Real-World Study of DLBCL With Different Genetic Subtypes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Other.
- Who it may be relevant to
- Registry conditions: DLBCL - Diffuse Large B Cell Lymphoma, Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Real-World Study of Diffuse Large B-Cell Lymphoma (DLBCL) Patients With Different Genetic Subtypes
Overview
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.
Interventions
- Other Other
real world treatment and survival of DLBCL patients in China
Primary outcome measures
- PFS [Time frame: Baseline up to data cut-off (Up to approximately 9 years)]
Secondary outcome measures (5)
- ORR [Time frame: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]]
- CRR [Time frame: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]]
- OS [Time frame: Baseline up to data cut-off (Up to approximately 9 years)]
- DOR [Time frame: Baseline up to data cut-off (Up to approximately 9 years)]
- TTR [Time frame: Approximately up to 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai
Identifiers
NCT: NCT06026488 · DLBCL-RWS-01