Status:
UNKNOWN
Clofarabine, Cytarabine, and Idarubicin in Treating Patients With Intermediate-Risk or High-Risk Acute Myeloid Leukemia or High-Risk Myelodysplasia
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Collaborating Sponsors:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Conditions:
Leukemia
Myelodysplastic Syndromes
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as clofarabine, cytarabine, and idarubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from ...
Detailed Description
OBJECTIVES: Primary * To determine the optimum dose of clofarabine in combination with cytarabine and idarubicin in patients with previously untreated intermediate- and high-risk acute myeloid leuke...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of 1 of the following by WHO criteria:
- Acute myeloid leukemia (AML) (≥ 20% bone marrow blasts by bone marrow aspiration or biopsy)
- No acute promyelocytic leukemia (M3)
- All cytogenetic groups allowed, except for the following:
- t(15;17)
- t(8;21) or inv(16) AND a WBC count at diagnosis of \< 100,000/μL
- Primary or secondary AML allowed, including AML after myelodysplasia (MDS)
- High-risk MDS (≥ 10% bone marrow blasts by bone marrow aspiration or biopsy)
- No chronic myelogenous leukemia in blast crisis or AML supervening a myeloproliferative disorder
- Previously untreated disease, except for ≤ 14 days of hydroxyurea
- No CNS leukemia
- PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- Serum creatinine ≤ 1.0 mg/dL or glomerular filtration rate \> 60 mL/min
- AST/ALT ≤ 2.5 times upper limit of normal (ULN)
- ALP ≤ 2.5 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception during and for ≥ 3 months after completion of study treatment
- No active uncontrolled infection
- No HIV positivity
- No psychological, familial, sociological, or geographical conditions precluding compliance with study treatment or follow up
- No concurrent severe uncontrolled cardiovascular disease (i.e., symptomatic congestive heart failure or symptomatic ischemic heart disease \[NYHA class III-IV\])
- No concurrent malignant disease
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No concurrent cytotoxic drugs or experimental therapies (e.g., antiangiogenic drugs, tyrosine kinase inhibitors)
Exclusion
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT00838240
Start Date
November 1 2008
Last Update
July 20 2012
Active Locations (10)
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1
A.Z. Sint-Jan
Bruges, Belgium
2
Institut Jules Bordet
Brussels, Belgium
3
CHU Sart-Tilman
Liège, Belgium
4
University Hospital Rebro
Zagreb, Croatia