Overview
A Randomized Study of Post-Remission Therapy in Elderly Patients With Acute Myelogenous Leukemia.
Status:
Terminated
Terminated
Trial end date:
2006-04-01
2006-04-01
Target enrollment:
0
0
Participant gender:
All
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 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Acute Leukemia French AssociationCollaborator:
Assistance Publique - Hôpitaux de ParisTreatments:
DaunorubicinIdarubicin
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.