Phase I Study in RAD 001 Patients With Relapse AML

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase ITreatmentCompleted18 to 65OtherRAD 001

Trial Description


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 Contact Information

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 record.
NLM Identifier NCT01074086 processed this data on October 20, 2014

Note: Information about this trial is from the database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the record to standardize the names of study sponsors, sites, and contacts. only lists sites that are recruiting patients for active trials, whereas lists all sites for all trials. Questions and comments regarding the presented information should be directed to