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

NCT06149390 | Completed DMC FDA Drug

• 1 other identifier: 2023PHB202-001
• Study Type: observational
• Target: 347
• Locations: 0 countries
• Sites: N/A

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.

Conditions

T-cell Lymphoma Adults

Keywords

NHL; T-cell lymphopma; adults

Outcome Measures

Primary Outcomes (1)

• overall survival

  death as a result of any cause

  through study completion, an average of 2 year

Secondary Outcomes (3)

• progression-free survival

  through study completion, an average of 2 year

• incidence of relapse rate

  through study completion, an average of 2 year

• incidence of treatment related mortality rate

  through study completion, an average of 2 year

Study Arms (2)

Consoliation with ASCT

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

Drug: consolidation with ASCT

non-ASCT

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

Interventions

consolidation with ASCT DRUG

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

Also known as: consoliation therapy

Consoliation with ASCT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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 )
• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead
• Peking University People's Hospital: collaborator
• Ruijin Hospital: collaborator
• West China Hospital: collaborator

Study Officials

• Xiaodong Mo

  Peking University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: November 29, 2023
• Study Start: January 1, 2014
• Primary Completion: January 1, 2022
• Study Completion: July 1, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11