Ignite Creation Date:
2024-05-06 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05807347
Status:
RECRUITING
Last Update Posted:
2023-04-11
First Post:
2023-02-27
Brief Title:
Venetoclax Combined With Azacitidine and CAG in RefractoryRelapse Acute Myeloid Leukemia
Sponsor:
Hematology department of the 920th hospital
Organization:
Hematology department of the 920th hospital
Study Overview
Official Title:
Phase II Trial of Venetoclax in Combination With Azacitidine and CAG as Induction Therapy in Patients With RefractoryRelapse Acute Myeloid Leukemia
Status:
RECRUITING
Status Verified Date:
2023-02
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 study aims to assess the therapeutic efficacy and safety of venetoclax in combination with azacitidine and CAG as induction regimen in Patients with RefreactoryRelapse Acute Myeloid Leukemia
Detailed Description:
This is an open-label multicenter phase II clinical trial to assess the therapeutic efficacy and safety of venetoclax in combination with azacitidine VA and CAG G-CSF priming low dose cytarabine and aclarubicin as induction regimen in Patients with RefreactoryRelapse Acute Myeloid LeukemiaAML
Previous studies have shown that venetoclax plus intense chemotherapy represent promising efficacy in de novo AML patients with high complete remission rates and good tolerance Our preliminary results suggest that venetoclax in combination with azacitidine and CAG are well tolerated and effective for patients who were diagnosed with refreactoryrelapse AML Thus this phase II clinical trial is going to further explore its efficacy and safety It is expected that about 42 patients will take part in this trial
Previous studies have shown that venetoclax plus intense chemotherapy represent promising efficacy in de novo AML patients with high complete remission rates and good tolerance Our preliminary results suggest that venetoclax in combination with azacitidine and CAG are well tolerated and effective for patients who were diagnosed with refreactoryrelapse AML Thus this phase II clinical trial is going to further explore its efficacy and safety It is expected that about 42 patients will take part in this trial
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