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)
Phase 2
60 Years
N/A
60 Years
N/A
Not Enrolling
Both
Acute Myeloid Leukemia
Both
Acute Myeloid Leukemia
Trial Information
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)
Evaluate the tolerability and efficacy of sirolimus (rapamycin) in combination with low-dose
aracytin
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
response rate
Safety Issue:
Yes
Principal Investigator
RECHER Christian
Investigator Role:
Principal Investigator
Investigator Affiliation:
CHU Toulouse
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
0402008
NCT ID:
NCT00235560
Start Date:
June 2005
Completion Date:
June 2008
Related Keywords:
- Acute Myeloid Leukemia
- AML
- Rapamycin
- Elderly
- Elderly patients not eligible for intensive chemotherapy
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
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