Clofarabine, Cytarabine, and Idarubicin in Treating Patients With Intermediate-Risk or High-Risk Acute Myeloid Leukemia or High-Risk Myelodysplasia

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of clofarabine and to see how well it works when given together with cytarabine and idarubicin in treating patients with intermediate-risk or high-risk acute myeloid leukemia or high-risk myelodysplasia.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Collaborator: Gruppo Italiano Malattie EMatologiche dell'Adulto
• Treatments: Clofarabine; Cytarabine; Idarubicin

Criteria

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)