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

NCT ID: NCT06149390

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

347 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-01

Study Completion Date

2023-07-01

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.

Conditions

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T-cell Lymphoma Adults

Keywords

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NHL T-cell lymphopma adults

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Consoliation with ASCT

consolidation therapy with first-line ASCT in PTCL patients who achieved CR after first-line treatment.

consolidation with ASCT

Intervention Type DRUG

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

non-ASCT

consolidation therapy without first-line ASCT in PTCL patients who achieved CR after first-line treatment.

No interventions assigned to this group

Interventions

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consolidation with ASCT

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

Intervention Type DRUG

Other Intervention Names

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consoliation therapy

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role collaborator

Ruijin Hospital

OTHER

Sponsor Role collaborator

West China Hospital

OTHER

Sponsor Role collaborator

Huazhong University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Liang Huang

Deputy Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaodong Mo

Role: PRINCIPAL_INVESTIGATOR

Peking University

Other Identifiers

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2023PHB202-001

Identifier Type: -

Identifier Source: org_study_id