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NCT Number: NCT07657572

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Primary outcomes

  1. Progression-free survival

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

    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.

Secondary outcomes

  1. Overall response rate

    Time frame: 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

  2. Complete response rate

    Time frame: 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.

  3. Overall survival

    Time frame: 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.

  4. Duration of response

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

    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.

  5. Time to Response

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

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

  6. Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE

    Time frame: 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.

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Pengpeng Xu

CONTACT

[email protected]

Weili Zhao

CONTACT

[email protected]

086-022-64370045

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

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

Acronym: EXCELLENT

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Jun 18, 2026
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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