Risk-adapted Therapy for Primary Acute Myeloid Leukemia

• Status: Recruiting
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias
• Treatments: Idarubicin

Criteria

Inclusion Criteria:

• Patients with newly diagnosed AML, classified using the World Health Organization (WHO) 2017 criteria.

• Patients with 70 years old or younger.

Exclusion Criteria:

• Patients previously treated for the AML with chemotherapy different from hydroxyurea.

• Acute promyelocytic leukemia with t(15;17).

• Chronic myeloid leukemia in blastic phase.

• Secondary AML or therapy related AML.

• Presence of concomitant active neoplastic disease.

• Abnormal renal and hepatic functions with creatinin and/or bilirubin 2 times higher than the normal threshold, except when the alteration should be attributed to the leukemia.

• Patients with a cardiac ejection fraction below 45%, symptomatic cardiac deficiency or both.

• Patients with neurological or concomitant psychiatric disease.

• HIV infection.