A Retrospective Clinical Study on the First-line Maintena... | NCT05967949

Studies
A Retrospective Clinical Study on the First-line Maintenance Treatment of PTCL With Chidamide.

NCT05967949

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Status

Recruiting

Last Update Posted

Aug 1, 2023Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

PTCL

Interventions

chidamide

Countries

China

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

Jul 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2023Actual

Primary Completion Date

Apr 1, 2026Estimated

Completion Date

Apr 1, 2028Estimated

First Submitted Date

Jul 23, 2023

First Submission Date that Met QC Criteria

Jul 23, 2023

First Posted Date

Aug 1, 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

Jul 23, 2023

Last Update Posted Date

Aug 1, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The efficacy and safety of chidamide in first-line maintenance therapy for PTCL will be assessed through a retrospective case analysis.

Detailed Description

The study design belongs to a retrospective study, collecting information on patients with PTCL who were diagnosed and treated with chidamide as maintenance therapy at our center. The collected data includes age, gender, previous treatment regimens, results of auxiliary examinations (such as blood routine, biochemistry, bone marrow cytology, pathology, flow cytometry, NGS, etc.), as well as PET-CT images. The safety and efficacy of Chidemide as first-line maintenance therapy in PTCL will be analyzed.

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

200Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
chidamide	Drug	This subset of patients received chidamide as first-line maintenance therapy.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PFS	progression free survival	2 years

Secondary Outcomes

Measure	Description	Time Frame
OS	overall survival	2 years
CR	complete remission	2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

(1) Age: 18 years and older; (2) Gender: Male/Female; (3) Diagnosed with PTCL; (4) Received chidamide as maintenance therapy after first-line treatment.

Exclusion Criteria:

(1) Patients with other types of lymphomas; (2) Pregnant women.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adults diagnosed with PTCL, who have undergone first-line treatment and are using chidemide as maintenance therapy.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
wei xu	Contact	+862568302182		xuwei10000@hotmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hematological Department, People's Hospital of Jiangsu Province	Recruiting	Nanjing	Jiangsu	210029	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C547816	N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided