ASCT Versus Chemotherapy as First-Line Consolidation Therapy inT-Cell Lymphoma

Sponsor

Huazhong University of Science and Technology (Other)

Overall Status

Completed

CT.gov ID

NCT06149390

Collaborator

Peking University People's Hospital (Other), Ruijin Hospital (Other), West China Hospital (Other)

347

Enrollment

113.9

Actual Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
T-cell Lymphoma Adults	Drug: consolidation with ASCT

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

347 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Jan 1, 2022

Actual Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Consoliation with ASCT consolidation therapy with first-line ASCT in PTCL patients who achieved CR after first-line treatment.	Drug: consolidation with ASCT high dose chemotherapy （BCNU, etoposide, cytarabine and melphalan)）and auto stem cells transfusion Other Names: consoliation therapy
non-ASCT consolidation therapy without first-line ASCT in PTCL patients who achieved CR after first-line treatment.

Arm

Intervention/Treatment

Consoliation with ASCT

consolidation therapy with first-line ASCT in PTCL patients who achieved CR after first-line treatment.

Drug: consolidation with ASCT

high dose chemotherapy （BCNU, etoposide, cytarabine and melphalan)）and auto stem cells transfusion

Other Names:

consoliation therapy

non-ASCT

consolidation therapy without first-line ASCT in PTCL patients who achieved CR after first-line treatment.

Outcome Measures

Primary Outcome Measures

overall survival [through study completion, an average of 2 year]
death as a result of any cause

Secondary Outcome Measures

progression-free survival [through study completion, an average of 2 year]
disease progression or death as a result of any cause
incidence of relapse rate [through study completion, an average of 2 year]
disease relapse
incidence of treatment related mortality rate [through study completion, an average of 2 year]
death without disease progression or relapse

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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