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| Name | Class |
|---|---|
| West China Hospital | OTHER |
| Shandong Provincial Hospital | OTHER_GOV |
| RenJi Hospital | OTHER |
| Xinhua Hospital, Shanghai Jiao Tong University School of Medicine |
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A multi-center, prospective, registry study to analyze the clinical characteristics and prognosis of different molecular subtypes of peripheral T-cell lymphoma.
Peripheral T-cell lymphoma (PTCL）is a distinct and heterogeneous histopathologic subtype of non-Hodgkin lymphoma (NHL), accounting for ~10%. Patients with PTCL still have poor treatment response and prognosis under conventional CHOP regimen. This multi-center, prospective, registry study is designed to analyze the clinical characteristics and prognosis of different molecular subtypes of PTCL. The results can guide future precision therapy for PTCL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gene mutation profile of PTCL | 84-gene penal was targeted sequenced in 1000 PTCL patients to investigate their mutation profile and molecular subtypes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 84-gene penal | Genetic | 84-gene penal was targeted sequenced in 1000 PTCL patients to investigate their mutation profile and molecular subtypes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Progression-free survival was defined as the time from the date of randomization until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first. | Baseline up to data cut-off (up to approximately 2 years) |
| Measure | Description | Time Frame |
|---|---|---|
| complete response rate | Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria. | End of treatment visit (usually 6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days] |
| Overall response rate |
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Inclusion Criteria:
Exclusion Criteria:
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The investigators reviewed previous PTCL genomics and PTCL registry studies worldwide. And the number of PTCL patients admitted to each center per year was investigated. Sample of 1000 PTCL patients was suitable and able to obtain a statistical significant result.
| 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 |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijing | 100044 | China |
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| ID | Term |
|---|---|
| D016411 | Lymphoma, T-Cell, Peripheral |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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| OTHER |
| Tianjin Medical University Cancer Institute and Hospital | OTHER |
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Targeted sequencing was performed in fresh tissue or FFPE tissue quality controlled.
Percentage of participants with overall response was determined on the basis of investigator assessments according to 2014 Lugano criteria |
| End of treatment visit (usually 6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days] |
| Overall survival | Overall survival was defined as the time from the date of diagnosis to the date of death from any cause. Reported is the percentage of participants with event. of disease progression or relapse, using 2014 Lugano criteria,or death from any cause, whichever occurred first. | Baseline up to data cut-off (up to approximately 4 years) |
| Duration of response | Time from first occurrence of documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR. Tumor assessments were performed with PET-CT. | Baseline up to data cut-off (up to approximately 4 years) |
| Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | Baseline up to data cut-off (up to approximately 4 years) |
| Tumor tissue gene mutations analysis | Targeted sequencing was used to detect 84 genes which can classify PTCL patients into different molecular subtypes. | Baseline up to data cut-off (up to approximately 4 years) |
| Circulating free Deoxyribonucleic Acid (cfDNA) monitoring | CfDNA in peripheral blood assessed by local lab | Baseline up to data cut-off (up to approximately 4 years) |
| Henan Cancer Hospital | Recruiting | Henan | 450003 | China |
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| Affiliated Drum Tower Hospital, Medical School of Nanjing University | Recruiting | Nanjing | 210008 | China |
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| Department of Hematology, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, China | Not yet recruiting | Shandong | China |
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| Shanghai Institute of Hematology, Rui-Jin Hospital affiliated to Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | 200025 | China |
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| Department of Hematology, West China Hospital, Sichuan University, Chengdu, Sichuan, China | Recruiting | Sichuan | China |
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| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |