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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06149390
Enrollment
347
Registered
2023-11-29
Start date
2014-01-01
Completion date
2023-07-01
Last updated
2023-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

T-cell Lymphoma Adults

Keywords

NHL, T-cell lymphopma, adults

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.

Interventions

DRUGconsolidation with ASCT

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

Sponsors

Peking University People's Hospital
CollaboratorOTHER
Ruijin Hospital
CollaboratorOTHER
West China Hospital
CollaboratorOTHER
Huazhong University of Science and Technology
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
overall survivalthrough study completion, an average of 2 yeardeath as a result of any cause

Secondary

MeasureTime frameDescription
progression-free survivalthrough study completion, an average of 2 yeardisease progression or death as a result of any cause
incidence of relapse ratethrough study completion, an average of 2 yeardisease relapse
incidence of treatment related mortality ratethrough study completion, an average of 2 yeardeath without disease progression or relapse

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026