Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 12:03 AM
NCT ID:
NCT06532058
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 relapsed/refractory 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 capsule（40mgBID,60mgBID and 80mgBID） combined with Venclexta and azacitidine, to evaluate the efficacy of the three-drug combination in subjects with relapsed/refractory acute myeloid leukemia (R/R-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 capsule（60mgBID and 80mgBID）combined 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:
NCT06532058
Study Brief:
Protocol Section:
NCT06532058