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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00544999

Enrollment

Registered

2007-10-16

Start date

2007-09-30

Completion date

Unknown

Last updated

2013-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia

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)

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.

Detailed description

OBJECTIVES: Primary * Determine the maximum tolerated dose of everolimus. * Determine the toxicity of this regimen. Secondary * 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.

Interventions

DRUGcytarabine

DRUGdaunorubicin hydrochloride

DRUGeverolimus

OTHERlaboratory biomarker analysis

OTHERpharmacological study

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

DISEASE CHARACTERISTICS: 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 PATIENT CHARACTERISTICS: 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

Design outcomes

Primary

Measure	Time frame
Maximum tolerated dose of everolimus	—
Toxicity	—

Secondary

Measure	Time frame
Activation of PI3K/AKT and mTORC 1 in leukemic blasts	—
Pharmacokinetics of everolimus	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026