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.
Study Type
OBSERVATIONAL
Enrollment
1,000
84-gene penal was targeted sequenced in 1000 PTCL patients to investigate their mutation profile and molecular subtypes.
Peking University People's Hospital
Beijing, China
RECRUITINGHenan Cancer Hospital
Henan, China
RECRUITINGAffiliated Drum Tower Hospital, Medical School of Nanjing University
Nanjing, China
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.
Time frame: Baseline up to data cut-off (up to approximately 2 years)
complete response rate
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Baseline up to data cut-off (up to approximately 4 years)
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Department of Hematology, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, China
Shandong, China
NOT_YET_RECRUITINGShanghai Institute of Hematology, Rui-Jin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China
RECRUITINGDepartment of Hematology, West China Hospital, Sichuan University, Chengdu, Sichuan, China
Sichuan, China
RECRUITINGAn 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.
Time frame: 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.
Time frame: 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
Time frame: Baseline up to data cut-off (up to approximately 4 years)