Patient involvement in the design of ALIDHE: a study of ivosidenib + azacitidine in newly diagnosed <i>IDH1</i> mutant AML.

ABSTRACT:

Aims

The ALIDHE study aims to supplement previous clinical trial data by evaluating the safety and tolerability of ivosidenib + azacitidine in adult patients with newly diagnosed mutant isocitrate dehydrogenase acute myeloid leukemia (AML).

Methods

Notably, this study has been designed in collaboration with patient representatives from the Acute Leukemia Advocates Network (ALAN) at all stages. Patient representatives from ALAN completed a survey and attended workshops to share feedback on the study design to reduce the burden of participation for patients. Using feedback from ALAN, the study protocol was adjusted to minimize clinical visits and optimize study duration. Quality of life and mental health were included as endpoints in ALIDHE as these outcomes have been recogniz

SUBMITTER: Nier S 

PROVIDER: S-EPMC12688226 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature