Actively Recruiting
T Cell Lymphoma -Stratified Therapy After Response to First-line Treatment-NR
Led by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2026-03-13
58
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
S
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor
X
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is a multicenter, two-arm, prospective clinical trial, comprising two groups: the allogeneic hematopoietic stem cell transplantation group (Allo-HSCT) and the alternative salvage regimens. It aims to evaluate the efficacy and safety of Allo-HSCT and alternative salvage regimens in the treatment of peripheral T-cell lymphoma that has achieved no response (NR) after first-line therapy. During the screening/baseline period, informed consent will be obtained, and inclusion/exclusion criteria will be verified. Group assignment (Allo-HSCT vs. alternative salvage regimens) will be determined taking into account the availability of a matched donor and the patient's preference. The study plans to enroll 29 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-NR
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 70 years at the time of consent
- Have stable or progressive peripheral T-cell lymphoma after first-line chemotherapy (CHOP or similar), including no response after at least 4 cycles or disease progression during treatment
- Histologically confirmed diagnosis of specific PTCL subtypes: PTCL-NOS, ALK-negative ALCL, or TFH phenotype lymphoma
- Suitable stem cell donor available if planned for allogeneic stem cell transplantation, meeting specific HLA matching criteria
- Hematopoietic Cell Transplantation-Specific Comorbidity Index (HCT-CI) score of 2 or less
- ECOG Performance Status score of 0 or 1, stable for the past two weeks
- Life expectancy of at least 12 weeks
- Adequate liver, kidney, heart, lung functions as specified in protocol
- Willingness and ability to participate and comply with study procedures with signed informed consent
You will not qualify if you...
- Ann Arbor Stage I disease
- History of other malignancies within 5 years except certain cured skin or superficial cancers
- Active infections including active or latent tuberculosis, HIV/AIDS, active hepatitis B or C, active viral infections, or infections requiring intravenous antibiotics
- Positive serum DNA test for Epstein-Barr virus
- Poorly controlled heart conditions such as NYHA Class greater than II heart failure, unstable angina, recent myocardial infarction, or significant arrhythmias
- Pregnant or breastfeeding women or unwillingness to use effective contraception if of childbearing potential
- Psychiatric disorders or inability to provide informed consent
- PTCL involving the central nervous system
- Prior treatment with PD-1/PD-L1 inhibitors
- Any other condition deemed unsuitable by the investigator for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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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