Basic Trial Information
Trial Description
Summary
Further Trial Information
Eligibility Criteria
Trial Contact Information
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase I | Treatment | Completed | 18 to 65 | Other | RAD 001 NCT01074086 |
Summary
A phase I clinical study in evaluation of RAD 001 with aracytine and daunorubicine in AML treatment of patients older less than 65 years in relapse
Further Study Information
The primary objective of the study is to determinate the maximal tolerate dose and evaluate the toxicity of RAD 001 in patients older less than 65 years in AML relapse in association with a conventional chemotherapy 5Aracytine and Daunorubicine) in an dose escalated phase I study.
Eligibility Criteria
Inclusion Criteria:
- patients from 18 to 65 years old
- AML in relapse more than 1 year after CR
- inform consent signed
Exclusion Criteria:
- age more than 65
- cardiac insufficiency
- renal insufficiency
- hepatic disease
- other type of AML
- blastic MCL
- HIV positive serology
- other malignancy
- pulmonary infection
Trial Lead Organizations/Sponsors
Groupe Ouest Est d'etude des Leucemies et Autres Maladies du Sang
Novartis Pharmaceuticals Corporation| Sophie Park | ![]() | Principal Investigator |
| Didier BOUSCArY, MD MS | ![]() | Principal Investigator |
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01074086
Information obtained from ClinicalTrials.gov on December 23, 2012
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