SEL24/MEN1703 in Patients With Acute Myeloid Leukemia
18 Years and older, Male and Female
CLI24-001 (primary)
NCI-2017-00611
Summary
The purpose of the clinical trial is to identify the maximum tolerated dose of
SEL24/MEN1703 and to further investigate its safety profile in patients with Acute
Myeloid Leukemia.
Objectives
Phase I/II, open-label, multi-center, dose escalation study to estimate the maximum
tolerated dose of SEL24/MEN1703 in patients with Acute Myeloid Leukemia.
The clinical trial will investigate the safety profile and anti-leukemic activity of
SEL24/MEN1703 in patients with Acute Myeloid Leukemia and that have no standard
therapeutic options available.
The clinical trial encompasses two parts:
- Part 1, ascending dose levels: the main purpose of this part of the clinical trial
is to determine the highest dose of SEL24/MEN1703 considered to be well tolerated.
- Part 2: Expansion cohort: the main purpose of this part of the clinical trial is to
assess the safety and anti-leukemia activity of SEL24/MEN1703 given at the highest
tolerated dose in patient with relapsed/refractory Acute Myeloid Leukemia, either
all comers as well as harboring IDH1/IDH2 mutations.
Patients participating to the clinical trial will take the study drug as oral capsules
once daily for 14 consecutive days over a 21-day treatment cycle.
Eligibility
- patients with diagnosis of Acute Myeloid Leukemia, all comers (completed) and bearing IDH1 or IDH2 mutation (open for recruitment)
- Patient has no standard therapeutic options available and has either Relapsed AML unsuitable for intensive chemotherapy and not eligible for any approved targeted therapy or Primary refractory AML unsuitable for intensive chemotherapy and not eligible for any approved targeted therapy
Treatment Sites in Georgia
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