Treatment choices after a complete response to first-line therapy for peripheral T‑cell lymphoma

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

This study will test whether autologous stem cell transplant or observation leads to better outcomes for people with peripheral T‑cell lymphoma who are in complete response after first‑line chemotherapy.

Quick facts

• Study type: Observational
• Enrollment: 160 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07353840 on ClinicalTrials.gov

What this trial studies

This prospective, two‑arm, multicenter cohort study compares outcomes for patients who undergo autologous hematopoietic stem cell transplantation (Auto‑HSCT) versus those managed with observation after achieving a complete response to first‑line CHOP or CHOP‑like therapy. Group assignment is determined with consideration of patient preference rather than randomization, and the protocol plans to enroll about 80 patients per arm. Baseline and follow‑up assessments include PET‑CT, bone marrow studies, flow cytometry, vital signs, and clinical exams to monitor disease status and safety. The study focuses on adults aged 18–70 with specific PTCL subtypes and ECOG 0–1 who have met Lugano 2014 criteria for complete response.

Who should consider this trial

Good fit: Adults aged 18–70 with histologically confirmed PTCL‑NOS, ALK‑ ALCL, or TFH‑phenotype PTCL who achieved a complete response after first‑line CHOP/CHOP‑like therapy, have ECOG 0–1, and adequate organ function are ideal candidates.

Not a fit: Patients who are not in complete response, have other PTCL subtypes, poor performance status, significant organ dysfunction, or cannot attend required visits in Shanghai are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the results could clarify which approach gives better long‑term disease control and help patients avoid unnecessary transplant‑related risks.

How similar studies have performed: Previous retrospective and some prospective reports have suggested Auto‑HSCT may improve progression‑free survival in selected PTCL patients, but randomized evidence is limited and conclusions are not definitive.

Eligibility criteria

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

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; autologous hematopoietic stem cell transplantation; observation; complete response