A Multi-center, Prospective, Registry Study to Analyze the Clinical Characteristics and Prognosis of Different Molecular Subtypes of Peripheral T-cell Lymphoma.

NCT07657572 | Not Yet Recruiting DMC

• 1 other identifier: EXCELLENT
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

PTCL; T Cell Lymphoma

Keywords

Peripheral T Cell Lymphoma; molecular subtypes

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  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 4 years)

Secondary Outcomes (7)

• Overall response rate

  End of treatment visit (usually 6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]

• Complete response rate

  End of treatment visit (usually 6-8 weeks after last dose on Day 1 of Cycle 6 Cycle length=21 days]

• Overall survival

  Baseline up to data cut-off (up to approximately 4 years)

• Duration of response

  Baseline up to data cut-off (up to approximately 4 years)

• Time to Response

  Baseline up to data cut-off (up to approximately 4 years)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The investigators reviewed previous PTCL genomics and PTCL registry studies worldwide. And the number of PTCL patients admitted to each center per year was investigated. Sample of 1000 PTCL patients was suitable and able to obtain a statistical significant result.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

MeSH Terms

Conditions

Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Weili Zhao

CONTACT

086-022-64370045; zwl_trial@163.com

Pengpeng Xu

CONTACT

pengpeng_xu@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice president of Ruijin Hospital

Study Record Dates

• First Submitted: June 14, 2026
• First Posted: June 18, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: June 18, 2026

Record last verified: 2026-06