PTCLEXCELLENTNCT07657572
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 of PTCL and T Cell Lymphoma, run by Ruijin Hospital.
Trial summary
A multi-center, prospective, registry study to analyze the clinical characteristics and prognosis of different molecular subtypes of peripheral T-cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTCL, T Cell Lymphoma
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Pengpeng Xu contact
About this study
Official title: Different Molecular Subtypes of Peripheral T-cell Lymphoma, a Real-world Registry Study. (EXCELLENT Study)
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.
- Conditions
- PTCL, T Cell Lymphoma
- Keywords
- Peripheral T Cell Lymphoma, molecular subtypes
- Medical subject headings
- Lymphoma, T-Cell, Lymphoma, T-Cell, Peripheral
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to data cut-off (up to approximately 4 years)
Secondary outcomes (7)
Overall response rate
Percentage of participants with overall response was determined on the basis of investigator assessments according to 2014 Lugano criteria
Measured: End of treatment visit (usually 6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]
Complete response rate
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
Measured: 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.
Measured: Baseline up to data cut-off (up to approximately 4 years)
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.
Measured: Baseline up to data cut-off (up to approximately 4 years)
Time to Response
Time to Response (TTR): Defined as the time from subject enrollment to the first achievement of response (CR or PR).
Measured: Baseline up to data cut-off (up to approximately 4 years)
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.
Measured: Baseline up to data cut-off (up to approximately 4 years)
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.
Measured: Baseline up to data cut-off (up to approximately 4 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTCLStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Weili, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07657572
- Sponsor's protocol ID
- EXCELLENT
- Acronym
- EXCELLENT
- Status last verified
- Jun 2026
- First submitted
- 14 Jun 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Molecular Subtypes of Peripheral T-cell Lymphoma, a Real-world Registry Study. (EXCELLENT Study)
- ClinicalTrials.gov ID
- NCT07657572
- Acronym / sponsor ID
- EXCELLENT / EXCELLENT
- Conditions
- PTCL, T Cell Lymphoma
- Keywords
- Peripheral T Cell Lymphoma, molecular subtypes
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multi-center, prospective, registry study to analyze the clinical characteristics and prognosis of different molecular subtypes of peripheral T-cell lymphoma.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
7 secondary outcomes
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]
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]
Overall survival
Time frame: Baseline up to data cut-off (up to approximately 4 years)
Duration of response
Time frame: Baseline up to data cut-off (up to approximately 4 years)
Time to Response
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
Time frame: Baseline up to data cut-off (up to approximately 4 years)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pengpeng Xu contact
Questions about this trial
What is this clinical trial studying?
An observational study of PTCL and T Cell Lymphoma, run by Ruijin Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weili Zhao (086-022-64370045, zwl_trial@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: Baseline up to data cut-off (up to approximately 4 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026; AzTrials last refreshed its copy on 4 Nov 2026.