Clinical trial NCT06149390: ASCT Versus Chemotherapy as First-Line Consolidation Therapy inT-Cell Lymphoma
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: T-cell Lymphoma Adults
Keywords: NHL
T-cell lymphopma
adults
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Peking University People's Hospital
name: Ruijin Hospital
name: West China Hospital
First posted: 2023-11-29
Enrollment: 347
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A preliminary count of approximately 80 patients who received ASCT autologous transplantation and 250 patients who received chemotherapy was conducted as a retrospective cohort study, and all eligible patients were proposed to be included in this study.

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.

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.

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

Primary outcomes:
measure: overall survival
timeFrame: through study completion, an average of 2 year
Secondary outcomes:
measure: progression-free survival
timeFrame: through study completion, an average of 2 year
measure: incidence of relapse rate
timeFrame: through study completion, an average of 2 year
measure: incidence of treatment related mortality rate
timeFrame: through study completion, an average of 2 year
Other outcomes:
Locations:
Study officials:
affiliation: Peking University
name: Xiaodong Mo
role: PRINCIPAL_INVESTIGATOR
References: