Timed-Sequential Induction in CBF-AML

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Core binding factor (CBF) acute myeloid leukemias (AML) include AMLs carrying the t(8;21) translocation as well as AMLs carrying either the inversion of chromosome 16 or translocation t(16;16). CBF-AMLs are characterized by their high sensitivity to standard chemotherapeutical agents, especially to cytarabine when administered as high-dose bolus infusions, and thus by a relative good prognosis. However, relapse rates are still comprised between 30 and 50% in these patients, even if overall survival may reach approximately 65% due to the potential salvage of late relapses.

The primary purpose of the protocol is to compare two modalities of timed-sequential induction in order to improve the results of the treatment of CBF-AML patients. This protocol also includes the biological characterization of the heterogeneity of these diseases (gene mutation and transcription profiles), as well as a centralized minimal residual disease monitoring and centralized evaluation of pharmacogenetic polymorphisms.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Acute Leukemia French Association; French Innovative Leukemia Organisation
• Treatments: Cytarabine; Daunorubicin

Criteria

Inclusion Criteria:

• Patients aged 18-60 years.

• With a newly-diagnosed de novo or therapy-related CBF-AML defined

Exclusion Criteria:

• No previously treated with any anti-leukemic agent.

• No presenting any diagnosis of uncontrolled or metastatic tumor.

• OMS performance status < 2,

• Absence of uncontrolled severe infection,

• AST and ALT 2.5 x ULN,

• Total bilirubin 1.5 x ULN,

• Serum creatinine 1.5 x ULN