DLBCL - Diffuse Large B Cell Lymphoma, Lymphoma
Conditions
Keywords
lymphoma, DLBCL, Genetic Subtype, real world analysis
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
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
OTHEROther
real world treatment and survival of DLBCL patients in China
Sponsors
Ruijin Hospital
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactWeili Zhao
Backup ContactPengpeng Xu
Outcome results
None listed