Allogeneic versus Autologous Hematopoietic Stem Cell Transplant for Peripheral T‑Cell Lymphoma in Partial Response after First‑line Therapy

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 will test whether allogeneic or autologous stem cell transplant works better and is safer for adults with peripheral T‑cell lymphoma who have a partial response after first‑line treatment.

Quick facts

• Study type: Observational
• Enrollment: 88 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07253129 on ClinicalTrials.gov

What this trial studies

This is a prospective, multicenter two‑arm cohort comparing allogeneic (Allo‑HSCT) and autologous (Auto‑HSCT) hematopoietic stem cell transplantation in PTCL patients who achieved a partial response after first‑line therapy. Group assignment is based on matched donor availability and patient preference, with a planned cohort of 44 patients undergoing allogeneic transplant and concurrent autologous cases included for comparative analysis. Outcomes will include measures of efficacy (relapse, progression‑free and overall survival) and safety (treatment‑related mortality and complications), analyzed using inverse probability weighting to account for nonrandom group assignment. The protocol requires standard transplant eligibility criteria, donor HLA‑matching thresholds for allo‑HSCT, and baseline performance status and survival expectations.

Who should consider this trial

Good fit: Adults aged 18–70 with histologically confirmed PTCL subtypes (PTCL‑NOS, ALK‑negative ALCL, or TFH‑phenotype) who are in partial response after first‑line systemic therapy, have ECOG 0–1, and either have an adequate matched donor for allo‑HSCT or are eligible for auto‑HSCT.

Not a fit: Patients with other lymphoma subtypes, those not in partial response after first‑line therapy, those with ECOG >1 or major comorbidities that make transplant unsafe, or those unable/unwilling to undergo transplantation are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the results could help clinicians choose the transplant type that offers better long‑term control with acceptable safety for PTCL patients in partial response.

How similar studies have performed: Prior cohort and registry data suggest allo‑HSCT may reduce relapse risk but increases treatment‑related mortality compared with auto‑HSCT, and direct prospective head‑to‑head comparisons are still limited.

Eligibility criteria

Inclusion Criteria:

1. Age \& Sex:

   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:

1. Ann Arbor clinical stage I disease.
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.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai General Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: xianmin song, MD

Conditions Peripheral T Cell Lymphoma; peripheral T cell lymphoma; allogeneic hematopoietic stem cell transplantation; autologous hematopoietic stem cell transplantation; partial response