Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06621199
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-29
Brief Title:
Mitoxantrone Hydrochloride Liposome in Combination With Cytarabine and Venetoclax Regimen in Newly Diagnosed Elderly AML
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Single-arm Multi-center Phase 2 Clinical Study of Mitoxantrone Hydrochloride Liposome in Combination With Cytarabine and Venetoclax Regimen in Newly Diagnosed Elderly AML
Status:
RECRUITING
Status Verified Date:
2024-07
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 phase 2 study to evaluate the efficacy and safety of mitoxantrone hydrochloride liposome in combination with cytarabine and venetoclax MAV regimen in newly diagnosed elderly AML To account conservatively for a 10 dropout rate before study completion we planned to include 42 patients The primary endpoint is 2-year event free survivalEFS
Detailed Description:
The optimal induction chemotherapy regimen for newly diagnosed elderly AML patients who are eligible for intense chemotherapy is currently not well defined Mitoxantrone hydrochloride liposome Lipo-MIT is an innovative anthracycline nano-drug which has been demonstrated favorable pharmacokinetic characteristics high cardiac safety and shown preliminary efficacy in adult AML Thus we designed a prospective single-arm phase 2 trial to explore the efficacy and safety of Lipo-MIT in combination with cytarabine and venetoclax MAV regimen in newly diagnosed elderly AML
The induction therapy is a combination of Lipo-MIT 24 mgm2 day 1 cytarabine100mgm2 day 1-5 and venetoclax 200mg day 2 300mg day 3 400mg day 4-10 and would be applied for two cycles Patients who achieve CRCRi after using MAV induction regimen will receive the consolidation therapy according to the patients cytogenetic-molecular risk stratification and maintenance therapy After completion of the treatment phase patients entered the follow-up period
The induction therapy is a combination of Lipo-MIT 24 mgm2 day 1 cytarabine100mgm2 day 1-5 and venetoclax 200mg day 2 300mg day 3 400mg day 4-10 and would be applied for two cycles Patients who achieve CRCRi after using MAV induction regimen will receive the consolidation therapy according to the patients cytogenetic-molecular risk stratification and maintenance therapy After completion of the treatment phase patients entered the follow-up period
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