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NCT Number: NCT06026488

Real-World Study of DLBCL With Different Genetic Subtypes

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

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Key information

Conditions

DLBCL - Diffuse Large B Cell Lymphoma Dendritic Cell Sarcoma, Interdigitating Hemic and Lymphatic Diseases Histiocytic Disorders, Malignant Histiocytosis Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location status: Recruiting

Location contact

Pengpeng Xu, MD, PhD

CONTACT

[email protected]

Weili Zhao, MD, PhD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

other

Other

real world treatment and survival of DLBCL patients in China

Primary outcomes

  1. PFS

    Time frame: 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 outcomes

  1. ORR

    Time frame: 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)

  2. CRR

    Time frame: 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

  3. OS

    Time frame: 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

  4. DOR

    Time frame: 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

  5. TTR

    Time frame: Approximately up to 1 year

    Time to remission (TTR) refers to the time from recruitment to the time first CR or PR

Study contacts

Contact information is provided by the study sponsor or research team.

Pengpeng Xu

CONTACT

[email protected]

+862164370045 ext. 610707

Weili Zhao

CONTACT

[email protected]

+862164370045 ext. 610707

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 7, 2023
Registry last updated
Dec 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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