Ignite Creation Date:
2025-12-24 @ 12:18 PM
Ignite Modification Date:
2025-12-27 @ 10:06 PM
Study NCT ID:
NCT06393361
Status:
RECRUITING
Last Update Posted:
2024-08-26
First Post:
2024-04-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chidamide+Decitabine Plus Anti-PD-1 Antibody for Patients With R/R cHL Who Are Transplant-ineligible or Refused Transplant.
Sponsor:
Chinese PLA General Hospital
Organization:
Study Overview
Official Title:
A Randomized, Open-label, Phase 2 Trial of Chidamide+Decitabine Plus Anti- PD-1 Antibody for Patients With R/R cHL Who Are Transplant-ineligible or Refused Transplant
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
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:
The prognosis for patients with relapsed/refractory classical Hodgkin lymphoma (cHL) who refuse or are ineligible for transplant is poor. This open label, randomized, phase 2 study aims to evaluate the efficacy of Chidamide+Decitabine plus Anti-PD-1 Antibody and Brentuximab Vedotin plus Anti-PD-1 Antibody in transplant-ineligible or refused transplant diagnosedR/R cHL. The primary objective of the study is to evaluate progression-free survival.
Detailed Description:
The prognosis of refractory or early-relapsed lymphoma is poor, and it is even worse for those who are not eligible or refuse transplantation. Although many salvage regimens have been developed, there is no standard of care. Preliminary clinical observations have shown that Chidamide +Decitabine plus Anti-PD-1 Antibody might be beneficial for these patients. Brentuximab Vedotin plus Anti-PD-1 Antibody is a standard regimen . This open-label, randomized, phase 2 study aims to evaluate the efficacy of Chidamide+Decitabine plus anti-PD-1 antibody and Brentuximab Vedotin plus Anti-PD-1 Antibody, in patients with classical Hodgkin lymphoma who are transplant-ineligible or refused transplant . The primary objective of the study is to evaluate the progression free survival.The key secondary end points are complete response rate, objective response rate and the safety.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: