Actively Recruiting
T Cell Lymphoma -Stratified Therapy After Response to First-line Treatment-CR
Led by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2026-01-20
160
Participants Needed
1
Research Sites
192 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
T Cell Lymphoma -Stratified Therapy After Response to First-line Treatment-CR
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years inclusive at the time of signing informed consent
- ECOG Performance Status score of 0 or 1, with no worsening in the past two weeks
- Life expectancy of at least 12 weeks
- Histologically confirmed peripheral T-cell lymphoma subtype: PTCL-NOS, ALK-negative ALCL, or FTCL/PTCL-TFH
- Complete response after first-line systemic therapy assessed by Lugano 2014 criteria
- Adequate liver function: total bilirubin ≤ 2 × ULN (or ≤ 3 × ULN with Gilbert's syndrome or liver involvement); ALT and AST ≤ 2.5 × ULN (or ≤ 5 × ULN with liver involvement)
- Adequate kidney function: serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min
- Left ventricular ejection fraction of 50% or higher by MUGA scan or echocardiography
- Voluntary participation with signed informed consent and ability to comply with study procedures
You will not qualify if you...
- Ann Arbor Stage I disease
- History of other malignancies in the past 5 years except certain locally curable cancers treated with curative intent
- Active infections including active or latent tuberculosis, HIV/AIDS, chronic active hepatitis B or C, other active viral infections, or infections requiring intravenous antimicrobial therapy
- Positive serological test for Epstein-Barr virus
- Poorly controlled heart conditions such as heart failure beyond NYHA Class II, unstable angina, recent myocardial infarction, or significant arrhythmias requiring treatment
- Pregnant or breastfeeding women, or unwillingness to use effective contraception if of childbearing potential
- Psychiatric disorders or inability to provide informed consent
- Any other condition judged by the investigator to make participation unsuitable
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shanghai General Hospital
Shanghai, Shanghai Municipality, China, 200080
Actively Recruiting
Research Team
X
xianmin song, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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