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 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT04964518
Brief Summary:
This is a Phase Ib/II, open-label, multi-center study evaluating the safety, tolerability, efficacy and PK of APG-2575 in combination with Azacitidine in the patients with AML/MPAL or MDS/CMML. The study consists of dose escalation (Part I) and dose expansion phase (Part II)
Detailed Description:
The patients with histologically confirmed relapsed or refractory (R/R) AML/MPAL/CMML or relapsed/refractory Higher-Risk MDS by WHO classification for which no available standard therapies are indicated or anticipated to result in a durable response will be enrolled.
This will be a 3+3 dose escalation to determine the DLTs and MTD/RP2D of APG-2575 (see dose escalation table) given in combination with Azacitidine
Study:
NCT04964518
Study Brief:
Protocol Section:
NCT04964518