Actively Recruiting
Allo-HSCT Vs. Auto-HSCT for PTCL Patients With PR After First-line Systemic Therapy : A Prospective, Multicenter, Cohort Study-(T-START-PR)
Led by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2025-12-23
88
Participants Needed
1
Research Sites
195 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 allogeneic hematopoietic stem cell transplantation group (Allo-HSCT) and the autologous hematopoietic stem cell transplantation group (Auto-HSCT). It aims to evaluate the efficacy and safety of Auto-HSCT and Allo-HSCT in the treatment of peripheral T-cell lymphoma that has achieved partial response (PR) 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. Auto-HSCT) will be determined taking into account the availability of a matched donor and the patient's preference. The study plans to enroll 44 patients in the allogeneic hematopoietic stem cell transplantation group, while all concurrent patients undergoing autologous stem cell transplantation will be included in the other group for inverse probability weighting analysis. 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
Allo-HSCT Vs. Auto-HSCT for PTCL Patients With PR After First-line Systemic Therapy : A Prospective, Multicenter, Cohort Study-(T-START-PR)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 70 years
- ECOG performance status score of 0 to 1 with no recent worsening
- Expected survival period longer than 12 weeks
- Histopathological confirmation of PTCL with eligible subtypes: PTCL-NOS, ALK-negative ALCL, or FTCL/PTCL-TFH
- Suitable stem cell donor available for allogeneic transplantation (related donors at least 5/10 HLA match; unrelated donors at least 8/10 HLA match)
- Partial response after six cycles of CHOP, BV-CHP, or CHOP-like chemotherapy
- Hematopoietic Cell Transplantation-Comorbidity Index score of 2 or less
- Adequate liver, kidney, heart, and lung function as defined by specific laboratory and clinical measurements
You will not qualify if you...
- Ann Arbor clinical stage I disease
- History of malignancy within the past 5 years except certain locally curable cancers
- Active infections including active or latent tuberculosis, HIV/AIDS, chronic active hepatitis B or C, other active viral infections, or infections requiring intravenous antibiotics with serious symptoms
- Positive serum DNA test for Epstein-Barr virus
- Poorly controlled cardiac conditions such as severe 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 illness or inability to provide informed consent
- PTCL with central nervous system involvement
- Previous treatment with PD-1 inhibitors
- Any other condition judged by the investigator to make participation unsuitable
AI-Screening
AI-Powered 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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