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
PHASE1
31 participants
INTERVENTIONAL
2008-02-29
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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FACTORIAL
TREATMENT
NONE
Study Groups
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RAD 001
RAD 001 in day 1 and day 7 from 10 mg to 50 mg
RAD 001
RAD 001 in steps of 3 patients from 10mg in day 1 and day 7 to 50 mg
Interventions
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RAD 001
RAD 001 in steps of 3 patients from 10mg in day 1 and day 7 to 50 mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* AML in relapse more than 1 year after CR
* inform consent signed
Exclusion Criteria
* cardiac insufficiency
* renal insufficiency
* hepatic disease
* other type of AML
* blastic MCL
* HIV positive serology
* other malignancy
* pulmonary infection
18 Years
65 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
French Innovative Leukemia Organisation
OTHER
Responsible Party
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Principal Investigators
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Sophie PARK, MD MS
Role: PRINCIPAL_INVESTIGATOR
French Innovative Leukemia Organisation
Didier BOUSCArY, MD MS
Role: PRINCIPAL_INVESTIGATOR
French Innovative Leukemia Organisation
Locations
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Sophie Park
Paris, , France
Countries
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References
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Park S, Chapuis N, Saint Marcoux F, Recher C, Prebet T, Chevallier P, Cahn JY, Leguay T, Bories P, Witz F, Lamy T, Mayeux P, Lacombe C, Demur C, Tamburini J, Merlat A, Delepine R, Vey N, Dreyfus F, Bene MC, Ifrah N, Bouscary D; GOELAMS (Groupe Ouest Est d'Etude des Leucemies aigues et Autres Maladies du Sang). A phase Ib GOELAMS study of the mTOR inhibitor RAD001 in association with chemotherapy for AML patients in first relapse. Leukemia. 2013 Jul;27(7):1479-86. doi: 10.1038/leu.2013.17. Epub 2013 Jan 16.
Other Identifiers
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RAD 001
Identifier Type: -
Identifier Source: org_study_id