Peripheral 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
GENETIC84-gene penal
84-gene penal was targeted sequenced in 1000 PTCL patients to investigate their mutation profile and molecular subtypes.
Sponsors
West China Hospital
Shandong Provincial Hospital
RenJi Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Tianjin Medical University Cancer Institute and Hospital
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | Baseline up to data cut-off (up to approximately 2 years) | 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 |
| 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) | 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. |
| 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. |
| Tumor tissue gene mutations analysis | 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. |
| Circulating free Deoxyribonucleic Acid (cfDNA) monitoring | Baseline up to data cut-off (up to approximately 4 years) | CfDNA in peripheral blood assessed by local lab |
| 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. |
Countries
China
Contacts
Primary ContactWeili Zhao
Backup ContactPengpeng Xu
Outcome results
None listed