T Cell Lymphoma -Stratified Therapy After Response to First-line Treatment-CR (T-START-CR)

This study is a multicenter, two-arm, prospective clinical trial, comprising two groups: the observation group and the autologous hematopoietic stem cell transplantation group (Auto-HSCT). It aims to evaluate the efficacy and safety of Auto-HSCT and observation in the treatment of peripheral T-cell lymphoma that has achieved complete response (CR) after first-line therapy. During the screening/baseline period, informed consent will be obtained, and inclusion/exclusion criteria will be verified. Group assignment (Observation vs. Auto-HSCT) will be determined taking into account the patient's preference. The study plans to enroll 80 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 Overview

• Status: Recruiting
• Conditions: Peripheral T Cell Lymphoma
• Intervention / Treatment: Procedure: Autologous Hematopoietic Stem Cell Transplantation; Other: Observation

• Study Type: Observational
• Enrollment (Estimated): 160

Contacts and Locations

• Study Contact: Name: xianmin song, MD; Phone Number: +862163240090; Email: shongxm@139.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200080
      • Recruiting
      • Shanghai General Hospital
      • Contact: xianmin Song, MD; Phone Number: 3172 86-21-63240090; Email: shongxm@sjtu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The patients with peripheral T-cell lymphoma that has achieved complete response (CR) after first-line therapy.

Description

Inclusion Criteria:

1. Age between 18 and 70 years (inclusive) at the time of signing the Informed Consent Form (ICF).
2. ECOG Performance Status score of 0 or 1, with no deterioration over the preceding two weeks.
3. Life expectancy of at least 12 weeks.

4. Histologically confirmed diagnosis of PTCL by the central study site according to the 2016 revised WHO classification of lymphoid neoplasms (Swerdlow SH et al. 2016). Eligible histological subtypes are restricted to the following:

   1. Peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS)
   2. Anaplastic large cell lymphoma, ALK-negative (ALK- ALCL)
   3. Follicular helper T-cell lymphoma or PTCL with a TFH phenotype (FTCL or PTCL-TFH)
5. Must have achieved a Complete Response (CR) as assessed per the Lugano 2014 classification criteria for lymphoma response after first-line systemic standard therapy (CHOP or a CHOP-like regimen).

6. Adequate hepatic and renal function, defined as:

   1. 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).
   2. Renal: Serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL/min as calculated by the Cockcroft-Gault formula or measured.
7. Left Ventricular Ejection Fraction (LVEF) ≥ 50% as measured by Multigated Acquisition (MUGA) scan or Echocardiography (ECHO).
8. 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.

Exclusion Criteria:

1.Ann Arbor Stage I disease. 2.History of any other malignancy within the past 5 years, except for locally curable malignancies that have been treated with curative intent (e.g., basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast).

3.Active infection, including:

1. Known active or latent tuberculosis, evidenced by a positive tuberculin (PPD) skin test (where a positive result is defined as an induration >10 mm or per local clinical standards) or findings suggestive of active/latent TB on chest X-ray/CT.
2. Known history of Human Immunodeficiency Virus (HIV) infection and/or AIDS.

3. Chronic active hepatitis B or C infection:

   1. For hepatitis B virus (HBV): Subjects who are HBV DNA positive are excluded. Subjects with undetectable HBV DNA levels are eligible. The upper limit of normal (ULN) for HBV DNA is determined by the local laboratory at each center.
   2. For hepatitis C virus (HCV): Subjects who are HCV RNA positive are excluded. Subjects with undetectable HCV RNA are eligible. The ULN for HCV RNA is determined by the local laboratory at each center.
4. Active viral infections other than hepatitis B or C (e.g., herpes zoster), or cytomegalovirus (CMV) infection.
5. Infection requiring intravenous antimicrobial therapy: evidenced by infection-related hemodynamic instability, worsening or new-onset infectious symptoms/signs, radiologic evidence of a new infectious focus, or persistent fever without localizing signs where infection cannot be ruled out.
6. Positive serological test for Epstein-Barr virus (EBV). 4.Poorly controlled cardiac symptoms or diseases, such as: i. 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.

5.Pregnant or lactating women, and subjects of childbearing potential unwilling to employ effective contraception.

6.Patients with psychiatric disorders or those unable to provide informed consent.

7.Any other condition which, in the investigator's judgment, makes the subject unsuitable for participation in this study

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Auto-HSCT; Auto-HSCT involves the infusion of the patient's own previously collected stem cells.	Procedure: Autologous Hematopoietic Stem Cell Transplantation; Auto-HSCT involves the infusion of the patient's own previously collected stem cells.
observation; This is a patient cohort that receives monitoring after first-line therapy with complete response.	Other: Observation; This is a patient cohort that receives monitoring after first-line therapy with complete response.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
event-free survival (EFS)	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 1 years for the 1y-CIR and up to 2 years for the 2y-CIR
Disease-Free Survival (DFS)	DFS means the time from transplantation until the first occurrence of any of the following events: disease recurrence, disease progression, or death from any cause.	up to 1 years for the DFS
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.	up to 1 years for the 1y-OS and up to 2 years for the 2y-OS

Collaborators and Investigators

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

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): January 20, 2026
• Primary Completion (Estimated): May 30, 2029
• Study Completion (Estimated): September 30, 2029

Study Registration Dates

• First Submitted: January 12, 2026
• First Submitted That Met QC Criteria: January 12, 2026
• First Posted (Actual): January 20, 2026

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: observation; complete response; autologous hematopoietic stem cell transplantation; Peripheral T Cell Lymphoma
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Disease Attributes; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Disease Progression; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Pathologic Complete Response; Lymphoma, T-Cell, Peripheral; Investigative Techniques; Methods; Observation
• Other Study ID Numbers: SHSYXYK-PTCL-CR-prospective

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No