A Randomized Study of Post-Remission Therapy in Elderly Patients With Acute Myelogenous Leukemia.
A Randomized Multicenter Study of More Intensive Versus Less Intensive Post-Remission Therapy in Elderly Patients With Acute Myelogenous Leukemia (AML) or Transformed Refractory Anemia With Excess Blasts (RAEB-t).
1 other identifier
interventional
465
1 country
13
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 (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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 1999
Longer than P75 for phase_3
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 1999
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 11, 2006
CompletedFirst Posted
Study publicly available on registry
August 15, 2006
CompletedFebruary 21, 2008
August 1, 2006
August 11, 2006
February 20, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival
Secondary Outcomes (2)
Complete remission rate
Induction death rate
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Hopital Avicenne
Bobigny, France
Hopital Percy
Clamart, France
Hopital Henri Mondor
Créteil, France
CHU
Lille, France
CHU
Limoges, France
Hopital Edouard Herriot
Lyon, France
Hopital Pitie-Salpetriere
Paris, France
Hopital Saint-Louis
Paris, France
CHU
Rouen, France
CNLCC
Rouen, France
CNLCC
Saint-Cloud, France
CH
Versailles, France
IGR
Villejuif, France
Related Publications (4)
Sarkozy C, Gardin C, Gachard N, Merabet F, Turlure P, Malfuson JV, Pautas C, Micol JB, Thomas X, Quesnel B, Celli-Lebras K, Preudhomme C, Terre C, Fenaux P, Chevret S, Castaigne S, Dombret H. Outcome of older patients with acute myeloid leukemia in first relapse. Am J Hematol. 2013 Sep;88(9):758-64. doi: 10.1002/ajh.23498. Epub 2013 Aug 7.
PMID: 23749683DERIVEDGardin C, Chevret S, Pautas C, Turlure P, Raffoux E, Thomas X, Quesnel B, de Revel T, de Botton S, Gachard N, Renneville A, Boissel N, Preudhomme C, Terre C, Fenaux P, Bordessoule D, Celli-Lebras K, Castaigne S, Dombret H. Superior long-term outcome with idarubicin compared with high-dose daunorubicin in patients with acute myeloid leukemia age 50 years and older. J Clin Oncol. 2013 Jan 20;31(3):321-7. doi: 10.1200/JCO.2011.40.3642. Epub 2012 Dec 17.
PMID: 23248249DERIVEDItzykson R, Gardin C, Pautas C, Thomas X, Turlure P, Raffoux E, Terre C, Fenaux P, Castaigne S, Dombret H, Boissel N; Acute Leukemia French Association (ALFA). Impact of post-remission therapy in patients aged 65-70 years with de novo acute myeloid leukemia: a comparison of two concomitant randomized ALFA trials with overlapping age inclusion criteria. Haematologica. 2011 Jun;96(6):837-44. doi: 10.3324/haematol.2010.036921. Epub 2011 Apr 1.
PMID: 21459791DERIVEDMalfuson JV, Etienne A, Turlure P, de Revel T, Thomas X, Contentin N, Terre C, Rigaudeau S, Bordessoule D, Vey N, Gardin C, Dombret H; Acute Leukemia French Association (ALFA). Risk factors and decision criteria for intensive chemotherapy in older patients with acute myeloid leukemia. Haematologica. 2008 Dec;93(12):1806-13. doi: 10.3324/haematol.13309. Epub 2008 Oct 6.
PMID: 18838471DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Herve Dombret, M.D.
Acute Leukemia French Association
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 11, 2006
First Posted
August 15, 2006
Study Start
November 1, 1999
Study Completion
April 1, 2006
Last Updated
February 21, 2008
Record last verified: 2006-08