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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 17 October 2012
Main ID:  NCT00235560
Date of registration: 09/09/2005
Primary sponsor: University Hospital, Toulouse
Public title: Rapamycin in Combination With Low-Dose Aracytin in Elderly Acute Myeloid Leukemia Patients LAM-RAPA
Scientific 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)
Date of first enrolment: June 2005
Target sample size: 50
Recruitment status: Completed
Study type:  Interventional
Study design:  Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Countries of recruitment
Key inclusion & exclusion criteria

Inclusion Criteria:

- Age > 60 y.

- Informed consent

- de novo or secondary LAM(CML excluded) not elligible for intensive chemotherapy.

- Previously untreated

Exclusion Criteria:

- Renal impairment (serum creatinin >2N)

- Hepatic impairment (TGO ou TGP > 5N), une cholestase (Phosphatases Alcalines or
gamma-GT > 5N),bilirubin > 3N

- Blast crisis CML

- Acute Promyelocytic Leukemia

Age minimum: 60 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Acute Myeloid Leukemia
Drug: rapamycin
Primary Outcome(s)
response rate [Time Frame: Yes]
Secondary Outcome(s)
bioclinical markers of response [Time Frame: No]
tolerability [Time Frame: Yes]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
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