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

Peripheral T Cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05934864
• Other study ID #: RJ-PTCL-3
• Status: Recruiting
• Start date: July 13, 2023
• Est. completion date: June 1, 2026

Study information

• Verified date: May 2024
• Source: Ruijin Hospital
• Contact: Weili Zhao
• Phone: +862164370045
• Email: zwl_trial[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

A multi-center, prospective, registry study to analyze the clinical characteristics and prognosis of different molecular subtypes of peripheral T-cell lymphoma.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 1, 2026
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• Peripheral T Cell Lymphoma

Intervention

Genetic:
• 84-gene penal
84-gene penal was targeted sequenced in 1000 PTCL patients to investigate their mutation profile and molecular subtypes.

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing
China	Henan Cancer Hospital	Henan
China	Affiliated Drum Tower Hospital, Medical School of Nanjing University	Nanjing
China	Department of Hematology, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, China	Shandong
China	Shanghai Institute of Hematology, Rui-Jin Hospital affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai
China	Department of Hematology, West China Hospital, Sichuan University, Chengdu, Sichuan, China	Sichuan

Sponsors (6)

Lead Sponsor	Collaborator
Ruijin Hospital	RenJi Hospital, Shandong Provincial Hospital, Tianjin Medical University Cancer Institute and Hospital, West China Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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]
Secondary	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]
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)