AzTrials
AzTrials

Peripheral T Cell LymphomaT-START-PRNCT07253129

Allo-HSCT Vs. Auto-HSCT for PTCL Patients With PR After First-line Systemic Therapy : A Prospective, Multicenter, Cohort Study-(T-START-PR)

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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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 autologous hematopoietic stem cell transplantation group (Auto-HSCT). 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?
Autologous Hematopoietic Stem Cell Transplantation and Allogenic stem cell transplant (ASCT)
How many people
88 participants
Where
1 siteChina
Study dates
31 Dec 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: Patients with PTCL who are in PR following first-line therapy and who are both medically eligible and willing to undergo transplantation will be directly assigned to treatment with either allogeneic PBSCT or autologous HSCT.

Who may be able to join

  • Age \& Sex:
  • Males or females aged 18 to 70 years (inclusive).
  • ECOG performance status score of 0 to 1, with no deterioration within the last two weeks.
  • Expected survival period greater than 12 weeks.
  • Patients must have a histopathological confirmation of PTCL according to the 2016 revised WHO classification of lymphoid neoplasms (Swerdlow SH et al. 2016). Eligible histological subtypes are limited to the following:
  • Peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS)
Show all 19Show fewer
  • Anaplastic large cell lymphoma, ALK-negative (ALK-ALCL)
  • Follicular helper T-cell lymphoma or PTCL with TFH phenotype (FTCL or PTCL-TFH)
  • Patients undergoing allogeneic hematopoietic stem cell transplantation must have a suitable stem cell donor:
  • Related donors must be at least 5/10 matched for HLA-A, -B, -C, -DQB1, and -DRB1.
  • Unrelated donors must be at least 8/10 matched for HLA-A, -B, -C, -DQB1, and -DRB1.
  • Patients must have achieved a partial response (PR) as per the Lugano 2014 response criteria for lymphoma after six cycles of CHOP, BV-CHP or CHOP-like chemotherapy.
  • Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) score ≤ 2.
  • Adequate hepatic, renal, cardiac, and pulmonary function, defined as follows:
  • Hepatic function: Serum total bilirubin ≤ 2 × upper limit of normal (ULN) (≤ 3.0 × ULN in cases of Gilbert's syndrome or baseline hepatic involvement); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5.0 × ULN in cases of hepatic involvement).
  • Renal function: Serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL/min as calculated or measured by the Cockcroft-Gault method.
  • Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50% as measured by multigated acquisition (MUGA) scan or echocardiography (ECHO).
  • Baseline oxygen saturation > 92%.
  • Pulmonary function: Diffusing capacity of the lung for carbon monoxide (DLCO) (hemoglobin-corrected) ≥ 40% and forced expiratory volume in 1 second (FEV1) ≥ 50%.

Who cannot join

  • Ann Arbor clinical stage I disease.
  • History of malignancy within the past 5 years, except for locally curable malignancies that have been treated with curative intent (e.g., basal 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, evidenced by a positive tuberculin (PPD) skin test (induration >10 mm or per local criteria for a positive result) or radiographic findings suggestive of active/latent TB on chest X-ray/CT.
  • Known history of infection with Human Immunodeficiency Virus (HIV) and/or AIDS.
  • Chronic active hepatitis B or hepatitis C infection:
Show all 19Show fewer
  • <!-- -->
  • Patients positive for hepatitis B virus (HBV) DNA are excluded; however, those with undetectable HBV DNA levels are eligible. The upper limit of normal (ULN) for HBV DNA shall be based on the reference values of each participating center.
  • Patients positive for hepatitis C virus (HCV) RNA are excluded; however, those with undetectable HCV RNA are eligible. The ULN for HCV RNA shall be based on the reference values of each participating center.
  • Active viral infections other than hepatitis B or hepatitis C (e.g., herpes zoster, cytomegalovirus).
  • Infection requiring intravenous antimicrobial therapy, associated with hemodynamic instability, worsening or new onset of infectious signs/symptoms, or new infectious foci on imaging; or persistent fever without localizing signs that cannot rule out infection.
  • Positive serum DNA test for Epstein-Barr virus (EBV).
  • Poorly controlled cardiac symptoms or disease, such as:
  • Heart failure greater than 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.
  • Psychiatric illness or individuals unable to provide informed consent.
  • PTCL patients with central nervous system involvement.
  • PTCL patients who have previously received PD-1 inhibitor therapy.
  • Any other condition that, in the judgment of the investigator, would make the subject unsuitable for participation in this study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

xianmin song, MD contact

+862163240090

shongxm@139.com

China1 site, 1 recruiting

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality, 200080

    xianmin Song, MD, 86-21-63240090 ext. 3172, shongxm@sjtu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Allogeneic Hematopoietic Stem Cell Transplantation Versus Autologous Hematopoietic Stem Cell Transplantation for Peripheral T-cell Lymphoma Patients With Partial Remission After First-line Systemic Therapy : A Prospective, Multicenter, Cohort Study(T-START-PR)

This study is a multicenter, two-arm, prospective clinical trial, comprising two groups: the allogeneic hematopoietic stem cell transplantation group (Allo-HSCT) and the autologous hematopoietic stem cell transplantation group (Auto-HSCT). It aims to evaluate the efficacy and safety of Auto-HSCT and Allo-HSCT in the treatment of peripheral T-cell lymphoma that has achieved partial response (PR) 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. Auto-HSCT) will be determined taking into account the availability of a matched donor and the patient's preference. The study plans to enroll 44 patients in the allogeneic hematopoietic stem cell transplantation group, while all concurrent patients undergoing autologous stem cell transplantation will be included in the other group for inverse probability weighting analysis. 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.

Being tested
Autologous Hematopoietic Stem Cell Transplantation, Allogenic stem cell transplant (ASCT)
Keywords
peripheral T cell lymphoma, allogeneic hematopoietic stem cell transplantation, autologous hematopoietic stem cell transplantation, partial response
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.

  • Autologous Hematopoietic Stem Cell TransplantationProcedure or surgery

    Also called Auto-HSCT

    Auto-HSCT involves the infusion of the patient's own previously collected stem cells.

  • Allogenic stem cell transplant (ASCT)Procedure or surgery

    Also called ASCT, Allo-HSCT

    ASCT involves the infusion of stem cells collected from a donor (genetically similar, but not identical).

Study groups in NCT07253129
Study groupRoleWhat they receive
Allo-HSCTAllo-HSCT involves the infusion of stem cells collected from a donor (genetically similar, but not identical)
Receives: Procedure: Allogenic stem cell transplant (ASCT)
Auto-HSCTAuto-HSCT involves the infusion of the patient's own previously collected stem cells.
Receives: Procedure: Autologous Hematopoietic Stem Cell Transplantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 2y-event-free survival (EFS)

    2-year event-free survival (EFS) rates post-transplant. An event is defined as whichever of the following occurs first: disease progression, death from any cause, commencement of new anti-tumor therapy, or a treatment-related serious adverse event (specifically including disabling events or secondary neoplasms). Subjects who were event-free at the data cutoff will be censored on the date of their last tumor assessment.

    Measured: up to 2 years for the 2y-EFS

Secondary outcomes (4)

  1. 3m and 6m-complete response rate

    The duration from the date of hematopoietic stem cell transplantation to the first occurrence of complete response.

    Measured: up to 3 months for the 3m-CR and up to 6 months for the 6m-CR

  2. 1y and 2y-cumulative relapse rates (CIR)

    The cumulative probability of disease progression (including relapse or progression of the primary disease) within 1 or 2 years after transplantation, with non-progression-related death treated as a competing event.

    Measured: up to 1 years for the 1y-CIR and up to 2 years for the 2y-CIR

  3. 1y and 2y-overall survival (OS)

    The probability of survival at 1 or 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 1 years for the 1y-OS and up to 2 years for the 2y-OS

  4. 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 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Nov 2025
  2. Study start31 Dec 2025 (estimated)
  3. Primary completion30 May 2029 (estimated)
  4. Study completion30 Sep 2029 (estimated)

Resources

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
88 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07253129
Sponsor's protocol ID
T-START-PR
Acronym
T-START-PR
Status last verified
Dec 2025
First submitted
19 Nov 2025
Last updated
23 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Schmitz 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

  • 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 39270145

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 19 inclusion and 19 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 23 Dec 2025. 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-event-free survival (EFS) (time frame: up to 2 years for the 2y-EFS). 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 NCT07253129, 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 23 Dec 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in