Risk Adapted Treatment for Primary Acute Myeloid Leukemia (AML)

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Patients with newly diagnosed AML, classified using OMS criteria.

• Patients with 70 years old or younger.

Exclusion Criteria:

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

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

• Cronic mieloid leukemia in blastic crisis.

• Leukemias that appear after other myeloproliferative processes.

• Leukemias that survive after myelodysplasic syndromes of more than 6 months of evolution.

• Presence of other neoplasic disease in activity.

• Secondary AML which appears after cured malignant disease (for instance, Hodgking disease), and those who are still exposed to alkilant agents or radiation.

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

• Patient with an ejection fraction below 40%, symptomatic cardiac deficiency or both.

• Patients with neurological or concomitant psychiatric disease.

• Positivity by HIV.