Overview

A Randomized Study of Post-Remission Therapy in Elderly Patients With Acute Myelogenous Leukemia.

Status:
Terminated
Trial end date:
2006-04-01
Target enrollment:
0
Participant gender:
All
Summary
In this ALFA-9803 trial in AML patients aged 65 years or more, we randomly compared idarubicin or daunorubicin throughout the study (first randomization) and two different post-remission strategies (second randomization): one single intensive consolidation course similar to induction versus six ambulatory cycles with one dose of idarubicin/daunorubicin (day 1) and 2x60 mg/m2/d cytarabine SC (day 1 to 5) delivered in out-patients on a monthly basis. Primary endpoint was 2-year overall survival (OS). Study hypotheses were equivalence for the idarubicin/daunorubicin comparison and a 15% difference in 2-year OS for the post-remission therapy comparison.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Acute Leukemia French Association
Collaborator:
Assistance Publique - Hôpitaux de Paris
Treatments:
Daunorubicin
Idarubicin
Criteria
Inclusion Criteria:

Male or female aged 65 years or more. Patient with previously untreated AML except M3 in
the FAB classification. Patient with previously untreated transformed refractory anemia
with excess blasts (RAEB-t).

Patients with AML secondary to a previously untreated myelodysplastic syndrome (MDS),
documented or not, are eligible, as well as those with RAEB-t evolving from a previous
known MDS.

Patients with a Performance Status < 3. Patient who has given his/her written informed
consent.

Exclusion Criteria:

Patients with AML3 in the FAB classification. Patients with blast crisis of previously
known myeloproliferative syndrome. Patients with AML secondary to previous treatment with
cytotoxic chemotherapy or radiotherapy (therapy-related AML).

Patients with another concommitant neoplasia. Patients with leukemic central nervous system
involvement. Patients with a Grade > 2 uncontrolled infection. Patients with Grade > 2
visceral contra-indications to treatment with induction chemotherapy (except if
leukemia-related).

Bilirubin > 2 times the normal range of the laboratory. Serum creatinine > 2 times the
normal range of the laboratory. Patients with cardiac contra-indication to treatment with
anthracyclines.