Allo-HSCT Vs. Auto-HSCT for PTCL Patients With PR After First-line Systemic Therapy : A Prospective, Multicenter, Cohort Study-(T-START-PR)
NCT ID: NCT07253129
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
88 participants
OBSERVATIONAL
2025-12-31
2029-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Allo-HSCT
Allo-HSCT involves the infusion of stem cells collected from a donor (genetically similar, but not identical)
Allogenic stem cell transplant (ASCT)
ASCT involves the infusion of stem cells collected from a donor (genetically similar, but not identical).
Auto-HSCT
Auto-HSCT involves the infusion of the patient's own previously collected stem cells.
Autologous Hematopoietic Stem Cell Transplantation
Auto-HSCT involves the infusion of the patient's own previously collected stem cells.
Interventions
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Autologous Hematopoietic Stem Cell Transplantation
Auto-HSCT involves the infusion of the patient's own previously collected stem cells.
Allogenic stem cell transplant (ASCT)
ASCT involves the infusion of stem cells collected from a donor (genetically similar, but not identical).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Males or females aged 18 to 70 years (inclusive).
2. ECOG performance status score of 0 to 1, with no deterioration within the last two weeks.
3. Expected survival period greater than 12 weeks.
4. 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.
5. 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.
6. Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) score ≤ 2.
7. Adequate hepatic, renal, cardiac, and pulmonary function, defined as follows:
1. 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).
2. Renal function: Serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL/min as calculated or measured by the Cockcroft-Gault method.
3. Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50% as measured by multigated acquisition (MUGA) scan or echocardiography (ECHO).
4. Baseline oxygen saturation \> 92%.
5. Pulmonary function: Diffusing capacity of the lung for carbon monoxide (DLCO) (hemoglobin-corrected) ≥ 40% and forced expiratory volume in 1 second (FEV1) ≥ 50%.
Exclusion Criteria
2. 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).
3. Active infection, including:
1. 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.
2. Known history of infection with Human Immunodeficiency Virus (HIV) and/or AIDS.
3. Chronic active hepatitis B or hepatitis C infection:
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1. 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.
2. 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).
4. 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.
5. Pregnant or lactating women, and subjects of childbearing potential unwilling to use effective contraception.
6. Psychiatric illness or individuals unable to provide informed consent.
7. PTCL patients with central nervous system involvement.
8. PTCL patients who have previously received PD-1 inhibitor therapy.
9. Any other condition that, in the judgment of the investigator, would make the subject unsuitable for participation in this study.
18 Years
70 Years
ALL
No
Sponsors
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Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Xianmin Song, MD
Professor
Locations
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Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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xianmin Song, MD
Role: primary
References
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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.
Other Identifiers
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T-START-PR
Identifier Type: -
Identifier Source: org_study_id