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Main
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Note: This record shows only 22 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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 March 2024 |
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Main ID: |
NCT00235560 |
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Date of registration:
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09/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Rapamycin in Combination With Low-dose Aracytin in Elderly Acute Myeloid Leukemia Patients
LAM-RAPA |
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Scientific title:
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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) |
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Date of first enrolment:
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June 2005 |
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Target sample size:
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50 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT00235560 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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France
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Contacts
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Name:
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RECHER Christian |
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Address:
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Telephone:
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Email:
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Affiliation:
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CHU Toulouse |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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:
All
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Health Condition(s) or Problem(s) studied
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Acute Myeloid Leukemia
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Intervention(s)
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Drug: rapamycin
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Primary Outcome(s)
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response rate
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Secondary Outcome(s)
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bioclinical markers of response
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tolerability
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Secondary ID(s)
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0402008
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PHRC
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GOELAMS
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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