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To collect and evaluate the data of real-world treatment regimen, efficacy, safety and survival information of DLBCL patients with different genetic suptypes
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All enrolled patients | All patient who signed the consent form for participation to the study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Other | Other | real world treatment and survival of DLBCL patients in China |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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] |
| CRR |
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Inclusion Criteria:
Exclusion Criteria:
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DLBCL patients with genetic subtypes belonging to one of the seven subtypes by NGS: MCD, BN2, N1, ST2, A53, EZB (MYC+, MYC-) and others
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weili Zhao | Contact | +862164370045 | 610707 | zwl_trial@163.com |
| Pengpeng Xu | Contact | +862164370045 | 610707 | pengpeng_xu@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital, Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200025 | China |
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| ID | Term |
|---|---|
| D054739 | Dendritic Cell Sarcoma, Interdigitating |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D015620 | Histiocytic Disorders, Malignant |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D015614 | Histiocytosis |
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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] |
| 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) |
| 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) |
| TTR | Time to remission (TTR) refers to the time from recruitment to the time first CR or PR | Approximately up to 1 year |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |