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

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. Identifier: NCT00544999
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : October 16, 2007
Last Update Posted : September 17, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Leukemia Drug: cytarabine Drug: daunorubicin hydrochloride Drug: everolimus Other: laboratory biomarker analysis Other: pharmacological study Phase 1

Detailed Description:



  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Primary Purpose: Treatment
Official Title: Phase I Study Evaluating the Chemosensitizing Effect of Everolimus Administered With Cytarabine and Daunorubicin in Patients With Acute Myeloid Leukemia in Relapse
Study Start Date : September 2007
Estimated Primary Completion Date : April 2010

Primary Outcome Measures :
  1. Maximum tolerated dose of everolimus
  2. Toxicity

Secondary Outcome Measures :
  1. Activation of PI3K/AKT and mTORC 1 in leukemic blasts
  2. Pharmacokinetics of everolimus

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00544999

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Hopital Cochin Recruiting
Paris, France, 75674
Contact: Sophie Park, MD    33-140-514-543      
Sponsors and Collaborators
Institut de Recherche Clinique sur les Cancers et le Sang
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OverallOfficial: Sophie Park, MD Institut de Recherche Clinique sur les Cancers et le Sang
Layout table for additonal information Identifier: NCT00544999    
Other Study ID Numbers: CDR0000564068
First Posted: October 16, 2007    Key Record Dates
Last Update Posted: September 17, 2013
Last Verified: July 2009
Keywords provided by National Cancer Institute (NCI):
recurrent adult acute myeloid leukemia
secondary acute myeloid leukemia
adult acute minimally differentiated myeloid leukemia (M0)
adult acute myeloblastic leukemia without maturation (M1)
adult acute myeloblastic leukemia with maturation (M2)
adult acute myelomonocytic leukemia (M4)
adult acute monoblastic leukemia (M5a)
adult acute monocytic leukemia (M5b)
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors