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Tracking Information | |||||
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First Received Date † | September 9, 2005 | ||||
Last Updated Date | June 19, 2008 | ||||
Start Date † | June 2005 | ||||
Current Primary Outcome Measures † |
response rate [ Designated as safety issue: Yes ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00235560 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † |
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Descriptive Information | |||||
Brief Title † | Rapamycin in Combination With Low-Dose Aracytin in Elderly Acute Myeloid Leukemia Patients | ||||
Official Title † | Rapamycin in Combination With Low-Dose Aracytin in Elderly Acute Myeloid Leukemia Patients. A Study From the Groupe Ouest Est d'étude Des Leucémies Aiguës Myéloïdes (GOELAMS) | ||||
Brief Summary | These study is designed to evaluate the tolerability and efficacy of sirolimus (rapamycin) in combination with low-dose aracytin in elderly AML. |
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Detailed Description | Evaluate the tolerability and efficacy of sirolimus (rapamycin) in combination with low-dose aracytin |
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Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||
Condition † | Acute Myeloid Leukemia | ||||
Intervention † | Drug: rapamycin | ||||
Study Arms / Comparison Groups | |||||
Publications * | Recher C, Beyne-Rauzy O, Demur C, Chicanne G, Dos Santos C, Mas VM, Benzaquen D, Laurent G, Huguet F, Payrastre B. Antileukemic activity of rapamycin in acute myeloid leukemia. Blood. 2005 Mar 15;105(6):2527-34. Epub 2004 Nov 18. | ||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 50 | ||||
Completion Date | June 2008 | ||||
Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 60 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | France | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00235560 | ||||
Responsible Party | LLAU Marie-Elise, University Hospital Toulouse | ||||
Secondary IDs †† | GOELAMS, PHRC | ||||
Study Sponsor † | University Hospital, Toulouse | ||||
Collaborators †† | Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS | ||||
Investigators † |
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Information Provided By | University Hospital, Toulouse | ||||
Verification Date | June 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |