Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06532058
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-20
Brief Title:
Phase IIa Study to Assess Safety and Efficacy in the RelapsedRefractory Acute Myeloid Leukemia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Safety and Efficacy of QHRD107 Capsule Combined With Venclexta and Azacitidine in the Treatment of RelapsedRefractory Acute Myeloid Leukemia a Single-arm Open Multicenter Phase IIa Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the safety and efficacy of QHRD107 capsule combined with Venclexta and azacitidine in the treatment of relapsedrefractory acute myeloid leukemia a single-arm open multicenter Phase IIa study
Detailed Description:
This study is a single-arm open multicenter phase IIa clinical study which is divided into two stages the dose-increasing study phase and the dose-expanding exploration phase The purpose of the dose-escalation phase is to explore the safety and tolerability of QHRD107 capsule40mgBID60mgBID and 80mgBID combined with Venclexta and azacitidine to evaluate the efficacy of the three-drug combination in subjects with relapsedrefractory acute myeloid leukemia RR-AML and to explore the pharmacokinetic characteristics of the combination The dose expansion stage aims to further evaluate the safety efficacy pharmacodynamics and pharmacokinetics of QHRD107 capsule60mgBID and 80mgBIDcombined with Venclexta and azacitidine on the basis of exploring the safe dose range determined in the dose escalation stage and determine the recommended dose for subsequent clinical studies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None