Chemotherapy With or Without Gemtuzumab Ozogamicin in Treating Older Patients With Acute Myeloid Leukemia

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known if combining combination chemotherapy with monoclonal antibody therapy will kill more cancer cells.

PURPOSE: Randomized phase III trial to determine the effectiveness of combination chemotherapy with or without gemtuzumab ozogamicin in treating patients who have acute myeloid leukemia.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of acute myeloid leukemia (AML)

• Bone marrow blasts at least 20% by bone marrow aspiration or biopsy

• FAB subtypes M0-M2 and M4-M7

• No acute promyelocytic leukemia (FAB subtype M3)

• Previously untreated primary or secondary AML, including AML after myelodysplastic syndromes

• Hydroxyurea and/or corticosteroid therapy for no more than 14 days allowed

• No blast crisis of chronic myelogenous leukemia

• No AML supervening after other myeloproliferative diseases

• No active CNS leukemia

PATIENT CHARACTERISTICS:

Age

• 61 to 75

Performance status

• WHO 0-2

Life expectancy

• Not specified

Hematopoietic

• WBC less than 30,000/mm^3 (pretreatment with hydroxyurea for no more than 14 days allowed)

Hepatic

• Bilirubin no greater than 3 times upper limit of normal (ULN)

Renal

• Creatinine no greater than 3 times ULN

Cardiovascular

• No concurrent severe cardiovascular disease

• No arrhythmias requiring chronic treatment

• No congestive heart failure

• No symptomatic ischemic heart disease

Pulmonary

• No severe pulmonary dysfunction (CTC grade 3-4)

Other

• HIV negative

• No other uncontrolled infection

• No other concurrent malignant disease

• No severe concurrent neurological or psychiatric disease

• No prior alcohol abuse

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent hematopoietic growth factors (filgrastim [G-CSF] or sargramostim [GM-CSF]) except for life-threatening infection due to neutropenia

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• See Disease Characteristics

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• No prior enrollment in this trial