Ignite Creation Date:
2024-10-25 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06594640
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-05
Brief Title:
R-CMOP in Patients with Newly Diagnosed Diffuse Large B-cell Lymphoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter Prospective Phase III Trial to Evaluate the Safety and Efficacy of Mitoxantrone Hydrochloride Liposome in Combination with Cyclophosphamide Vincristine Prednisone and Rituximab in Patients with Newly Diagnosed DLBCL
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective clinical study to evaluate the safety and efficacy of R-CMOP in patients with newly diagnosed diffuse large B-cell lymphoma
Detailed Description:
This is an open multicenter prospective phase III clinical study to evaluate the safety and efficacy of mitoxantrone hydrochloride liposome injection in combination with cyclophosphamide vincristine prednisone and rituximab R-CMOP in patients with newly diagnosed diffuse large B-cell lymphoma The study is divided into two parts The first part uses a 33 dose-escalation design in which mitoxantrone hydrochloride liposome injection in the R-CMOP regimen will be administered at three different doses 16 mgm² 18 mgm² and 20 mgm² to determine the recommended Phase 2 dose RP2D The second part follows a single-arm design to evaluate the efficacy and safety of the R-CMOP regimen with mitoxantrone hydrochloride liposome injection administered at the RP2D Each cycle consists of 21 days A maximum of 6 cycles of therapy are planned
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None