Everolimus, Cytarabine, and Daunorubicin in Treating Patients With Relapsed Acute Myeloid Leukemia
Conditions: official terms
Leukemia - Leukemia, Myeloid - Leukemia, Myeloid, Acute
Conditions: Keywords
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)
Study Type
Study Phase
Phase 1
Study Design
Primary Purpose: Treatment
Name: cytarabine Type: Drug
Name: daunorubicin hydrochloride Type: Drug
Name: everolimus Type: Drug
Name: laboratory biomarker analysis Type: Other
Name: pharmacological study Type: Other
Overall Status
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 65 Years
Minimum Age: 18 Years
Gender: Both

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
Hopital Cochin
Paris, France
Status: Recruiting
Contact: Sophie Park, MD - 33-140-514-543
Start Date
September 2007
Institut de Recherches sur les Leucemies et les Maladies du Sang
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page