Status:
TERMINATED
A Randomized Study of Post-Remission Therapy in Elderly Patients With Acute Myelogenous Leukemia.
Lead Sponsor:
Acute Leukemia French Association
Collaborating Sponsors:
Assistance Publique - Hôpitaux de Paris
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
65+ years
Phase:
PHASE3
Brief 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 (s...
Detailed Description
Patients were randomized at baseline (first R1 randomization) to receive either daunorubicin (DNR) or idarubicin (IDA) as an anthracycline for induction and post-remission therapy. This first randomiz...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 1999
Trial Type :
INTERVENTIONAL
End Date :
April 1 2006
Estimated Enrollment :
465 Patients enrolled
Trial Details
Trial ID
NCT00363025
Start Date
November 1 1999
End Date
April 1 2006
Last Update
February 21 2008
Active Locations (13)
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1
Hopital Avicenne
Bobigny, France
2
Hopital Percy
Clamart, France
3
Hopital Henri Mondor
Créteil, France
4
CHU
Lille, France