ALIDHE
Research type
Research Study
Full title
A single arm, open-label Phase 3b study to describe the safety and tolerability of ivosidenib in combination with azacitidine in adult patients newly diagnosed with IDH1m acute myeloid leukemia (AML) ineligible for intensive induction chemotherapy.
IRAS ID
1007001
Contact name
Hélène Derrien
Contact email
Sponsor organisation
SERVIER AFFAIRES MÉDICALES
Research summary
The purpose of this study is to learn more about the safety and efficacy of the medication
ivosidenib taken with azacitidine to treat adult patients with acute myeloid leukemia (AML) who
are presenting a particular gene mutation called IDH1 (isocitrate dehydrogenase1
mutation-positive [IDH1m]) and cannot receive treatment with intensive chemotherapy (IC). The
AGILE study showed that newly diagnosed patients who received ivosidenib + azacitidine had a
better response than patients who received azacitidine + a placebo. The present study will collect
additional information on the safety of this treatment regimen. It will also collect information
related to how well the treatment works outside of a clinical trial setting and will assess the
impact on the patient’s and their family’s quality of life. The proportion of days spent at home or
receiving healthcare will also be evaluated. To participate in this study, patients must
be ≥18 years of age, newly diagnosed with IDH1m AML and be ineligible for treatment with IC.
Patients will receive ivosidenib from the study sponsor until it is available as a commercial
product from their medical provider. Azacitidine will be provided by the patient’s medical
provider for this study. Patients will be followed for 112 weeks (28 cycles) while on treatment.
After 112 weeks (28 cycles) or earlier treatment discontinuation, patients will be contacted every
12 weeks through the end of the study (planned by 2026) to assess survival. All patients must
sign and date the informed consent form prior to enrollment into this study. Prior to the study
starting, this study will be approved by an independent ethics committee to ensure the study is
ethical and causes no harm to patients enrolled.REC name
London - Fulham Research Ethics Committee
REC reference
23/LO/0053
Date of REC Opinion
11 Dec 2023
REC opinion
Further Information Favourable Opinion