Description

DLBCL is a highly common malignant tumor in Asia. The aim of the study is to observe and explore the clinical information on DLBCL patients with different genetic subtypes and to analyze the clinical characteristics and prognosis of different molecular subtypes of DLBCL. This study is a non-interventional real world, observational study and all registered data are collected from real clinical practice cases. The medical data includes patient demographic, tumor characteristics, laboratory examination, history of treatments, adverse reactions, efficacy results and possible prognostic factors. The results can guide future precision therapy for DLBCL.

Study Timeline

• Study First Submitted: 2023-08-17
• Study First Submitted QC: 2023-09-06
• Study First Posted: 2023-09-07
• Study Start: 2023-10-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-19
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

• Histologically-confirmed diffuse large B-cell lymphoma (DLBCL)
• Genetic subtype belonging to at least one of the seven subtypes by using next generation sequencing: MCD, BN2, N1, ST2, A53, EZB (MYC+, MYC-) and others
• Fully comprehension and signature of the informed consent form (ICF) for participation

Exclusion Criteria

• Those who refuse to use reliable methods of contraception during pregnancy, lactation or age-appropriate period
• Severe mental illness
• Patients deemed unsuitable for inclusion by the investigator

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All enrolled patients	Other	All patient who signed the consent form for participation to the study

Primary Outcome Measures

Name	Time	Method
PFS	Baseline up to data cut-off (Up to approximately 9 years)	Progression-free survival (PFS) is defined as the time from the date of first administration to the date of first disease progression or death from any cause, whichever occurs first.

Secondary Outcome Measures

Name	Time	Method
DOR	Baseline up to data cut-off (Up to approximately 9 years)	Duration Of Remission (DOR) refers to the time from the first CR or PR to the time of the first PD or death from any cause
OS	Baseline up to data cut-off (Up to approximately 9 years)	Overall survival (OS) refers to the time from receiving the first dose to death from any cause
TTR	Approximately up to 1 year	Time to remission (TTR) refers to the time from recruitment to the time first CR or PR
ORR	End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]	Objective Remission Rate (ORR) is defined as the proportion of patients with complete remission (CR) and partial remission (PR)
CRR	End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]	Complete Remission Rate (CRR) is defined as the proportion of patients with CR

Trial Locations

Locations (1)

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