Patient involvement in the design of ALIDHE: a study of ivosidenib + azacitidine in newly diagnosed IDH1 mutant AML.
Nier S., Pelouchova J., Hills R., Salek S., Derrien H., Chatin S., De La Bigne A-M., Vives S., Recher C., Döhner H., Venditti A., Vyas P.
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 recognized as important to capture the lived experiences of patients with AML. Efforts were made to ensure patient comprehension through accessible study documents such as a plain language video and one-page summary. CONCLUSIONS: ALIDHE represents, to our knowledge, the first AML clinical trial that involves patient representatives from development of the study concept to follow-up. ALAN will continue to be involved in ALIDHE as part of the patient steering committee, to ensure that patient perspectives and needs continue to be considered throughout the study duration.