Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 11:37 PM
Study NCT ID:
NCT05909293
Status:
RECRUITING
Last Update Posted:
2023-06-18
First Post:
2023-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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:
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 Decitabine/Azacitidine 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: 400mg/day, 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 Decitabine/Azacitidine 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: 400mg/day, 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?: