Real-World Study of DLBCL With Different Genetic Subtypes

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06026488
• Other study ID #: DLBCL-RWS-01
• Status: Not yet recruiting
• Start date: October 1, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: September 2023
• Source: Ruijin Hospital
• Contact: Weili Zhao
• Phone: +862164370045
• Email: zwl_trial[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10000
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Other:
• Other
real world treatment and survival of DLBCL patients in China

Locations

Country	Name	City	State
China	Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

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