Real-World Study of DLBCL With Different Genetic Subtypes

NCT06026488 | Recruiting

• 1 other identifier: DLBCL-RWS-01
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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

Conditions

DLBCL - Diffuse Large B Cell Lymphoma; Lymphoma

Keywords

lymphoma; DLBCL; Genetic Subtype; real world analysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• ORR

  End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]

• CRR

  End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]

• OS

  Baseline up to data cut-off (Up to approximately 9 years)

• DOR

  Baseline up to data cut-off (Up to approximately 9 years)

• TTR

  Approximately up to 1 year

Study Arms (1)

All enrolled patients

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

Other: Other

Interventions

Other OTHER

real world treatment and survival of DLBCL patients in China

All enrolled patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

DLBCL patients with genetic subtypes belonging to one of the seven subtypes by NGS: MCD, BN2, N1, ST2, A53, EZB (MYC+, MYC-) and others

You may qualify if:

• 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

You may not qualify if:

• Those who refuse to use reliable methods of contraception during pregnancy, lactation or age-appropriate period
• Severe mental illness

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Dendritic Cell Sarcoma, Interdigitating; Lymphoma

Condition Hierarchy (Ancestors)

Histiocytic Disorders, Malignant; Neoplasms by Histologic Type; Neoplasms; Histiocytosis; Lymphatic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Weili Zhao

CONTACT

+862164370045; zwl_trial@163.com

Pengpeng Xu

CONTACT

+862164370045; pengpeng_xu@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: September 7, 2023
• Study Start: October 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 19, 2024

Record last verified: 2024-12

Locations

CN (1)