Acute Myeloid Leukemia Clinical Trial
Official title:
A Single-arm Phase II Trial to Assess the Efficacy of Midostaurin (PKC412) Added to Standard Primary Therapy in Patients With Newly Diagnosed c-KIT or FLT3-ITD Mutated t(8;21) AML
To assess the efficacy of tyrosine-kinase inhibitor midostaurin in c-KIT or FLT3-ITD mutated t(8;21) AML. To assess the efficacy of midostaurin depending on the type of c-KIT mutation
AML patients displaying t(8;21) have a relatively favourable outcome. Nevertheless, only
approximately 50% of patients carrying this cytogenetic aberration are alive at 5 years. This
suggests that some patients have more aggressive leukemic phenotypes and indicates the need
for treatment optimization with novel therapies.
The mutated KIT gene as well as the FLT3-ITD mutation have recently been identified as
factors most likely to explain the heterogeneous clinical outcomes within the group of
t(8;21) AML. The FLT3 and c-KIT genes encode type III receptor tyrosine kinases (RTK) with
important and partly redundant functions in early hematopoietic stem cells. Various
activating mutations have been described for both genes. For c-KIT, the incidence ranges from
17 to 48% depending on the source population and type of mutations determined. It has been
consistently shown that in AMLs with t(8;21), mutated c-KIT is associated with a dramatically
increased risk of relapse and reduced overall survival compared to their unmutated
counterparts. The FLT3-ITD mutation has a similar negative effect on prognosis in the patient
group of t(8;21) mutated AMLs as c-KIT.
PKC412 (midostaurin) is known to inhibit the c-KIT RTK activity as well as the FLT3 kinase,
both in patients with ITD and TKD mutations. It should therefore be possible to abrogate the
negative impact of pathologically increased c-KIT or FLT3-ITD activity on relapse and overall
survival by using midostaurin in this patient population. Aim of the proposed clinical trial
is to prove the efficacy of midostaurin in c-KIT or FLT3-ITD mutated t(8;21)- AMLs in an
open-label one-arm design.
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