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Sponsors and Collaborators: |
University Hospital, Toulouse Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS |
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Information provided by: | University Hospital, Toulouse |
ClinicalTrials.gov Identifier: | NCT00235560 |
These study is designed to evaluate the tolerability and efficacy of sirolimus (rapamycin) in combination with low-dose aracytin in elderly AML.
Condition | Intervention | Phase |
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Acute Myeloid Leukemia |
Drug: rapamycin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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) |
Enrollment: | 50 |
Study Start Date: | June 2005 |
Study Completion Date: | June 2008 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Evaluate the tolerability and efficacy of sirolimus (rapamycin) in combination with low-dose aracytin
Ages Eligible for Study: | 60 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Hepatic impairment (TGO ou TGP > 5N), une cholestase (Phosphatases Alcalines or gamma-GT > 5N),bilirubin > 3N
France | |
Service d'Hématologie CHU Purpan | |
Toulouse, France, 31059 | |
Service d'Hématologie, CHU | |
ANGERS, France, 49100 | |
Service d'Hématologie, Hôpital Jean Minjoz | |
BESANçON, France, 25000 |
Principal Investigator: | RECHER Christian | CHU Toulouse |
Responsible Party: | University Hospital Toulouse ( LLAU Marie-Elise ) |
Study ID Numbers: | 0402008, GOELAMS, PHRC |
Study First Received: | September 9, 2005 |
Last Updated: | June 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00235560 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
AML Rapamycin Elderly Elderly patients not eligible for intensive chemotherapy |
Sirolimus Leukemia Clotrimazole Miconazole Tioconazole |
Acute myelogenous leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Acute myelocytic leukemia Cytarabine |
Anti-Bacterial Agents Anti-Infective Agents Neoplasms Neoplasms by Histologic Type Immunologic Factors Antineoplastic Agents |
Antifungal Agents Therapeutic Uses Physiological Effects of Drugs Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions |