Ignite Creation Date:
2024-07-17 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06486337
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-16
Brief Title:
CMOPR in the Treatment of Untreated Non-Hodgkins Lymphoma
Sponsor:
The First Affiliated Hospital of Soochow University
Organization:
The First Affiliated Hospital of Soochow University
Study Overview
Official Title:
A Single-arm Multi-center Prospective Clinical Study of Mitoxantrone Hydrochloride Liposome Injection-based CMOPR Regimen in the Treatment of Newly Diagnosed Non-Hodgkins Lymphoma
Status:
NOT_YET_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:
This is a prospective single arm multicenter study to evaluate the safety and efficacy of CMOPR in patients with newly diagnosed non-Hodgkins lymphoma
Detailed Description:
This is a single-arm open label multi-center clinical study to evaluate the safety and efficacy of mitoxantrone hydrochloride liposome in combination with Cyclophosphamide Vincristine Prednisone andor RituximabCMOPR in patients with newly diagnosed non-Hodgkins lymphoma Mitoxantrone hydrochloride liposome will be given on day 1 at dose of 18 mgm2 and be combined with cyclophosphamide vincristine prednisone andor Rituximab Each cycle consists of 28 days A maximum of 8 cycles6CMOPR2R of therapy are planned
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