Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04747236
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2021-02-03
Brief Title:
Randomized Phase IIB Trial of Oral Azacytidine Plus Romidepsin Versus Investigators Choice in PTCL
Sponsor:
University of Virginia
Organization:
University of Virginia
Study Overview
Official Title:
A Randomized Phase IIB Multicenter Trial of Oral Azacytidine Plus Romidepsin Versus Investigators Choice in Patients With Relapse or Refractory Peripheral T-cell Lymphoma PTCL
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:
PTCL
Brief Summary:
The purpose of this study is to find out whether the combination treatment of romidepsin and oral azacytidine is safe and effective in patients with Peripheral T-Cell Lymphoma PTCL This study will compare the experimental combination treatment of romidepsin and oral azacytidine to single agent drugs already determined effective in patients with PTCL For the purposes of this study the single agent drugs already used to treat lymphoma are called investigators choice IC meaning the investigator will choose which one of these drugs to administer The IC drug options include romidepsin belinostat pralatrexate or gemcitabine given alone Funding Source FDA OOPD
Detailed Description:
Peripheral T-Cell Lymphoma PTCL is a rare and heterogeneous group of non-Hodgkin lymphoma NHL originating from mature or post-thymic or peripheral T- lymphocytes and NK cells They are considered very aggressive and are often resistant to conventional chemotherapy
This study employs a stratified randomization with equal allocation within strata of patients to receive oral 5-azacytidine AZA plus romidepsin ROMI versus pre-specified investigator choice ROMI belinostat pralatrexate or gemcitabine for the treatment of relapsed or refractory RR PTCL The dose and schedule of AZAROMI has been determined from a phase I clinical trial of the combination The primary objective of this study is to estimate the progression free survival PFS among patients receiving the combination compared to single agent of choice
This study employs a stratified randomization with equal allocation within strata of patients to receive oral 5-azacytidine AZA plus romidepsin ROMI versus pre-specified investigator choice ROMI belinostat pralatrexate or gemcitabine for the treatment of relapsed or refractory RR PTCL The dose and schedule of AZAROMI has been determined from a phase I clinical trial of the combination The primary objective of this study is to estimate the progression free survival PFS among patients receiving the combination compared to single agent of choice
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FD-R-006814-01 | OTHER_GRANT | Office of Orphan Products Development OOPD | None |