Allo-HSCT Vs. Auto-HSCT for PTCL Patients With PR After First-line Systemic Therapy : A Pr
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 tr
| Condition(s) | Peripheral T Cell Lymphoma |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | 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, w |
| Who can participate | Inclusion Criteria: 1. Age \& Sex: Males or females aged 18 to 70 years (inclusive). 2. ECOG performance status score of 0 to 1, with no deterioration within the last two weeks. 3. Expected survival period greater than 12 weeks. 4. Patients must have a histopathological confirmation of PTCL according to the 2016 revised WHO classification of lymphoid neoplasms (Swerdlow SH et al. 2016). Eligible histological subtypes are limited to the following: * Peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS) * Anaplastic large cell lymphoma, ALK-negative (ALK-ALCL) * Follicular helper T-cell lymphoma or PTCL with TFH phenotype (FTCL or PTCL-TFH) Patients undergoing allogeneic hematopoietic stem cell transplantation must have a suitable stem cell donor: (i) Related donors must be at least |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Lead sponsor | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine |
| Locations | Shanghai, Shanghai Municipality, China |
| Start date | 2025-12-31 |
| NCT ID | NCT07253129 |
| Official listing | https://clinicaltrials.gov/study/NCT07253129 |