PTCL, T Cell Lymphoma
Conditions
Keywords
Peripheral T Cell Lymphoma, molecular subtypes
Brief summary
A multi-center, prospective, registry study to analyze the clinical characteristics and prognosis of different molecular subtypes of peripheral T-cell lymphoma.
Detailed description
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.
Interventions
None listed
Sponsors
Ruijin Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with peripheral T-cell lymphoma (PTCL) by histopathology from June 2026 to December 2029 and detected by gene sequencing (NGS) with different molecular subtypes. * Patients diagnosed with PTCL by histopathology from January 2026 to June 2026 and NGS detection can be performed if there is tumor tissue. * Fully understand the study, voluntarily sign the written informed consent form (ICF), and agree to cooperate with genetic testing, treatment, efficacy assessment and long-term follow-up. * Age ≥ 18 years
Exclusion criteria
* Female patients who are pregnant, breastfeeding, or of childbearing potential without effective contraception; * Subjects with poorly controlled neurological, psychiatric, mental or cognitive disorders that may impair their understanding and signing of the informed consent form as well as adherence to the study procedures; * Any other conditions deemed inappropriate for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | Baseline up to data cut-off (up to approximately 4 years) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate | End of treatment visit (usually 6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days] | Percentage of participants with overall response was determined on the basis of investigator assessments according to 2014 Lugano criteria |
| Complete response rate | End of treatment visit (usually 6-8 weeks after last dose on Day 1 of Cycle 6 Cycle length=21 days] | Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria. |
| Overall survival | Baseline up to data cut-off (up to approximately 4 years) | 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. |
| Duration of response | Baseline up to data cut-off (up to approximately 4 years) | ime 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. |
| Time to Response | Baseline up to data cut-off (up to approximately 4 years) | Time to Response (TTR): Defined as the time from subject enrollment to the first achievement of response (CR or PR). |
| Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE | Baseline up to data cut-off (up to approximately 4 years) | 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. |
| Effects of biomarkers such as gene mutations on treatment response and survival outcomes | Baseline up to data cut-off (up to approximately 4 years) | Targeted sequencing was used to detect 84 genes which can classify PTCL patients into different molecular subtypes. |
Contacts
CONTACTWeili Zhao
CONTACTPengpeng Xu
Outcome results
None listed