A randomized phase 3 trial of autologous vs allogeneic transplantation as part of first-line therapy in poor-risk peripheral T-NHL.
Norbert Schmitz, Lorenz Truemper, Krimo Bouabdallah...
https://pubmed.ncbi.nlm.nih.gov/33512419Actively Recruiting
Age: 18Years - 70Years
All Genders
ID07253129
Allogeneic Versus Autologous Hematopoietic Stem Cell Transplantation for Peripheral T-cell Lymphoma Patients With Partial Remission After First-line Therapy: A Prospective Multicenter Cohort Study
Led by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2025-12-23
88
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two types of hematopoietic stem cell transplantation—autologous (Auto-HSCT) and allogeneic (Allo-HSCT)—for patients with peripheral T-cell lymphoma (PTCL) who have achieved a partial response after first-line systemic therapy. This multicenter, prospective clinical trial aims to compare the effectiveness and safety of these treatments in this patient population, with a focus on event-free survival and other clinical outcomes. The study enrolls adults aged 18 to 70 years who meet specific health and disease criteria. Participants are assigned to one of two groups based on donor availability and personal preference: the Allo-HSCT group receives stem cells from a compatible donor, while the Auto-HSCT group receives their own previously collected stem cells. Both procedures involve infusion of stem cells following chemotherapy, and the study includes detailed assessments to monitor patient response and safety. Enrollment includes 44 patients in the Allo-HSCT group and concurrent patients in the Auto-HSCT group for comparative analysis. During the study, participants undergo thorough screening including medical history, physical exams, vital signs, PET-CT scans, bone marrow tests, and laboratory evaluations. Researchers will monitor event-free survival over two years and assess other outcomes such as complete response rates at three and six months, relapse rates, overall survival, and non-relapse mortality. The study lasts for several years, with regular follow-up to ensure safety and collect data on treatment effects.
CONDITIONS
Brief 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
Age: 18Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
- Males or females aged 18 to 70 years (inclusive)
- ECOG performance status score of 0 to 1 without worsening in the last two weeks
- Expected survival period greater than 12 weeks
- Histopathological confirmation of PTCL according to 2016 WHO classification, including PTCL-NOS, ALK-negative ALCL, or follicular helper T-cell lymphoma/PTCL with TFH phenotype
- Suitable stem cell donor availability for allogeneic transplantation (related donors at least 5/10 matched; unrelated donors at least 8/10 matched)
- Partial response after six cycles of CHOP, BV-CHP, or CHOP-like chemotherapy per Lugano 2014 criteria
- Hematopoietic Cell Transplantation-Comorbidity Index score ≤ 2
- Adequate liver, kidney, heart, and lung function as defined by specific laboratory and clinical criteria
You will not qualify if you...
- Ann Arbor clinical stage I disease
- History of malignancy within past 5 years except certain locally curable cancers
- Active infections including tuberculosis, HIV/AIDS, active hepatitis B or C, other viral infections, or infections requiring intravenous antimicrobial therapy
- Positive serum DNA test for Epstein-Barr virus
- Poorly controlled cardiac conditions such as heart failure > NYHA class II, unstable angina, recent myocardial infarction, or significant arrhythmias needing treatment
- Pregnant or breastfeeding women or those unwilling to use contraception
- Psychiatric illness or inability to provide informed consent
- PTCL with central nervous system involvement
- Previous treatment with PD-1 inhibitors
- Any condition making participation unsuitable per investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - Up to 2 years
Participants who undergo allo-HSCT or auto-HSCT are observed to evaluate outcomes after their respective stem cell transplantation procedures.
Regular visits according to clinical care for up to 2 years
Trial Site Locations
Total: 1 location
1
Shanghai General Hospital
Shanghai, Shanghai Municipality, China, 200080
Actively Recruiting
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Research Team
X
xianmin song, MD
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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Published Research Related To This Trial
Long-Term Follow-Up of the Prospective Randomized AATT Study (Autologous or Allogeneic Transplantation in Patients With Peripheral T-Cell Lymphoma).
Olivier Tournilhac, Bettina Altmann, Birte Friedrichs...
https://pubmed.ncbi.nlm.nih.gov/39270145