Real-World Study of DLBCL With Different Genetic Subtypes

Sponsor

Ruijin Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06026488

Collaborator

(none)

10,000

Enrollment

Location

Anticipated Duration (Months)

256.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
DLBCL - Diffuse Large B Cell Lymphoma Lymphoma	Other: Other

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

10000 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

A Real-World Study of Diffuse Large B-Cell Lymphoma (DLBCL) Patients With Different Genetic Subtypes

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2026

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
All enrolled patients All patient who signed the consent form for participation to the study	Other: Other real world treatment and survival of DLBCL patients in China

Arm

Intervention/Treatment

All enrolled patients

All patient who signed the consent form for participation to the study

Other: Other

real world treatment and survival of DLBCL patients in China

Outcome Measures

Primary Outcome Measures

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

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
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
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
TTR [Approximately up to 1 year]
Time to remission (TTR) refers to the time from recruitment to the time first CR or PR

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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