Risk-adapted Therapy for Primary Acute Myeloid Leukemia

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.

Conditions

• Leukemia, Myeloid, Acute

Interventions

DRUG

Idarubicin

12 mg/m2/day; intravenous, administration at induction phase, days 1 to 3.

DRUG

Ara-C

200mg/m2/day, intravenous at induction phase; days 1-7. \- High dose during consolidation phase. In patients up to 60 years 3g/m2/12hours days 1,3,5, and patients 60 to 70 years: 1.5g/m2/12hours days 1,3,5.

DRUG

G-CSF

* Administration at induction phase to remission days 1 to 7. G-CSF will not be initiated if the leukocyte count is over 30x10e9/L at diagnosis or will be interrupted if the leukocyte count during treatment arises 30x10e9/L. * Administration at consolidation phase day 7.

PROCEDURE

Allogeneic matched or unrelated donor transplant.

To be performed in patients in the intermediate or adverse risk groups.

PROCEDURE

Autologous peripheral blood stem cell transplant

To be considered in patients in the intermediate risk group without an available allogeneic donor and negative measurable residual disease, per center decision.

PROCEDURE

Measurable residual disease

To be performed either with molecular monitoring or, if not applicable, by flow cytometry. Pre-stablished cut-off values are defined for decision-making.

Sponsors & Collaborators

• Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias

  lead OTHER

Principal Investigators

• Jorge Sierra, Prof, MD · Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

• Jordi Esteve, MD, PhD · Hospital Clinic of Barcelona

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

17 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-02-01

Primary Completion

2022-07-31

Completion

2022-11-10

Countries

• Spain

Study Locations