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T Cell Lymphoma -Stratified Therapy After Response to First-line Treatment-CR | Clinical Trials | Clareo Health

RECRUITING

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

NCT07353840•Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Summary

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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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).
+3 more criteria

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.
+3 more criteria

Locations (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

January 20, 2026

Primary Completion Date

May 30, 2029

Completion Date

September 30, 2029

Last Updated

January 20, 2026

Enrollment

160

ESTIMATED participants

Conditions

Peripheral T Cell Lymphoma

Interventions

Autologous Hematopoietic Stem Cell Transplantation

PROCEDURE

Observation

OTHER

Contacts

xianmin song, MD

CONTACT

+862163240090 shongxm@139.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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