Ignite Creation Date:
2025-12-26 @ 10:43 PM
Ignite Modification Date:
2025-12-26 @ 10:43 PM
Study NCT ID:
NCT03558412
Status:
UNKNOWN
Last Update Posted:
2018-09-14
First Post:
2018-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Trial of Decitabine in Relapsed or Refractory T-lymphoblastic Lymphoma
Sponsor:
Mingzhi Zhang
Organization:
Study Overview
Official Title:
A Clinical Trial of Decitabine Combined With CODOX-M/IVAC in Relapsed or Refractory T-lymphoblastic Lymphoma
Status:
UNKNOWN
Status Verified Date:
2018-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To explore the safety, tolerability, and clinical effects of decitabine combined with Second-line chemotherapy regimens for patients with relapsed or refractory T-lymphoblastic lymphoma.
Detailed Description:
This is a prospective, open，investigator initial clinical trial with a single arm, aimed to evaluate the safety, tolerability, and efficacy of decitabine combined with Second-line chemotherapy regimens (CODOX-M/IVAC) in relapsed or refractory T-lymphoblastic lymphoma. A total of 40 patients are planned to be enrolled into the study. Patients with diagnosis of relapsed or refractory T-lymphoblastic lymphoma will be treated with decitabine plus CODOX-M/IVAC. The primary end point is responder rate (RR) and time to progression (TTP), and the secondary end points include overall survival (OS) and the median survival time (MST).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: