Adding Lomustine to Chemotherapy in Older Patients With Acute Myelogenous Leukemia (AML), and Allogeneic Transplantation for Patients From 60 to 65 Years Old

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

A multicenter randomized trial comparing induction therapy (IC: Idarubicin and Cytarabine, 5 + 7) to ICL (the same drugs plus lomustine (CCNU), 200 mg/m2 orally at day 1). Patients in complete remission (CR) will then receive a post-remission schedule with or without lomustine according to randomization. Patients from 60 to 65 years old will be proposed to reduced conditioning allogeneic transplantation after first consolidation.

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

Details

• Lead Sponsor: University Hospital, Bordeaux
• Treatments: Lomustine

Criteria

Inclusion Criteria:

• Patients aged 60 years and older with de novo AML and non-poor cytogenetic features.

• Patients with no unfavourable cytogenetic (based on GOELAMS-BGMT criteria)

• Performance status and Sorror score < 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.

• Positive serology for HIV.

• Patients with unfavourable cytogenetic

• Patients with an isolated medullary extra localization of their disease