Everolimus MICE-regimen in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia (AML1208)
Leukemia
About this trial
This is an interventional treatment trial for Leukemia focused on measuring secondary acute myeloid leukemia, untreated adult acute myeloid leukemia, adult acute basophilic leukemia, adult acute eosinophilic leukemia, adult erythroleukemia (M6a), adult pure erythroid leukemia (M6b), adult acute megakaryoblastic leukemia (M7), adult acute minimally differentiated myeloid leukemia (M0), adult acute monoblastic leukemia (M5a), adult acute monocytic leukemia (M5b), adult acute myeloblastic leukemia with maturation (M2), adult acute myeloblastic leukemia without maturation (M1), adult acute myelomonocytic leukemia (M4), 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)
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Newly diagnosed acute myeloid leukemia (AML) (unequivocal) according to WHO diagnostic criteria (at least 20% blasts in the bone marrow), with FAB classification other than M3 (acute promyelocytic leukemia), and documented by bone marrow aspiration (or biopsy in case of dry tap)
- Previously untreated primary or secondary AML (including AML following antecedent myelodysplasia)
- No blast transformation of chronic myeloid leukemia or other myeloproliferative disorders
- No active CNS leukemia
PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- Total serum bilirubin < 2 times upper limit of normal (ULN)
- Serum creatinine < 2 times ULN
- ALT/AST ≤ 3 times ULN (unless due to organ leukemic involvement)
- LVEF ≥ 50% by echocardiogram
- No other concurrent active malignancy
- No active uncontrolled infection
- No known active hepatitis B or C or HIV positivity
- No active heart disease including myocardial infarction within the past 3 months, symptomatic coronary artery disease, cardiac arrhythmias not controlled by medications, or uncontrolled congestive heart failure
- No medical condition that, in the opinion of the investigator, places the patient at an unacceptably high risk for toxicities
- No other known condition (e.g., familial, sociological, or geographical) or behavior (including drug dependence or abuse, psychological or psychiatric illness) that, in the opinion of the investigator, would make the patient a poor candidate for the trial
- No known hypersensitivity to everolimus, other rapamycins (e.g., sirolimus or temsirolimus), or to its excipients
PRIOR CONCURRENT THERAPY:
No prior standard or investigational chemotherapy for acute myeloid leukemia or myelodysplasia (including everolimus or other mTOR inhibitors)
- Prior hydroxyurea allowed (up to a maximum of 14 days) to control peripheral blood leukemic cell counts
- No prior enrollment in this trial
- No other concurrent anti-leukemia agents, investigational agents, or biological agents
Sites / Locations
- Ematologia con trapianto- AOU Policlinico Consorziale di Bari
- Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia
- Università La Sapienza
- Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia
- Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Arms of the Study
Arm 1
Experimental
Everolimus
Everolimus mice-regimen