Ivosidenib (TIBSOVO®) Combined With Azacitidine According to Current SmPC

Launched by IOMEDICO AG · Dec 12, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at the quality of life for adults with a specific type of blood cancer called Acute Myeloid Leukemia (AML) who have a mutation known as IDH1 R132. The study is focused on patients who are newly diagnosed and cannot receive the usual chemotherapy treatment. Instead, they will be treated with a combination of two drugs: ivosidenib and azacitidine. Researchers want to understand how this treatment affects patients' daily lives, how well the treatment works, and any side effects that may occur. They will use surveys to gather feedback from patients about their experiences during treatment and afterward.

To be eligible for this trial, participants need to be at least 18 years old, have a diagnosed case of AML with the IDH1 R132 mutation, and must not be able to receive standard chemotherapy. Participants should also be able to provide consent and complete assessments in German. This study is currently recruiting participants, and those who join can expect to be closely monitored for their health and well-being throughout the treatment process. It's an important step toward understanding how to improve care for patients with this type of leukemia.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 18 years or older.
• • Newly diagnosed Acute Myeloid Leukemia (AML).
• • Having an isocitrate dehydrogenase 1 (IDH1) R132 mutation.
• • Not eligible to receive standard induction chemotherapy.
• • Decision for treatment with ivosidenib in combination with azacitidine as per current SmPC.
• • Signed written informed consent\*
• • \*Patients are allowed to be enrolled up to 6 weeks after ivosidenib plus azacitidine dose
• • For patients participating in PROs: Willingness and capability to participate in PRO assessment in German language
• • Other criteria according to current SmPC.
• Exclusion Criteria:
• • Participation in an interventional clinical trial within 30 days prior to enrollment or simultaneous participation in an interventional clinical trial except for the follow-up period.
• • Patients unable to consent
• • Other contraindications according to current SmPC.