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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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T-cell Lymphoma Adults

Intervention / Treatment
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* Drug: consolidation with ASCT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | death as a result of any cause | through study completion, an average of 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival | disease progression or death as a result of any cause | through study completion, an average of 2 year | 
| incidence of relapse rate | disease relapse | through study completion, an average of 2 year | 
| incidence of treatment related mortality rate | death without disease progression or relapse | through study completion, an average of 2 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NHL, T-cell lymphopma, adults