ASCT Versus Chemotherapy as First-Line Consolidation Ther... | NCT06149390

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

NCT06149390

Sponsor

Huazhong University of Science and Technology

Status

Completed

Last Update Posted

Nov 29, 2023Actual

Enrollment

347Actual

Phase

Not provided

Conditions

T-cell Lymphoma Adults

Interventions

consolidation with ASCT

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2014Actual

Primary Completion Date

Jan 1, 2022Actual

Completion Date

Jul 1, 2023Actual

First Submitted Date

Nov 17, 2023

First Submission Date that Met QC Criteria

Nov 25, 2023

First Posted Date

Nov 29, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 25, 2023

Last Update Posted Date

Nov 29, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Liang Huang, Deputy Director, Huazhong University of Science and TechnologyPrincipal Investigator

Lead Sponsor

Huazhong University of Science and TechnologyOTHER

Collaborators

Name	Class
Peking University People's Hospital	OTHER
Ruijin Hospital	OTHER
West China Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

347Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
consolidation with ASCT	Drug	high dose chemotherapy （BCNU, etoposide, cytarabine and melphalan)）and auto stem cells transfusion	Consoliation with ASCT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
overall survival	death as a result of any cause	through study completion, an average of 2 year

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample