Risk-adapted Therapy for Primary Acute Myeloid Leukemia
Status:
Recruiting
Trial end date:
2021-10-01
Target enrollment:
Participant gender:
Summary
The AML-12 study investigates the efficacy and toxicity of standard induction chemotherapy
with idarubicin and cytarabine (IC) with G-CSF priming followed by a risk-adapted post
remission therapy for patients up to the age of 70 diagnosed with de novo acute myeloid
leukemia (AML).
Modifications from the previous protocol AML-03 (NCT01723657) include removal of etoposide in
induction, limitation of the GCSF priming to the induction phase and categorization of post
remission therapy (stem cell transplant or 2 high dose cytarabine consolidations) according
to diagnostic genetics as well as post-remission clearance of measurable residual disease.
The aims of these modifications are to improve the overall survival and leukemia free
survival of acute myeloid leukemia patients with a risk-adapted approach.
Phase:
N/A
Details
Lead Sponsor:
Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias