Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06621212
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-29
Brief Title:
Mitoxantrone Hydrochloride Liposome Standard-dose of Cytarabine and Venetoclax in the Treatment of RR AML
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Single-center Exploratory Study of Mitoxantrone Hydrochloride Liposome Injection Combined With Standard-dose Cytarabine and Venetoclax in the Treatment of RelapsedRefractory Acute Myeloid Leukemia
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:
The purpose of this prospective single-center single-arm exploratory study is to evaluate the efficacy and safety of a combination regimen of mitoxantrone hydrochloride liposome injection standard-dose of cytarabine and venetoclax MAV in the treatment of relapsed or refractory RR AML The study plan to enroll 20 RR AML patients who are expected to receive laboratory tests of bone marrow and blood specimens at regular times after MAV treatment
Detailed Description:
For patients with RR AML there is currently no established standard treatment Previous research suggests that mitoxantrone could against venetoclax-resistant leukemia stem cells LSCs by modulating mitochondrial calcium levels Based on the potentially synergistic killing effect of mitoxantrone and venetoclax a phase 2 study is underway in RR AML Patients receive mitoxantrone hydrochloride liposome moderate-dose of cytarabine 10 gm2 IV q12h d1 3 5 and venetoclax MAV when they were enrolled
Here we also conduct an exploratory study of MAV regimen with standard-dose of cytarabine in relapsed or refractory RR AML aiming to evaluate the efficacy and safety of MAV regimen All participants will receive MAV treatment including 30 mgm2 mitoxantrone hydrochloride liposome on day 1 100 mgm2 cytarabine on day 1-7 and 400 mg venetoclax on day 2-10 with a dose escalation on day 2-4 Each cycle consists of 4 weeks A maximum of 2 cycles of therapy are planned
Here we also conduct an exploratory study of MAV regimen with standard-dose of cytarabine in relapsed or refractory RR AML aiming to evaluate the efficacy and safety of MAV regimen All participants will receive MAV treatment including 30 mgm2 mitoxantrone hydrochloride liposome on day 1 100 mgm2 cytarabine on day 1-7 and 400 mg venetoclax on day 2-10 with a dose escalation on day 2-4 Each cycle consists of 4 weeks A maximum of 2 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