Ignite Creation Date:
2024-07-17 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06497062
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-06-25
Brief Title:
Phase II Study of Sonrotoclax Combined With Chemotherapy in the Treatment of Newly Diagnosed Acute Myeloid Leukemia
Sponsor:
Shanghai Jiao Tong University School of Medicine
Organization:
Shanghai Jiao Tong University School of Medicine
Study Overview
Official Title:
Risk-stratified Treatment of Sonrotoclax Combined With Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia a Multicenter Phase II Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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 single-armed study aims to investigate the safety and efficacy of sonrotoclax in combination with intensive chemotherapy in subjects with newly diagnosed AML Subjects will be stratified based on the genetic risk classification of 2022 European LeukemiaNet ELN recommendations and MRD status to receive specific consolidation therapy after the induction therapy
Detailed Description:
47 subjects who meet the eligibility criteria will receive no more than 2 cycles each cycle is 28 days of induction therapy with sonrotoclax on day5-14 combined with the standard 37 intensive chemotherapy regimen 37 regimen containing cytarabine and daunorubicin or idarubicin In cycleC1 of induction therapy sonrotoclax will be administered orally once daily by a 4-day dose rump-up of 20mg on DayD5 40mg on D6 80mg on D7 and 160mg on D8-14 The first 6 subjects will be enrolled in a Safety Run-in period in C1 to assess tolerability and determine the final sonrotoclax regimen Within 42 days or before the next cycle of therapy if 1 of 6 subjects has dose-limiting toxicities DLT the study will be continued with the sonrotoclax dose regimen as above and if 2 of 6 subjects have DLTs the dose will be adjusted Adjustment may include reducing the dose shortening the duration of each cycle or terminating the study based on the DLTs characteristics
Subjects who achieve a composite complete remission CRc after induction therapy will receive further consolidation therapy which regimen will be decided based on the ELN risk at diagnosis and MRD status detected by MFC after induction therapy
After consolidation subjects will receive once daily sonrotoclax orally combined with azacitidine AZA subcutaneously once daily alternating with AZA monotherapy every 2 cycles as maintenance therapy until unacceptable toxicity 12 months recurrence death withdrawal of informed consent or study termination determined by investigators
This single-armed study aims to investigate the safety and efficacy of a risk-stratified regimen of sonrotoclax in combination with intensive chemotherapy in subjects with newly diagnosed AML
Subjects who achieve a composite complete remission CRc after induction therapy will receive further consolidation therapy which regimen will be decided based on the ELN risk at diagnosis and MRD status detected by MFC after induction therapy
After consolidation subjects will receive once daily sonrotoclax orally combined with azacitidine AZA subcutaneously once daily alternating with AZA monotherapy every 2 cycles as maintenance therapy until unacceptable toxicity 12 months recurrence death withdrawal of informed consent or study termination determined by investigators
This single-armed study aims to investigate the safety and efficacy of a risk-stratified regimen of sonrotoclax in combination with intensive chemotherapy in subjects with newly diagnosed AML
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