Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06149390 |
Other study ID # |
2023PHB202-001 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
January 1, 2014 |
Est. completion date |
July 1, 2023 |
Study information
Verified date |
November 2023 |
Source |
Huazhong University of Science and Technology |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
To compare the effectiveness of autologous hematopoietic stem cell transplantation and
chemotherapy as first-line consolidation therapy after obtaining a complete therapeutic
response in T-cell lymphoma through a multicenter retrospective real-world study in China.
Description:
T-cell lymphoma is characterized by high molecular heterogeneity, high disease
aggressiveness, and high chemotherapy resistance rate, and the prognosis is extremely poor.
Autologous hematopoietic stem cell transplantation (ASCT) is an important consolidation
therapy for patients with T-cell lymphoma who have achieved therapeutic response to
chemotherapy, but it is still controversial whether the efficacy of ASCT is significantly
better than that of chemotherapy consolidation in patients who have achieved a complete
therapeutic response. In this study, the investigators compared the efficacy of ASCT with
that of chemotherapy as a first-line consolidation therapy for T-cell lymphoma patients who
had achieved a complete therapeutic response in a multicenter real-world study in China. This
study included patients with primary T-cell lymphoma diagnosed during 2015-2021 at Shanghai
Ruijin Hospital, Peking University People's Hospital, and Wuhan Tongji Hospital, and based on
electronic case information, the investigators retrieved the diagnosis, staging, extranodal
and bone marrow involvement, and induced and consolidated the efficacy of chemotherapy. The
participants were divided into ASCT group and consolidation chemotherapy group according to
the consolidation therapy adopted after obtaining complete therapeutic response, and the
primary endpoint was adopted as progression-free survival, and the secondary endpoints
included overall survival, non-recurrent death, and disease progression/recurrence, so as to
explore the efficacy of ASCT and chemotherapy as a first-line consolidation therapy after
obtaining a complete therapeutic response in T-cell lymphoma.