Status:
COMPLETED
Everolimus MICE-regimen in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia
Lead Sponsor:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Conditions:
Leukemia
Eligibility:
All Genders
61-75 years
Phase:
PHASE1
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as mitoxantrone hydrochloride, cytarabine, etoposide, and idarubicin, work in different ways to stop the growth of cancer cells, either by killing the cells...
Detailed Description
OBJECTIVES: Primary * To determine the maximum-tolerated dose of everolimus in combination with standard remission-induction therapy comprising mitoxantrone hydrochloride, cytarabine, and etoposide ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2015
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT01154439
Start Date
October 1 2010
End Date
September 15 2015
Last Update
October 26 2022
Active Locations (5)
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1
Ematologia con trapianto- AOU Policlinico Consorziale di Bari
Bari, Italy
2
Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia
Napoli, Italy
3
Università La Sapienza
Roma, Italy, 00100
4
Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia
Roma, Italy