Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06421948
Status:
RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-05-06
Brief Title:
Linperlisib Combined With Chidamide in Patients With PTCL
Sponsor:
Yanyan Liu
Organization:
Henan Cancer Hospital
Study Overview
Official Title:
PI3Kδ Inhibitor Linperlisib Combined With HDAC Inhibitor Chidamide Versus CHOP in Patients With Peripheral T-cell Lymphoma a Multicenter Open Label Phase IbII Study
Status:
RECRUITING
Status Verified Date:
2024-05
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 goal of this clinical trial is to determine the maximum tolerated dose MTD of PI3Kδ inhibitor linperlisib when combined with fixed dose of HDAC inhibitor chidamide in participants with peripheral T-cell lymphoma PTCL and to compare the combination of linperlisib and chidamide to standard CHOP cyclophosphamide doxorubicinepirubicin vincristine and prednisone regimen chemotherapy in the frontline treatment of PTCL to see which therapy is better
Detailed Description:
In the phase Ib trial participants with newly diagnosed or relapsedrefractory PTCL will receive fixed dose of chidamide 20 mg twice a week and escalating dose of linperlisib 40 mg 60 mg or 80 mg once a day to find out the optimal dose of linperlisib
In the phase II trial participants with newly diagnosed PTCL will be randomized into experimental arm arm A to receive linperlisib in combination with chidamide or control arm arm B to receive standard CHOP regimen chemotherapy
Interim efficacy assessment will be performed after three cycles of treatment Responded participants will receive another three cycles of treatment After a total of 6 cycles of treatment participants can choose autologous hematopoietic stem cell transplantation maintenance treatment with linperlisib andor chidamide or watch and wait
In the phase II trial participants with newly diagnosed PTCL will be randomized into experimental arm arm A to receive linperlisib in combination with chidamide or control arm arm B to receive standard CHOP regimen chemotherapy
Interim efficacy assessment will be performed after three cycles of treatment Responded participants will receive another three cycles of treatment After a total of 6 cycles of treatment participants can choose autologous hematopoietic stem cell transplantation maintenance treatment with linperlisib andor chidamide or watch and wait
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?:
None