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Not yet recruitingNCT07657572EXCELLENTUpdated Jun 18, 2026

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

An observational study in PTCL and T Cell Lymphoma, sponsored by Ruijin Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-18.

Sponsored by Ruijin Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • PTCL
  • T Cell Lymphoma

Keywords

  • Peripheral T Cell Lymphoma
  • molecular subtypes
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In context

Lymphoma, T-Cell

718 studies on the registry are indexed under Lymphoma, T-Cell; 120 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 174 across 57 observational studies indexed under Lymphoma, T-Cell.

Browse Lymphoma, T-Cell studies →

Lead sponsor

Ruijin Hospital is the lead sponsor of 635 studies on the registry; 359 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No
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What researchers measure

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.

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

Secondary outcomes

  1. 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]

  2. 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]

  3. 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)

  4. Duration of response

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

  5. Time to Response

    Time to Response (TTR): Defined as the time from subject enrollment to the first achievement of response (CR or PR).

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

  6. 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.

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

  7. Effects of biomarkers such as gene mutations on treatment response and survival outcomes

    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)

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07657572
Lead sponsor
Ruijin Hospital
Responsible party
Zhao Weili (Vice president of Ruijin Hospital, Ruijin Hospital) — Principal investigator
First posted
Jun 18, 2026
Start date
Jun 2026 (estimated)
Primary completion
Dec 2029 (estimated)
Completion
Dec 2030 (estimated)
Last update
Jun 18, 2026

Study contacts

Weili Zhao
Contact
zwl_trial@163.com
086-022-64370045
Pengpeng Xu
Contact
pengpeng_xu@126.com

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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