ALIDHE

About this trial

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.

Patient Profile

Patients patients must be ≥18 years of age

Patients must newly diagnosed with IDH1m AML and be ineligible for treatment with IC.

All patients must sign and date the informed consent form prior to enrollment into this study.

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.

Where’s this trial being run?

Cork University Hospital and St James’s Hospital

Can I join this study / trial?

The first step we recommend is to talk to your doctor or the cancer trials team at your hospital. You can find contact details for cancer trials research units in Ireland here.

It’s also a good idea to print this page and bring it with you to your appointment. It can help guide the conversation and remind you of what to ask. You may also want to talk to your family or friends about your options, as they can offer support as you make decisions.

For more detailed information

Click Here

Questions?

Here’s a list of questions you may have for your doctor or local cancer research team.

Questions

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Summary Data

Name:	ALIDHE
Number:	24-27
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.

Principal Investigator:
Type:	Industry Sponsored
Sponsor:	Servier Affaires Medicales
Recruitment Started:	Global: Ireland:

Global Recruitment Target:	233
Ireland Recruitment Target:	6