Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06434662
Status:
RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-05-10
Brief Title:
Mitoxantrone Hydrochloride Liposome Injection Cytarabine Combined With Venetoclax in the Treatment of RR AML
Sponsor:
First Affiliated Hospital of Zhejiang University
Organization:
First Affiliated Hospital of Zhejiang University
Study Overview
Official Title:
A Phase II Study of the Safety and Efficacy of Mitoxantrone Hydrochloride Liposome Injection Cytarabine and Venetoclax in Patients With RelapsedRefractory AML
Status:
RECRUITING
Status Verified Date:
2024-03
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:
The goal of this study is to evaluate the efficacy and safety of a combination regimen of mitoxantrone hydrochloride liposome injection cytarabine and venetoclax MAV in the treatment of relapsed or refractory RR AML It will also tentatively explore the correlation between different biological characteristics and therapeutic efficacy The main questions it aims to answer areDose the combination regimen of MAV enhanced the composite complete remission in RR AML Participants will receive laboratory tests of bone marrow and blood specimens at regular times after MAV treatment
Detailed Description:
Acute myeloid leukemia AML is a highly aggressive hematologic malignancy with a poor prognosis The 37 regimen combining anthracyclines with cytarabine remains the standard treatment for first line treatment However about 20 of patients will develop into primary refractory disease and more than 50 of patients who achieved complete remission will eventually relapse For patients with RR AML there is currently no established standard treatment Combining the third drugs with 37 regimen is one of the clinical exploration directions
The purpose of this prospective single-center single-arm pahse II study is to evaluate the efficacy and safety of a combination regimen of mitoxantrone hydrochloride liposome injection cytarabine and venetoclax in the treatment of RR AML All participants will receive MAV treatment including 24 mgm2 mitoxantrone hydrochloride liposome on day 1 10 gm2 q12h cytarabine on day 135 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
The purpose of this prospective single-center single-arm pahse II study is to evaluate the efficacy and safety of a combination regimen of mitoxantrone hydrochloride liposome injection cytarabine and venetoclax in the treatment of RR AML All participants will receive MAV treatment including 24 mgm2 mitoxantrone hydrochloride liposome on day 1 10 gm2 q12h cytarabine on day 135 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?:
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