Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06449482
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2023-06-13
Brief Title:
SelinexorVenetoclax and Azactidine in the Treatment of ND AML Patients Who Are Not Eligible for Intense Chemotherapy
Sponsor:
Institute of Hematology Blood Diseases Hospital China
Organization:
Institute of Hematology Blood Diseases Hospital China
Study Overview
Official Title:
An Exploratory Clinical Study of Selinexor Combined With Venetoclax and Azactidine in the Treatment of Acute Myeloid Leukemia Patients Who Are Not Eligible for Intense Chemotherapy Regimen at Initial Treatment
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:
This study is a single arm open exploratory clinical trial to evaluate the efficacy and safety of selinexor combined with venetoclax and azacitidine This study will be divided into two stages dose increasing stage and dose expanding stage In the dose-increasing stage the study induction therapy was designed using a 33 design The induction therapy and consolidation therapy of the subjects will be administered at RP2D doses
During this study period there were a total of 4 cycles The treatment cycle of the subjects will include 2 cycles of induction therapy and up to 2 cycles of consolidation therapy
In addition if the subject does not achieve remission CRCr or PR after 2 cycles of consolidation treatment at the end of the 4th course the study will be terminated by the subject and the clinical doctor will choose the subsequent treatment for the subject based on clinical experience
During this study period there were a total of 4 cycles The treatment cycle of the subjects will include 2 cycles of induction therapy and up to 2 cycles of consolidation therapy
In addition if the subject does not achieve remission CRCr or PR after 2 cycles of consolidation treatment at the end of the 4th course the study will be terminated by the subject and the clinical doctor will choose the subsequent treatment for the subject based on clinical experience
Detailed Description:
This study is a single arm open exploratory clinical trial to evaluate the efficacy and safety of selinexor combined with venetoclax and azacitidine This study will be divided into two stages dose increasing stage and dose expanding stage In the dose-increasing stage the study induction therapy was designed using a 33 design In this stage three dosage groups were set up namely selinexor 60mg QW 40mg BIW or 60mg BIW in combination with venetoclax 100mg d1 200mg d2 400mg d3-28 orally once a day and azacitidine 75mgm2 d1-7 subcutaneously The regimen was repeated every 28 days In this case RP2D is determined based on MTD safety and all other data
The methods of venetoclax and azacitidine remain unchanged during consolidation therapy Before RP2D is determined the dosage of selinexor is determined by the researchers based on individual subject tolerance After RP2D is determined the study enters the second stage of dose expansion The induction therapy and consolidation therapy of the subjects will be administered at RP2D doses
During this study period there were a total of 4 cycles The treatment cycle of the subjects will include 2 cycles of induction therapy and up to 2 cycles of consolidation therapy In addition if the subject does not achieve remission CRCr or PR after 2 cycles of consolidation treatment at the end of the 4th course the study will be terminated by the subject and the clinical doctor will choose the subsequent treatment for the subject based on clinical experience
The subjects will participate in the screening period treatment period and follow-up period The screening period lasts for a maximum of 28 days before medication The treatment period lasts from the first day of the first cycle to the end of the study treatment The follow-up period starts after the end of treatment and lasts for at least 12 months
The methods of venetoclax and azacitidine remain unchanged during consolidation therapy Before RP2D is determined the dosage of selinexor is determined by the researchers based on individual subject tolerance After RP2D is determined the study enters the second stage of dose expansion The induction therapy and consolidation therapy of the subjects will be administered at RP2D doses
During this study period there were a total of 4 cycles The treatment cycle of the subjects will include 2 cycles of induction therapy and up to 2 cycles of consolidation therapy In addition if the subject does not achieve remission CRCr or PR after 2 cycles of consolidation treatment at the end of the 4th course the study will be terminated by the subject and the clinical doctor will choose the subsequent treatment for the subject based on clinical experience
The subjects will participate in the screening period treatment period and follow-up period The screening period lasts for a maximum of 28 days before medication The treatment period lasts from the first day of the first cycle to the end of the study treatment The follow-up period starts after the end of treatment and lasts for at least 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None