A Retrospective Clinical Study on the First-line Maintenance Treatment of PTCL With Chidamide.
Sponsor
The First Affiliated Hospital with Nanjing Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05967949
Collaborator
(none)
200
1
60
3.3
Study Details
Study Description
Brief Summary
The efficacy and safety of chidamide in first-line maintenance therapy for PTCL will be assessed through a retrospective case analysis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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.
Study Design
Study Type:
Observational
Anticipated Enrollment
:
200 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
A Retrospective (Non-interventional) Clinical Study on the First-line Maintenance Treatment of Peripheral T-cell Lymphoma (PTCL) With Chidamide.
Actual Study Start Date
:
Apr 1, 2023
Anticipated Primary Completion Date
:
Apr 1, 2026
Anticipated Study Completion Date
:
Apr 1, 2028
Outcome Measures
Primary Outcome Measures
- PFS [2 years]
progression free survival
Secondary Outcome Measures
- OS [2 years]
overall survival
- CR [2 years]
complete remission
- DOR [2 years]
duration of remission
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hematological Department, People's Hospital of Jiangsu Province | Nanjing | Jiangsu | China | 210029 |
Sponsors and Collaborators
- The First Affiliated Hospital with Nanjing Medical University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT05967949
Other Study ID Numbers:
- CS123
First Posted:
Aug 1, 2023
Last Update Posted:
Aug 1, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by The First Affiliated Hospital with Nanjing Medical University