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

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

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.

Study Overview

• Status: Completed
• Conditions: T-cell Lymphoma Adults
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 347

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology
• Collaborators: Peking University People's Hospital; West China Hospital; Ruijin Hospital
• Investigators: Principal Investigator: Xiaodong Mo, Peking University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: November 17, 2023
• First Submitted That Met QC Criteria: November 25, 2023
• First Posted (Actual): November 29, 2023

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 25, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: NHL; adults; T-cell lymphopma
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral
• Other Study ID Numbers: 2023PHB202-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No