Clinical trial
Observational Clinical Study of Autologous Hematopoietic Stem Cell Transplantation and Chemotherapy as First-Line Consolidation Therapy After Obtaining a Complete Therapeutic Response in T-Cell Lymphoma
Name
2023PHB202-001
Description
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.
Trial arms
Trial start
2014-01-01
Estimated PCD
2022-01-01
Trial end
2023-07-01
Status
Completed
Treatment
consolidation with ASCT
high dose chemotherapy (BCNU, etoposide, cytarabine and melphalan))and auto stem cells transfusion
Arms:
Consoliation with ASCT
Other names:
consoliation therapy
Size
347
Primary endpoint
overall survival
through study completion, an average of 2 year
Eligibility criteria
Inclusion Criteria:
* Pathological diagnosis of T-cell lymphoma, including, but not limited to, Peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS), Angioimmunoblastic T-cell lymphoma (AITL) , ALK-negative anaplastic large cell lymphoma (ALCL, ALK-negative), Enteropathy-associated T-cell lymphoma (EATL), hepatosplenic T-cell lymphoma (HSTCL), and extranodal NK/T-cell lymphoma (ENKTL )
* 18-75 years old;
* Achievement of a complete response (CR) post-chemotherapy;
* Obtaining a complete response (CR) after chemotherapy;-Consistent follow-up visits post-treatment, with comprehensive follow-up data available;
Exclusion Criteria:
* Initially diagnosed with ALK-positive Anaplastic Large Cell Lymphoma (ALCL, ALK- - -CR was not achieved after treatment;
* Lack of complete follow-up information or lack of consent for follow-up and data collection
* T-cell lymphoma secondary to other malignancies
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 347, 'type': 'ACTUAL'}}
Updated at
2023-11-29
1 organization
1 product
1 indication
Organization
Huazhong University of Science and TechnologyProduct
Consolidation with ASCTIndication
T-cell lymphoma