Peripheral T Cell LymphomaT-START-NRNCT07470996
T Cell Lymphoma -Stratified Therapy After Response to First-line Treatment-NR
An observational study of Peripheral T Cell Lymphoma, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
This study is a multicenter, two-arm, prospective clinical trial, comprising two groups: the allogeneic hematopoietic stem cell transplantation group (Allo-HSCT) and the alternative salvage regimens. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Peripheral T Cell Lymphoma
- What is being tested?
- Allogenic stem cell transplant (ASCT) and Salvage Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2025to 30 Sep 2029
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients with peripheral T-cell lymphoma that has achieved no response (NR) after first-line therapy.
Who may be able to join
- At the time of ICF signing, the subject must be 18-70 years of age, inclusive, regardless of gender.
- The subject must have achieved Stable Disease (SD) or Progressive Disease (PD) as assessed per the Lugano 2014 classification criteria after first-line systemic standard therapy (CHOP or a CHOP-like regimen). This includes subjects who failed to achieve a response after at least 4 cycles of standard chemotherapy or who experienced disease progression during treatment.
- The subject must have a histologically confirmed diagnosis of PTCL according to the 2016 revised WHO classification of lymphoid neoplasms (Swerdlow SH et al. 2016). Eligible histological subtypes are restricted to the following: Not Otherwise Specified (PTCL-NOS); ALK-negative Anaplastic Large Cell Lymphoma (ALK- ALCL); Follicular Helper T-cell Lymphoma or PTCL with a TFH phenotype (FTCL or PTCL-TFH). Additionally, they must meet the following condition:
- Patients scheduled for allogeneic hematopoietic stem cell transplantation must have a suitable stem cell donor:
- Related donors must be at least 5/10 matched at HLA-A, -B, -C, -DQB1, and -DRB1.
- Unrelated donors must be at least 8/10 matched at HLA-A, -B, -C, -DQB1, and -DRB1.
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- Hematopoietic Cell Transplantation-Specific Comorbidity Index (HCT-CI) score ≤ 2.
- ECOG Performance Status score of 0 or 1, with no deterioration over the preceding two weeks.
- Life expectancy of at least 12 weeks.
- Adequate hepatic, renal, cardiac, and pulmonary function, defined as:
- Hepatic: Serum total bilirubin ≤ 2 × ULN (or ≤ 3.0 × ULN in cases of Gilbert's syndrome or documented baseline liver involvement); Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 2.5 × ULN (or ≤ 5.0 × ULN in cases of liver involvement).
- Renal: Serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL/min as calculated by the Cockcroft-Gault formula or measured.
- Cardiac: Left Ventricular Ejection Fraction (LVEF) ≥ 50% as measured by Multigated Acquisition (MUGA) scan or Echocardiography (ECHO).
- Baseline oxygen saturation on room air > 92%. v. Pulmonary: Diffusing capacity of the lungs for carbon monoxide (DLCO), corrected for hemoglobin, ≥ 40% and Forced Expiratory Volume in 1 second (FEV1) ≥ 50% of predicted.
- Voluntary participation in the clinical study; full understanding and awareness of the study and having signed the ICF; willingness and ability to comply with and complete all trial procedures.
Who cannot join
- Ann Arbor Stage I disease.
- History of any other malignancy within the past 5 years, except for locally cured malignancies after radical therapy (e.g., basal cell or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast).
- Active infection, including:
- Known active or latent tuberculosis, indicated by a positive tuberculin (PPD) skin test (defined as induration >10 mm or per local clinical criteria) or radiographic findings on chest X-ray/CT suggestive of active/latent TB.
- Known history of Human Immunodeficiency Virus (HIV) infection and/or Acquired Immunodeficiency Syndrome (AIDS).
- Chronic active hepatitis B or C infection:
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- Hepatitis B virus (HBV) DNA-positive subjects are excluded; those with undetectable HBV-DNA are eligible. The upper limit of normal (ULN) for HBV-DNA is as defined by each participating center.
- Hepatitis C virus (HCV) RNA-positive subjects are excluded; those with undetectable HCV-RNA are eligible. The ULN for HCV-RNA is as defined by each participating center.
- Active viral infections other than hepatitis B or C (e.g., herpes zoster, cytomegalovirus).
- Infection requiring intravenous antimicrobial therapy, evidenced by: hemodynamic instability related to infection, worsening or new infectious symptoms/signs, new infectious foci on imaging, or persistent fever without localizing signs where infection cannot be ruled out.
- Positive serum DNA test for Epstein-Barr virus (EBV).
- Poorly controlled cardiac symptoms or diseases, including:
- Heart failure > New York Heart Association (NYHA) Class II. ii. Unstable angina. iii. Myocardial infarction within the past year. iv. Clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention.
- Pregnant or lactating women, and subjects of childbearing potential unwilling to use effective contraception.
- Patients with psychiatric disorders or those unable to provide informed consent.
- PTCL patients with central nervous system involvement.
- PTCL patients who have received prior PD-1/PD-L1 inhibitor therapy.
- Any other condition that, in the investigator's judgment, renders the subject unsuitable for study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080
xianmin Song, MD, 86-21-63240090 ext. 3172, shongxm@sjtu.edu.cn
About this study
This study is a multicenter, two-arm, prospective clinical trial, comprising two groups: the allogeneic hematopoietic stem cell transplantation group (Allo-HSCT) and the alternative salvage regimens. It aims to evaluate the efficacy and safety of Allo-HSCT and alternative salvage regimens in the treatment of peripheral T-cell lymphoma that has achieved no response (NR) after first-line therapy. During the screening/baseline period, informed consent will be obtained, and inclusion/exclusion criteria will be verified. Group assignment (Allo-HSCT vs. alternative salvage regimens) will be determined taking into account the availability of a matched donor and the patient's preference. The study plans to enroll 29 patients in each group. Data on demographics and medical history will be collected, and assessments including vital signs, physical examination, PET-CT, bone marrow aspiration smear, flow cytometry, and bone marrow pathology will be performed.
- Conditions
- Peripheral T Cell Lymphoma
- Being tested
- Allogenic stem cell transplant (ASCT), Salvage Therapy
- Keywords
- Peripheral T Cell Lymphoma, no response, allogeneic hematopoietic stem cell transplantation, alternative salvage regimens
- Medical subject headings
- Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogenic stem cell transplant (ASCT)Procedure or surgery
ASCT involves the infusion of stem cells collected from a donor (genetically similar, but not identical).
Salvage TherapyProcedure or surgery
This term encompasses a range of potential alternative regimens instead of allogeneic hematopoietic stem cell transplantation
| Study group | Role | What they receive |
|---|---|---|
| Allo-HSCT | Allo-HSCT involves the infusion of stem cells collected from a donor (genetically similar, but not identical). Receives: Procedure: Allogenic stem cell transplant (ASCT) | |
| the alternative salvage regimens | This term encompasses a range of potential alternative regimens instead of allogeneic hematopoietic stem cell transplantation Receives: Procedure: Salvage Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
2y-overall survival (OS)
The probability of survival at 2 years, measured from the date of transplantation to death from any cause. Patients who are still alive at the time of analysis will be censored on the last follow-up date.
Measured: up to 2 years for the 2y-OS
Secondary outcomes (2)
2y-progression-free survival (PFS)
Progression-Free Survival (PFS) is defined as the time from transpalntation until the first occurrence of disease progression or death from any cause, whichever occurs earlier.
Measured: up to 2 years for the 2y-PFS
non-relapse mortality (NRM)
Death occurring after transplantation due to causes other than disease relapse, such as infection, organ toxicity, or transplantation-related complications. Deaths from any cause in the absence of prior relapse are considered events for this endpoint
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start1 Oct 2025
- Primary completion30 May 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peripheral T Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- 58 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai Cancer Centre, Ruijin Hospital
- Responsible party
- Principal investigator, Xianmin Song, MD, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07470996
- Sponsor's protocol ID
- SHSYXYK-PTCL-NR-Prospective
- Acronym
- T-START-NR
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tournilhac O, Altmann B, Friedrichs B, Bouabdallah K, Leclerc M, Cartron G, Turlure P, Reimer P, Wagner-Drouet E, Sanhes L, Houot R, Roussel M, Kroschinsky F, Dreger P, Viardot A, de Leval L, Rosenwald A, Gaulard P, Wulf G, Villate A, Latiere C, Elmaagacli A, Glass B, Poeschel V, Damaj G, Sibon D, Durot E, Bilger K, Banos A, Haenel M, Dreyling M, Keller U, Tiab M, Drenou B, Cornillon J, Nguyen S, Robin M, Nickelsen M, Trumper L, Lenz G, Ziepert M, Schmitz N; French Lymphoma Study Association (LYSA), the Societe Francophone de greffe de moelle et Therapie Cellulaire (SFGM-TC), and the German Lymphoma Alliance (GLA). Long-Term Follow-Up of the Prospective Randomized AATT Study (Autologous or Allogeneic Transplantation in Patients With Peripheral T-Cell Lymphoma). J Clin Oncol. 2024 Nov 10;42(32):3788-3794. doi: 10.1200/JCO.24.00554. Epub 2024 Sep 13.
PubMed 39270145Schmitz N, Truemper L, Bouabdallah K, Ziepert M, Leclerc M, Cartron G, Jaccard A, Reimer P, Wagner E, Wilhelm M, Sanhes L, Lamy T, de Leval L, Rosenwald A, Roussel M, Kroschinsky F, Lindemann W, Dreger P, Viardot A, Milpied N, Gisselbrecht C, Wulf G, Gyan E, Gaulard P, Bay JO, Glass B, Poeschel V, Damaj G, Sibon D, Delmer A, Bilger K, Banos A, Haenel M, Dreyling M, Metzner B, Keller U, Braulke F, Friedrichs B, Nickelsen M, Altmann B, Tournilhac O. A randomized phase 3 trial of autologous vs allogeneic transplantation as part of first-line therapy in poor-risk peripheral T-NHL. Blood. 2021 May 13;137(19):2646-2656. doi: 10.1182/blood.2020008825.
PubMed 33512419
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- T Cell Lymphoma -Stratified Therapy After Response to First-line Treatment-NR
- ClinicalTrials.gov ID
- NCT07470996
- Acronym / sponsor ID
- T-START-NR / SHSYXYK-PTCL-NR-Prospective
- Conditions
- Peripheral T Cell Lymphoma
- Keywords
- Peripheral T Cell Lymphoma, no response, allogeneic hematopoietic stem cell transplantation, alternative salvage regimens
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai Cancer Centre, Ruijin Hospital
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 30 May 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 13 Mar 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.
This study is a multicenter, two-arm, prospective clinical trial, comprising two groups: the allogeneic hematopoietic stem cell transplantation group (Allo-HSCT) and the alternative salvage regimens. It aims to evaluate the efficacy and safety of Allo-HSCT and alternative salvage regimens in the treatment of peripheral T-cell lymphoma that has achieved no response (NR) after first-line therapy. During the screening/baseline period, informed consent will be obtained, and inclusion/exclusion criteria will be verified. Group assignment (Allo-HSCT vs. alternative salvage regimens) will be determined taking into account the availability of a matched donor and the patient's preference. The study plans to enroll 29 patients in each group. Data on demographics and medical history will be collected, and assessments including vital signs, physical examination, PET-CT, bone marrow aspiration smear, flow cytometry, and bone marrow pathology will be performed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allo-HSCT | – | Procedure: Allogenic stem cell transplant (ASCT)Allo-HSCT involves the infusion of stem cells collected from a donor (genetically similar, but not identical). |
| the alternative salvage regimens | – | Procedure: Salvage TherapyThis term encompasses a range of potential alternative regimens instead of allogeneic hematopoietic stem cell transplantation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients with peripheral T-cell lymphoma that has achieved no response (NR) after first-line therapy.
Key inclusion criteria (15 listed)
- At the time of ICF signing, the subject must be 18-70 years of age, inclusive, regardless of gender.
- The subject must have achieved Stable Disease (SD) or Progressive Disease (PD) as assessed per the Lugano 2014 classification criteria after first-line systemic standard therapy (CHOP or a CHOP-like regimen). This includes subjects who failed to achieve a response after at least 4 cycles of standard chemotherapy or who experienced disease progression during treatment.
- The subject must have a histologically confirmed diagnosis of PTCL according to the 2016 revised WHO classification of lymphoid neoplasms (Swerdlow SH et al. 2016). Eligible histological subtypes are restricted to the following: Not Otherwise Specified (PTCL-NOS); ALK-negative Anaplastic Large Cell Lymphoma (ALK- ALCL); Follicular Helper T-cell Lymphoma or PTCL with a TFH phenotype (FTCL or PTCL-TFH). Additionally, they must meet the following condition:
- Patients scheduled for allogeneic hematopoietic stem cell transplantation must have a suitable stem cell donor:
- Hematopoietic Cell Transplantation-Specific Comorbidity Index (HCT-CI) score ≤ 2.
Key exclusion criteria (18 listed)
- Ann Arbor Stage I disease.
- History of any other malignancy within the past 5 years, except for locally cured malignancies after radical therapy (e.g., basal cell or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast).
- Active infection, including:
- Poorly controlled cardiac symptoms or diseases, including:
- Pregnant or lactating women, and subjects of childbearing potential unwilling to use effective contraception.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allogenic stem cell transplant (ASCT)ASCT involves the infusion of stem cells collected from a donor (genetically similar, but not identical). | Procedure or surgery | Allo-HSCT |
| Salvage TherapyThis term encompasses a range of potential alternative regimens instead of allogeneic hematopoietic stem cell transplantation | Procedure or surgery | the alternative salvage regimens |
Primary outcome
2y-overall survival (OS)
Time frame: up to 2 years for the 2y-OS
The probability of survival at 2 years, measured from the date of transplantation to death from any cause. Patients who are still alive at the time of analysis will be censored on the last follow-up date.
2 secondary outcomes
2y-progression-free survival (PFS)
Time frame: up to 2 years for the 2y-PFS
non-relapse mortality (NRM)
Time frame: up to 1 year
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 13 Mar 2026.
- Background: PubMed 39270145Tournilhac O, Altmann B, Friedrichs B, Bouabdallah K, Leclerc M, Cartron G, Turlure P, Reimer P, Wagner-Drouet E, Sanhes L, Houot R, Roussel M, Kroschinsky F, Dreger P, Viardot A, de Leval L, Rosenwald A, Gaulard P, Wulf G, Villate A, Latiere C, Elmaagacli A, Glass B, Poeschel V, Damaj G, Sibon D, Durot E, Bilger K, Banos A, Haenel M, Dreyling M, Keller U, Tiab M, Drenou B, Cornillon J, Nguyen S, Robin M, Nickelsen M, Trumper L, Lenz G, Ziepert M, Schmitz N; French Lymphoma Study Association (LYSA), the Societe Francophone de greffe de moelle et Therapie Cellulaire (SFGM-TC), and the German Lymphoma Alliance (GLA). Long-Term Follow-Up of the Prospective Randomized AATT Study (Autologous or Allogeneic Transplantation in Patients With Peripheral T-Cell Lymphoma). J Clin Oncol. 2024 Nov 10;42(32):3788-3794. doi: 10.1200/JCO.24.00554. Epub 2024 Sep 13.
- Background: PubMed 33512419Schmitz N, Truemper L, Bouabdallah K, Ziepert M, Leclerc M, Cartron G, Jaccard A, Reimer P, Wagner E, Wilhelm M, Sanhes L, Lamy T, de Leval L, Rosenwald A, Roussel M, Kroschinsky F, Lindemann W, Dreger P, Viardot A, Milpied N, Gisselbrecht C, Wulf G, Gyan E, Gaulard P, Bay JO, Glass B, Poeschel V, Damaj G, Sibon D, Delmer A, Bilger K, Banos A, Haenel M, Dreyling M, Metzner B, Keller U, Braulke F, Friedrichs B, Nickelsen M, Altmann B, Tournilhac O. A randomized phase 3 trial of autologous vs allogeneic transplantation as part of first-line therapy in poor-risk peripheral T-NHL. Blood. 2021 May 13;137(19):2646-2656. doi: 10.1182/blood.2020008825.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral T Cell Lymphoma, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
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 15 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 xianmin song, MD (+862163240090, shongxm@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2y-overall survival (OS) (time frame: up to 2 years for the 2y-OS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07470996, which also lists 2 linked publications.
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 13 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.