Status:

COMPLETED

Timed-Sequential Induction in CBF-AML

Lead Sponsor:

Assistance Publique - Hôpitaux de Paris

Collaborating Sponsors:

Acute Leukemia French Association

French Innovative Leukemia Organisation

Conditions:

Acute Myeloid Leukemia

Eligibility:

All Genders

18-60 years

Phase:

PHASE3

Brief 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-AM...

Detailed Description

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-AM...

Eligibility Criteria

Inclusion

  • Patients aged 18-60 years.
  • With a newly-diagnosed de novo or therapy-related CBF-AML defined

Exclusion

  • 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

Key Trial Info

Start Date :

July 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2011

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT00428558

Start Date

July 1 2007

End Date

June 1 2011

Last Update

December 20 2013

Active Locations (1)

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Service Hematologie Oncologie

Nîmes, France, 30029