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

T-cell Lymphoma Adults Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06149390
• Other study ID #: 2023PHB202-001
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• T-cell Lymphoma Adults

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