Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
330 participants
INTERVENTIONAL
2002-06-30
2008-05-31
Brief Summary
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Detailed Description
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* Idarubicin, 8mg/m2 d1-5; Cytarabine, 100mg/m2 d1-7 and Lomustine, 200mg/m d1
* if CR or PR: randomisation = maintenance therapy including or not androgens
* Maintenance therapy :
* 6 courses of reinduction with idarubicin (8mg/m2 d1) and cytarabine (100mg/m2d1-5, subcutaneously) every 3 months, and, between these courses, a continuous regimen of methotrexate and 6-mercaptopurine.
* Patients randomized with androgens additionally received 10 to 20 mg according to body weigh of norethandrolone daily for up to 2 years
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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B
* Induction therapy Idarubicin, 8mg/m2 d1-5; Cytarabine, 100mg/m2 d1-7 and Lomustine, 200mg/m d1) If CR ou PR
* maintenance therapy every 3 months = 6 courses of reinduction with :
-idarubicin (8mg/m2 d1),cytarabine (100mg/m2d1-5 ), subcutaneously
* between the courses, a continuous regimen of methotrexate and 6-mercaptopurine.
chemotherapy treatment (see arms)
Induction chemotherapy + maintenance chemotherapy
A
* Induction therapy Idarubicin, 8mg/m2 d1-5; Cytarabine, 100mg/m2 d1-7 and Lomustine, 200mg/m d1) If CR ou PR
* maintenance therapy every 3 months = 6 courses of reinduction with :
* idarubicin (8mg/m2 d1),cytarabine (100mg/m2d1-5, subcutaneously)
* 10 to 20 mg (according to body weigh) of norethandrolone daily
* between the courses, a continuous regimen of methotrexate and 6-mercaptopurine.
chemotherapy treatment (see arm) + norethandrolone
oral form
Dosage:
10 mg in patients with a weight \< 60 kgs 20 mg in patients with a weight \> 60 kgs frequency: every day Duration: 2 years
Interventions
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chemotherapy treatment (see arm) + norethandrolone
oral form
Dosage:
10 mg in patients with a weight \< 60 kgs 20 mg in patients with a weight \> 60 kgs frequency: every day Duration: 2 years
chemotherapy treatment (see arms)
Induction chemotherapy + maintenance chemotherapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* "de novo" AML according to FAB criteria
* AML with 20% or more myeloid marrow blasts
* signed and dated informed consent
* OMS score \< 3
* Life expectancy \> 1 month
Exclusion Criteria
* or AML M3
* or not classificated according to FAB criteria
* or extramedular localisation of AML
* OMS score ≥ 3
* clinical Abnormal Cardiac fonction or with left ejection fraction \< 40 %
* abnormal renal function with creatinine clearance \< 50/ml/mn/m²
* abnormal hepatic function
* previous cerebral stroke
* previous malignancy : prostate, breast cancer (males)
* PSA dosage \> 4
* Any coexisting medical or psychological condition that would pleclude participation in the required study procedures
60 Years
ALL
No
Sponsors
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French Innovative Leukemia Organisation
OTHER
BGMT
UNKNOWN
University Hospital, Grenoble
OTHER
Responsible Party
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GOELAMS BGMT
Principal Investigators
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Jean jacques SOTTO, MD
Role: PRINCIPAL_INVESTIGATOR
GOELAMS/BGMT
Arnaud PIGNEUX, MS
Role: PRINCIPAL_INVESTIGATOR
GOELAMS/BGMT
Francis WITZ, MS
Role: PRINCIPAL_INVESTIGATOR
French Innovative Leukemia Organisation
Locations
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Arnaud PIGNEUX
Pessac, , France
Countries
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References
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Pigneux A, Bene MC, Guardiola P, Recher C, Hamel JF, Sauvezie M, Harousseau JL, Tournilhac O, Witz F, Berthou C, Escoffre-Barbe M, Guyotat D, Fegueux N, Himberlin C, Hunault M, Delain M, Lioure B, Jourdan E, Bauduer F, Dreyfus F, Cahn JY, Sotto JJ, Ifrah N. Addition of Androgens Improves Survival in Elderly Patients With Acute Myeloid Leukemia: A GOELAMS Study. J Clin Oncol. 2017 Feb;35(4):387-393. doi: 10.1200/JCO.2016.67.6213. Epub 2016 Oct 24.
Other Identifiers
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LAM SA 2002
Identifier Type: -
Identifier Source: org_study_id