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

NCT07253129 | Recruiting

• 1 other identifier: T-START-PR
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Peripheral T Cell Lymphoma

Keywords

peripheral T cell lymphoma; allogeneic hematopoietic stem cell transplantation; autologous hematopoietic stem cell transplantation; partial response

Outcome Measures

Primary Outcomes (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.

  up to 2 years for the 2y-EFS

Secondary Outcomes (4)

• 3m and 6m-complete response rate

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

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

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

• 1y and 2y-overall survival (OS)

  up to 1 years for the 1y-OS and up to 2 years for the 2y-OS

• non-relapse mortality (NRM)

  up to 1 years

Study Arms (2)

Allo-HSCT

Allo-HSCT involves the infusion of stem cells collected from a donor (genetically similar, but not identical)

Procedure: Allogenic stem cell transplant (ASCT)

Auto-HSCT

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

Procedure: Autologous Hematopoietic Stem Cell Transplantation

Interventions

Autologous Hematopoietic Stem Cell Transplantation PROCEDURE

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

Also known as: Auto-HSCT

Auto-HSCT

Allogenic stem cell transplant (ASCT) PROCEDURE

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

Also known as: ASCT, Allo-HSCT

Allo-HSCT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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)
• 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:
• (i) Related donors must be at least 5/10 matched for HLA-A, -B, -C, -DQB1, and -DRB1.
• (ii) 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).

You may not qualify if:

• 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:
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• 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.
• (d) Active viral infections other than hepatitis B or hepatitis C (e.g., herpes zoster, cytomegalovirus).
• (e) 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.
• (f) Positive serum DNA test for Epstein-Barr virus (EBV).
• Poorly controlled cardiac symptoms or disease, such as:
• i. 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.

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 33512419 BACKGROUND

• 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.

  PMID: 39270145 BACKGROUND

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

xianmin song, MD

CONTACT

+862163240090; shongxm@139.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 28, 2025
• Study Start: December 31, 2025
• Primary Completion (Estimated): May 30, 2029
• Study Completion (Estimated): September 30, 2029
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)