Treatment options for peripheral T‑cell lymphoma after no response to first‑line therapy

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

This project will try allogeneic stem cell transplant versus other salvage treatments for adults with peripheral T‑cell lymphoma who did not respond to first‑line chemotherapy.

Quick facts

• Study type: Observational
• Enrollment: 58 (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: NCT07470996 on ClinicalTrials.gov

What this trial studies

This is a prospective, non‑randomized, two‑arm observational study comparing allogeneic hematopoietic stem cell transplantation (Allo‑HSCT) with alternative salvage regimens in patients with peripheral T‑cell lymphoma who have stable or progressive disease after first‑line CHOP or CHOP‑like therapy. Group assignment is based on matched donor availability and patient preference rather than randomization, with a planned enrollment of 29 patients per arm. Baseline and follow‑up data include demographics, medical history, vital signs, physical exams, PET‑CT, bone marrow aspiration/biopsy with flow cytometry and pathology, and safety monitoring. The study is conducted at Shanghai General Hospital with participating Shanghai university hospitals collaborating on enrollment and assessments.

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 have stable disease or progressive disease after at least four cycles of CHOP or a CHOP‑like regimen are the intended participants.

Not a fit: Patients who achieved a response to first‑line therapy, who have PTCL subtypes outside the listed eligibility, who are medically unfit for transplantation or intensive salvage therapy, or who cannot access the treating center are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the study could clarify whether allogeneic transplant or alternative salvage regimens offer better disease control and survival for patients with peripheral T‑cell lymphoma who fail first‑line therapy.

How similar studies have performed: Allo‑HSCT has shown benefit for some patients with relapsed or refractory PTCL in retrospective and single‑arm prospective series, but randomized evidence comparing transplant to alternative salvage regimens is limited.

Eligibility criteria

Inclusion Criteria:

1. At the time of ICF signing, the subject must be 18-70 years of age, inclusive, regardless of gender.
2. The subject must have achieved Stable Disease (SD) or Progressive Disease (PD) as assessed per the Lugano 2014 classification criteria after first-line systemic standard therapy (CHOP or a CHOP-like regimen). This includes subjects who failed to achieve a response after at least 4 cycles of standard chemotherapy or who experienced disease progression during treatment.
3. The subject must have a histologically confirmed diagnosis of PTCL according to the 2016 revised WHO classification of lymphoid neoplasms (Swerdlow SH et al. 2016). Eligible histological subtypes are restricted to the following: Not Otherwise Specified (PTCL-NOS); ALK-negative Anaplastic Large Cell Lymphoma (ALK- ALCL); Follicular Helper T-cell Lymphoma or PTCL with a TFH phenotype (FTCL or PTCL-TFH). Additionally, they must meet the following condition:

   Patients scheduled for allogeneic hematopoietic stem cell transplantation must have a suitable stem cell donor:

   i. Related donors must be at least 5/10 matched at HLA-A, -B, -C, -DQB1, and -DRB1.

   ii. Unrelated donors must be at least 8/10 matched at HLA-A, -B, -C, -DQB1, and -DRB1.
4. Hematopoietic Cell Transplantation-Specific Comorbidity Index (HCT-CI) score ≤ 2.
5. ECOG Performance Status score of 0 or 1, with no deterioration over the preceding two weeks.
6. Life expectancy of at least 12 weeks.
7. Adequate hepatic, renal, cardiac, and pulmonary function, defined as:

   i. 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).

   ii. Renal: Serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL/min as calculated by the Cockcroft-Gault formula or measured.

   iii. Cardiac: Left Ventricular Ejection Fraction (LVEF) ≥ 50% as measured by Multigated Acquisition (MUGA) scan or Echocardiography (ECHO).

   iv. Baseline oxygen saturation on room air \> 92%. v. Pulmonary: Diffusing capacity of the lungs for carbon monoxide (DLCO), corrected for hemoglobin, ≥ 40% and Forced Expiratory Volume in 1 second (FEV1) ≥ 50% of predicted.
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 cured malignancies after radical therapy (e.g., basal cell or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast).
3. Active infection, including:

   * Known active or latent tuberculosis, indicated by a positive tuberculin (PPD) skin test (defined as induration \>10 mm or per local clinical criteria) or radiographic findings on chest X-ray/CT suggestive of active/latent TB.

     * Known history of Human Immunodeficiency Virus (HIV) infection and/or Acquired Immunodeficiency Syndrome (AIDS).

       * Chronic active hepatitis B or C infection:

         1. Hepatitis B virus (HBV) DNA-positive subjects are excluded; those with undetectable HBV-DNA are eligible. The upper limit of normal (ULN) for HBV-DNA is as defined by each participating center.
         2. Hepatitis C virus (HCV) RNA-positive subjects are excluded; those with undetectable HCV-RNA are eligible. The ULN for HCV-RNA is as defined by each participating center.

            * Active viral infections other than hepatitis B or C (e.g., herpes zoster, cytomegalovirus).

              * Infection requiring intravenous antimicrobial therapy, evidenced by: hemodynamic instability related to infection, worsening or new infectious symptoms/signs, new infectious foci on imaging, or persistent fever without localizing signs where infection cannot be ruled out.

                * Positive serum DNA test for Epstein-Barr virus (EBV).
4. Poorly controlled cardiac symptoms or diseases, including:

   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 use effective contraception.
6. Patients with psychiatric disorders or those unable to provide informed consent.
7. PTCL patients with central nervous system involvement.
8. PTCL patients who have received prior PD-1/PD-L1 inhibitor therapy.
9. Any other condition that, in the investigator's judgment, renders the subject unsuitable for study participation.

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; no response; allogeneic hematopoietic stem cell transplantation; alternative salvage regimens