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Everolimus, Cytarabine, and Daunorubicin in Treating Patients With Relapsed Acute Myeloid Leukemia

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
ClinicalTrials.gov Identifier:
First Posted: October 16, 2007
Last Update Posted: September 17, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
October 13, 2007
October 16, 2007
September 17, 2013
September 2007
April 2010   (Final data collection date for primary outcome measure)
  • Maximum tolerated dose of everolimus
  • Toxicity
Same as current
Complete list of historical versions of study NCT00544999 on ClinicalTrials.gov Archive Site
  • Activation of PI3K/AKT and mTORC 1 in leukemic blasts
  • Pharmacokinetics of everolimus
Same as current
Not Provided
Not Provided
Everolimus, Cytarabine, and Daunorubicin in Treating Patients With Relapsed Acute Myeloid Leukemia
Phase I Study Evaluating the Chemosensitizing Effect of Everolimus Administered With Cytarabine and Daunorubicin in Patients With Acute Myeloid Leukemia in Relapse

RATIONALE: Drugs used in chemotherapy, such as cytarabine and daunorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Everolimus may help cytarabine and daunorubicin work better by making cancer cells more sensitive to chemotherapy. Giving everolimus together with cytarabine and daunorubicin may kill more cancer cells.

PURPOSE: This phase I trial is studying the side effects and best dose of everolimus when given together with cytarabine and daunorubicin in treating patients with relapsed acute myeloid leukemia.



  • Determine the maximum tolerated dose of everolimus.
  • Determine the toxicity of this regimen.


  • Assess the activation of PI3K/AKT and mTORC 1 in leukemic blasts.
  • Evaluate the pharmacokinetics of everolimus at different concentrations.

OUTLINE: This is a multicenter study.

Patients receive primary induction therapy comprising daunorubicin hydrochloride IV on days 1-3, cytarabine IV over 24 hours on day 1, and oral everolimus on days 1 and 7. Patients with more than 5% blasts on day 15 receive a second induction course comprising daunorubicin hydrochloride IV on days 17 and 18 and cytarabine IV twice daily on days 17-20.

After completion of study therapy, patients are followed for 3 months.

Phase 1
Primary Purpose: Treatment
  • Drug: cytarabine
  • Drug: daunorubicin hydrochloride
  • Drug: everolimus
  • Other: laboratory biomarker analysis
  • Other: pharmacological study
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Unknown status
Not Provided
April 2010   (Final data collection date for primary outcome measure)


Inclusion criteria:

  • Diagnosis of de novo or secondary acute myeloid leukemia meeting the following criterion:

    • Relapse > 1 year after obtaining complete remission (any prior treatment allowed)

Exclusion criteria:

  • Philadelphia chromosome-positive disease in blast crisis
  • FAB M3, M6, or M7 disease


Inclusion criteria:

  • Life expectancy ≥ 4 weeks
  • Transaminases ≤ 5 times normal
  • Creatinine ≤ 2 times normal
  • Bilirubin ≤ 3 times normal (except if visceral involvement present)
  • Alkaline phosphatase or gamma-glutamyltransferase ≤ 5 times normal
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients of must use effective contraception during and for ≥ 28 days after completion of study therapy

Exclusion criteria:

  • FEV1 < 30%
  • Active uncontrolled or viral pulmonary infection
  • Serious psychiatric disorders not related to leukemia or any condition that would prohibit comprehension of the study
  • HIV-positive
  • Other concurrent malignancy except noninvasive skin cancer or carcinoma in situ
  • Patients who are incarcerated or under supervision or trusteeship


Inclusion criteria:

  • See Disease Characteristics

Exclusion criteria:

  • Prior experimental medication within the past 4 weeks
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Not Provided
Not Provided
Institut de Recherche Clinique sur les Cancers et le Sang
Not Provided
Investigator: Sophie Park, MD Institut de Recherche Clinique sur les Cancers et le Sang
National Cancer Institute (NCI)
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP