Lomustine and Intermediate Dose Cytarabine in Older Patients With AML

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

Summary

A multicenter randomized trial was performed comparing induction therapy (IC: Idarubicin and Cytarabine, 5+7) to ICL (the same drugs plus lomustine (CCNU), 200mg\m2 orally at day 1). Patients in complete remission (CR) were then randomized to receive either maintenance therapy or intensification with intermediate-dose cytarabine and idarubicin followed by maintenance therapy.

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

Details

• Lead Sponsor: French Innovative Leukemia Organisation
• Treatments: Cytarabine; Lomustine

Criteria

Inclusion Criteria:

• Patients aged 60 years and older with de novo AML according to FAB criteria

• With normal cardiac function with left ventricular ejection fraction >= 50%, absence of unstable cardiac arrhythmia or unstable angina.

• Unimpaired renal (creatinin <180µmol\L)

• Unimpaired liver (bilirubin <35µmol\L) functions.

• Performance status <3

• Signed and dated informed consent.

Exclusion Criteria:

• Acute promyelocytic leukemia

• Patients with myeloproliferative syndromes prior to diagnosis of AML

• Patients who previously had myelodysplastic syndrome

• Patients pretreated with chemo- or radiotherapy

• Performance status <2

• Positive serology for HIV