Ignite Creation Date:
2024-05-06 @ 7:08 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05909293
Status:
RECRUITING
Last Update Posted:
2023-06-18
First Post:
2023-05-26
Brief Title:
Clinical Study Protocol of Maintenance Therapy With Venetoclax in Elderly Patients With AML in First Complete Remission
Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Organization:
The First Affiliated Hospital with Nanjing Medical University
Study Overview
Official Title:
Clinical Study Protocol of Maintenance Therapy With Venetoclax in Elderly Patients With Acute Myeloid Leukemia AML in First Complete Remission
Status:
RECRUITING
Status Verified Date:
2023-06
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 clinical study evaluates the efficacy and safety of maintenance therapy with BCL-2 inhibitors in elderly patients with acute myeloid leukemia AML in first complete remission
This study involves the following content BCL-2 inhibitors
This study involves the following content BCL-2 inhibitors
Detailed Description:
This is a prospective multicenter open-label single-arm clinical study that aims to observe the efficacy and safety of maintenance therapy with BCL-2 inhibitors in elderly patients with acute myeloid leukemia AML in first complete remission
The FDA has approved the combination therapy of Venetoclax and DecitabineAzacitidine for elderly 60 years old newly diagnosed AML patients who are not eligible for intensive chemotherapy Venetoclax the first highly selective BCL-2 inhibitor available globally is a BH3 mimetic that selectively binds to the BCL-2 protein displacing and releasing pro-apoptotic proteins that were originally bound to BCL-2 effectively inducing apoptosis in tumor cells
In recent years maintenance therapy for elderly AML patients has also been under continuous exploration In 2020 Andrew et al published clinical trial results in the New England Journal of Medicine demonstrating the use of oral Azacitidine formulation CC-486 as maintenance therapy for elderly AML patients who achieved their first complete remission CR1
Considering the high response rate achieved by BCL-2 inhibitors in treating elderly AML and the tolerable adverse effects maintenance therapy has shown survival benefits and good safety profiles in elderly AML patients Therefore your plan is to further explore refine and optimize treatment strategies for elderly AML patients by administering BCL-2 inhibitor maintenance therapy to those who have achieved their first CR evaluating patient overall survival OS relapse-free survival RFS and treatment safety through a comparative study with a control group This aims to preliminarily establish the role of this maintenance regimen in the treatment of elderly AML
Participants will be recruited within 24 months from the completion of consolidation therapy and the BCL-2 inhibitor maintenance therapy will last for 12 cycles with each cycle consisting of 28 days The analysis will be conducted approximately 48 months after the enrollment of the first patient and the follow-up will continue for 2 years from the randomization of the last patient
Specific protocol
During the consolidation phase which occurs within 2 months after the completion of consolidation therapy the BCL-2 inhibitor maintenance treatment will consist of 12 cycles with each cycle lasting 28 days
The specific regimen for the BCL-2 inhibitor is as follows
BCL-2 inhibitor 400mgday orally from day 1 to day 14 of each cycle
The target is to enroll 100 eligible patients
The FDA has approved the combination therapy of Venetoclax and DecitabineAzacitidine for elderly 60 years old newly diagnosed AML patients who are not eligible for intensive chemotherapy Venetoclax the first highly selective BCL-2 inhibitor available globally is a BH3 mimetic that selectively binds to the BCL-2 protein displacing and releasing pro-apoptotic proteins that were originally bound to BCL-2 effectively inducing apoptosis in tumor cells
In recent years maintenance therapy for elderly AML patients has also been under continuous exploration In 2020 Andrew et al published clinical trial results in the New England Journal of Medicine demonstrating the use of oral Azacitidine formulation CC-486 as maintenance therapy for elderly AML patients who achieved their first complete remission CR1
Considering the high response rate achieved by BCL-2 inhibitors in treating elderly AML and the tolerable adverse effects maintenance therapy has shown survival benefits and good safety profiles in elderly AML patients Therefore your plan is to further explore refine and optimize treatment strategies for elderly AML patients by administering BCL-2 inhibitor maintenance therapy to those who have achieved their first CR evaluating patient overall survival OS relapse-free survival RFS and treatment safety through a comparative study with a control group This aims to preliminarily establish the role of this maintenance regimen in the treatment of elderly AML
Participants will be recruited within 24 months from the completion of consolidation therapy and the BCL-2 inhibitor maintenance therapy will last for 12 cycles with each cycle consisting of 28 days The analysis will be conducted approximately 48 months after the enrollment of the first patient and the follow-up will continue for 2 years from the randomization of the last patient
Specific protocol
During the consolidation phase which occurs within 2 months after the completion of consolidation therapy the BCL-2 inhibitor maintenance treatment will consist of 12 cycles with each cycle lasting 28 days
The specific regimen for the BCL-2 inhibitor is as follows
BCL-2 inhibitor 400mgday orally from day 1 to day 14 of each cycle
The target is to enroll 100 eligible patients
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