Ignite Creation Date:
2024-07-17 @ 10:48 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06489808
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-06-28
Brief Title:
Linperlisib Combined With Immunochemotherapy in RelapsedRefractory LBCL
Sponsor:
Institute of Hematology Blood Diseases Hospital China
Organization:
Institute of Hematology Blood Diseases Hospital China
Study Overview
Official Title:
An Open-label Multicenter Multi-cohort Clinical Study of Linperlisib Combined With Standard Immunochemotherapy in the Treatment of RelapsedRefractory Large B-Cell Lymphoma Failing to First-line Therapy
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:
To evaluate the efficacy and safety of Linperlisib combined with standard immunochemotherapy in patients with RR LBCL
Detailed Description:
This is a phase 2 open-label multicenter multi-cohort study evaluating the efficacy and safety of Linperlisib combined with standard immunochemotherapy in the treatment of relapsedrefractory LBCL after first-line treatment This study is divided into a safety run-in phase and a dose expansion phaseThe primary objective of the safety run-in phase was to determine the recommended dose for the dose expansion phase based on dose-limiting toxicities DLTs
The dose expansion phase consisted of Cohort 1 and Cohort 2Cohort 1 was transplant-ineligible patients who received Linperlisib in combination with R-Gemox at RP2D for 6 cyclesCohort 2 consisted of patients scheduled for transplantation who received 3 cycles of Linperlisib combined with R-ICEDHAPGVM regimen followed by autologous hematopoietic stem cell transplantation in responding patients
The dose expansion phase consisted of Cohort 1 and Cohort 2Cohort 1 was transplant-ineligible patients who received Linperlisib in combination with R-Gemox at RP2D for 6 cyclesCohort 2 consisted of patients scheduled for transplantation who received 3 cycles of Linperlisib combined with R-ICEDHAPGVM regimen followed by autologous hematopoietic stem cell transplantation in responding patients
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