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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.


Recruitment information / eligibility

Status Completed
Enrollment 347
Est. completion date July 1, 2023
Est. primary completion date January 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Intervention

Drug:
consolidation with ASCT
high dose chemotherapy (BCNU, etoposide, cytarabine and melphalan))and auto stem cells transfusion

Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
Huazhong University of Science and Technology Peking University People's Hospital, Ruijin Hospital, West China Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary overall survival death as a result of any cause through study completion, an average of 2 year
Secondary progression-free survival disease progression or death as a result of any cause through study completion, an average of 2 year
Secondary incidence of relapse rate disease relapse through study completion, an average of 2 year
Secondary incidence of treatment related mortality rate death without disease progression or relapse through study completion, an average of 2 year
See also
  Status Clinical Trial Phase
Recruiting NCT01788137 - A Study of Improving the Efficacy of Treatment in High Risk T Cell Lymphoma Patients Phase 3
Enrolling by invitation NCT03207789 - T-cell Brazil: Prospective Collection of Data in T-cell Lymphomas Patients N/A