Different Molecular Subtypes of Peripheral T-cell Lymphoma, a Real-world Registry Study. (TRUST)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Different Molecular Subtypes of Peripheral T-cell Lymphoma, a Real-world Registry Study. (TRUST Study)

Conditions
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Peripheral T Cell Lymphoma

Intervention / Treatment
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* Genetic: 84-gene penal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with peripheral T-cell lymphoma (PTCL) by histopathology from June 2023 to December 2026 and detected by gene sequencing (NGS) with different molecular subtypes. Patients diagnosed with PTCL by histopathology from January 2023 to June 2023 and NGS detection can be performed if there is tumor tissue. Informed consented Age ≥ 18 years Exclusion Criteria: History of malignancy except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix prior to study treatment Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease Not able to comply to the protocol for mental or other unknown reasons Patients with mentally disorders or other reasons unable to fully comply with the study protocol Pregnant or lactation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Gene mutation profile of PTCL<br>84-gene penal was targeted sequenced in 1000 PTCL patients to investigate their mutation profile and molecular subtypes. | Genetic: 84-gene penal<br>* 84-gene penal was targeted sequenced in 1000 PTCL patients to investigate their mutation profile and molecular subtypes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral T Cell Lymphoma, molecular subtypes