Cytarabine and Daunorubicin With or Without Gemtuzumab Ozogamicin in Treating Older Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as cytarabine and daunorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as gemtuzumab ozogamicin, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. It is not yet known whether cytarabine and daunorubicin followed by gemtuzumab ozogamicin is more effective than cytarabine and daunorubicin in treating acute myeloid leukemia or myelodysplastic syndromes.

PURPOSE: This randomized phase III trial is studying cytarabine and two different doses of daunorubicin to see how well they work compared to cytarabine and daunorubicin followed by gemtuzumab ozogamicin in treating older patients with acute myeloid leukemia or myelodysplastic syndromes.

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

Details

• Lead Sponsor: Stichting Hemato-Oncologie voor Volwassenen Nederland
• Treatments: Cytarabine; Daunorubicin; Gemtuzumab

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed diagnosis of 1 of the following:

• Acute myeloid leukemia (AML)

• M0-M2 or M4-M7 FAB subtype

• No AML with cytogenetic abnormality t(15;17) (M3)

• Patients with secondary AML progressing from prior myelodysplasia* or biphenotypic leukemia are eligible

• Refractory anemia with excess blasts (RAEB) or RAEB in transformation

• International Prognostic Scoring System score ≥ 1.5 NOTE: *Any prior hematological disease of ≥ 4 months duration

• No chronic myelogenous leukemia in blastic crisis

• No prior polycythemia rubra vera

• No primary myelofibrosis

PATIENT CHARACTERISTICS:

Age

• 61 and over

Performance status

• WHO 0-2

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• ALT and/or AST ≤ 2.5 times upper limit of normal (ULN)*

• Bilirubin ≤ 2 times ULN* NOTE: *Unless elevation is caused by organ infiltration by AML

Renal

• Creatinine ≤ 2 times ULN* NOTE: *Unless elevation is caused by organ infiltration by AML

Cardiovascular

• No myocardial infarction within the past 6 months

• LVEF > 50% by MUGA, echocardiogram, or other methods

• No unstable angina

• No unstable cardiac arrhythmia

• No severe and/or uncontrolled hypertension

Other

• No uncontrolled diabetes

• No severe and/or uncontrolled infection

• No other severe and/or uncontrolled medical condition

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• More than 6 months since prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• No prior induction therapy for AML or myelodysplastic syndromes