NCT05967949

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
23mo left

Started Apr 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
Apr 2023Apr 2028

Study Start

First participant enrolled

April 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Expected
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

3 years

First QC Date

July 23, 2023

Last Update Submit

July 23, 2023

Conditions

PTCL

Keywords

chidamidemaintenance treatment

Outcome Measures

Primary Outcomes (1)

  • PFS

    progression free survival

    2 years

Secondary Outcomes (3)

  • OS

    2 years

  • CR

    2 years

  • DOR

    2 years

Interventions

chidamideDRUG

This subset of patients received chidamide as first-line maintenance therapy.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hematological Department, People's Hospital of Jiangsu Province

Nanjing, Jiangsu, 210029, China

RECRUITING

MeSH Terms

Interventions

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

Central Study Contacts

wei xu

CONTACT

+862568302182xuwei10000@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2023

First Posted

August 1, 2023

Study Start

April 1, 2023

Primary Completion

April 1, 2026

Study Completion (Estimated)

April 1, 2028

Last Updated

August 1, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)