Di Novo Acute Myeloid Leukemia Clinical Trial
Official title:
Treatment of di Novo Acute Myeloid Leukemia With the Combination of Increasing Doses of Idarubicin, Cytarabine and Sensitization (Priming) With G-CSF. A Phase II Prospective Study of Toxicity and Efficacy.
While several studies have been reported with increasing doses of daunorubicin in the first
line treatment of Acute Myeloid Leukemia (AML), there is no similar experience with
idarubicin as initial treatment of AML.
As idarubicin is the most common treatment used for AML, it is needed to find the optimal
dose for the combination of idarubicin, cytarabine and G_CSF, to explore if this combination
improves the outcomes of current treatments for AML.
The aim of this dose-finding study is to find the optimal dose for the combination of
idarubicin, cytarabine and G-CSF that could improve the response rate, reduce relapse and
improve survival of patients with primary acute myeloid leukemia. This could be a
significant advance in a field where treatment outcomes have stabilized in the last 15
years. This study will be the basis for further prospective, randomized, multicenter trial
comparing idarubicin maximum tolerated dose, compared to standard treatment with idarubicin
and cytarabine, including raising both arms in G-CSF. The dose of 12 mg/m2 will be
administered as control arm in this future randomized study, which will investigate the
benefit of enhanced dose identified as optimal in this phase II pilot study.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment