Risk Adapted Treatment for Primary Acute Myeloid Leukemia (AML)

Summary

The AML-03 regimen investigates the addition of G-CSF priming to both induction and consolidation chemotherapies administrated in the previous AML-99 trial (NCT01716793) refines risk-stratification based on biological characterization also the AML-03 trial incorporates novel approaches for hematopoietic stem cell transplantation: such as Mylotarg™ "in vivo purging" in autografts, extends unrelated volunteers donors for allotransplants in high-risk patients, and introduces reduced intensity conditioning in patients with elder age (more than 50 years old).

The aims of these modifications are to analyse eficacy and toxicity of this induction and consolidation therapy and to analyse the disease free survival in patients who achieved complete response following a risk adjusted therapy.

Conditions

• Leukemia, Myelocytic, Acute

Interventions

DRUG

Ara-C

* Intermediate dose during induction phase to remission. * High dose during consolidation phase in patients with favorable cytogenetics and leukocyte index below 20.

OTHER

Autologous peripheral blood stem cell transplantation.

* In patients with favorable cytogenetics with a Leukocyte index above 20. * Patients with normal karyotype, and one cycle of chemotherapy to achieve complete remission, without adverse molecular and/or minimal residual disease (MRD) characteristics, regardless availability of a matched donor.

OTHER

Allogeneic matched related or unrelated donor transplant.

-Patients without favorable/intermediate characteristics.

DRUG

G-CSF

* Administration at induction phase to remission, days 0 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 treatmen arises 30x10e9/L. * Administration at consolidation phase, days 4 to 6 (3 doses). G-CSF will be interrupted if the leukocyte count during treatment arises 30x10e9/L.

OTHER

CD34+ selection.

-Patients with adverse prognosis with allogeneic peripheral blood stem cell (PBSC)tranplantation, CD34+ cell selection of the inoculum was performed.

OTHER

Mylotarg purging before autologous PBSC transplantation

Patients without favorable/intermediate characteristics and without matched related donor.

Sponsors & Collaborators

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

  lead OTHER

Principal Investigators

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

• Salut Brunet, MD · Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2003-10-31

Primary Completion

2012-03-31

Completion

2012-03-31

Countries

• Spain

Study Locations