Efficacy and Toxicity of Increasing Doses of Idarubicin, Cytarabine and G-CSF in Acute Myeloid Leukemia
Status:
Completed
Trial end date:
2015-04-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2
Details
Lead Sponsor:
Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias
Collaborators:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau Ministry of Health, Spain