Status:
COMPLETED
Laromustine, Daunorubicin, and Cytarabine in Treating Patients With Acute Myeloid Leukemia
Lead Sponsor:
Institut Paoli-Calmettes
Conditions:
Leukemia
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as laromustine, daunorubicin, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them fro...
Detailed Description
OBJECTIVES: Primary * To determine the dose of laromustine that can be combined with daunorubicin hydrochloride and cytarabine in patients with previously untreated acute myeloid leukemia with unfav...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of acute myeloid leukemia (AML)
- Untreated disease
- No promyelocytic AML
- Unfavorable prognosis, defined as at least one of the following:
- Cytogenetic abnormalities including -5/5q-, -7/7q-, 3q, 11q23, t(6;9), and complex abnormalities (≥ 3 clonal abnormalities), excluding t(9;11)
- Baseline hyperleukocytosis ≥ 100 g/L or progression of leukocytosis or extra-medullary localizations despite treatment with hydroxyurea
- No AML with favorable or intermediate prognosis
- No AML secondary to myelodysplastic syndrome diagnosed within the past 3 months or myeloproliferative syndrome
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Total bilirubin \< 35 μmol/L
- Transaminases \< 2.5 times upper limit of normal in the absence of leukemia-related abnormalities
- Creatinine \< 170 μmol/L OR creatinine clearance ≥ 50 mL/min in the absence of leukemia-related abnormalities
- Not pregnant or nursing
- Normal cardiac function by LVEF (echographic ≥ 40% or isotopic ≥ 50%)
- Affiliated with a social security system
- No uncontrolled or severe cardiovascular disease, including any of the following:
- Myocardial infarction within the past 3 months
- Cardiac insufficiency
- Uncontrolled arrhythmia
- No other active cancer within the past year except for basal cell carcinoma of the skin or epithelioma in situ of the cervix
- No patients deprived of freedom or under guardianship (including temporary guardianship)
- No psychological, familial, geographical, or social situations that preclude follow-up
- No other contraindications to study treatment
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Prior hydroxyurea allowed
- No concurrent disulfiram
- No concurrent participation in another study with an experimental drug
Exclusion
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT00840684
Start Date
January 1 2009
Last Update
May 13 2011
Active Locations (1)
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1
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, France, 13273