Idarubicin, Cytarabine, and Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated High-Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia Secondary to Myelodysplastic Syndrome

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

Summary

RATIONALE: Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as gemtuzumab ozogamicin, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Giving monoclonal antibody therapy together with chemotherapy may kill more cancer cells. Giving healthy stem cells from a donor whose blood closely resembles the patient's blood will help the patient's bone marrow make new stem cells that become red blood cells, white blood cells, and platelets.

PURPOSE: This phase II trial is studying how well giving idarubicin and cytarabine together with gemtuzumab ozogamicin works in treating patients with previously untreated high-risk myelodysplastic syndrome or acute myeloid leukemia secondary to myelodysplastic syndrome.

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

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Treatments: Busulfan; Cyclophosphamide; Cytarabine; Gemtuzumab; Idarubicin

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed diagnosis of 1 of the following:

• High-risk myelodysplastic syndromes (MDS), including any of the following:

• Refractory anemia with excess blasts (RAEB) with > 10% blast cells in the bone marrow

• RAEB in transformation

• Other forms of MDS with multiple (3 or more) chromosomal abnormalities or chromosome 7 abnormalities AND/OR profound cytopenias, defined as neutrophil count < 500/mm^3 and/or platelet count < 20,000/mm^3

• Chronic myelomonocytic leukemia with > 5% blast cells in the bone marrow

• Chronic myelomonocytic leukemia with neutrophil count > 16,000/mm^3 OR monocyte count > 2,600/mm^3

• Secondary acute myeloid leukemia supervening after overt MDS of more than 6 months in duration

• Patients with or without an HLA-identical sibling

• No active CNS leukemia

PATIENT CHARACTERISTICS:

Age

• 16 to 70

Performance status

• WHO 0-2

Life expectancy

• Not specified

Hematopoietic

• See Disease Characteristics

Hepatic

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)

Renal

• Creatinine ≤ 1.5 times ULN

Cardiovascular

• No severe cardiovascular disease

• No arrhythmias requiring chronic treatment

• No congestive heart failure

• No symptomatic ischemic heart disease

Pulmonary

• No severe lung disease

Other

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No HIV positivity

• No other concurrent malignant disease

• No active uncontrolled infection

• No history of alcohol abuse (i.e., averaged less than 5 alcoholic consumptions daily for the past year)

• No concurrent severe neurological or psychiatric disease

• No other psychological, familial, sociological, or geographical condition that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

• More than 6 weeks since prior growth factors

Chemotherapy

• No prior intensive chemotherapy

• More than 6 weeks since prior low-dose chemotherapy or hydroxyurea

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• More than 6 weeks since prior immunosuppressants

• No prior participation in this clinical study