Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome

Launched by EUROPEAN ORGANISATION FOR RESEARCH AND TREATMENT OF CANCER - EORTC · Jan 26, 2003

Keywords

ClinConnect Summary

OBJECTIVES:

* Compare the efficacy of idarubicin vs mitoxantrone in induction and first intensification in terms of achieving and maintaining complete remissions in children with acute myeloid leukemia or myelodysplastic syndrome.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center and disease type (de novo acute myeloid leukemia (AML) vs AML secondary to myelodysplastic syndrome (MDS) vs MDS).

* Induction: Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive cytarabine (ARA-C) IV continuously on days 1 and 2 and then IV...

Gender

ALL

Eligibility criteria

• DISEASE CHARACTERISTICS:
• • Newly diagnosed acute myeloid leukemia (AML) based on the cytological, cytochemical, and immunological criteria of the FAB classification
• * Must meet 1 of the following criteria:
• • More than 30% blasts in marrow (calculation based on the total number of nucleated cells except lymphocytes and plasmocytes)
• • Presence of granulocytic sarcoma (chloroma)
• * Disease must be associated with at least 1 of the following:
• • More than 3% myeloperoxidase- or Sudan black-positive blasts
• • More than 3% platelet peroxidase-positive blasts
• • More than 20% esterase-positive blasts
• * Immunological markers compatible with a myeloid differentiation, including 1 of the following criteria:
• • Blasts positive for myeloid-associated antigen and negative for B- or T-lymphocyte antigens
• • Blasts positive for at least 2 myeloid antigens (except CD3 and CD8)
• • A cytogenetic abnormality associated with AML OR
• • Newly diagnosed myelodysplastic syndrome (MDS) based on the cytological and cytochemical criteria of the FAB classification
• * Eligible subtypes:
• • Refractory anemia with excess blasts (RAEB)
• • RAEB in transformation
• • Chronic myelomonocytic leukemia
• • No promyelocytic leukemia (M3 or M3v) treated with tretinoin (protocol EORTC-06915)
• • No AML secondary to hematologic or malignant disease other than MDS
• • Registration must occur within 48 hours of diagnosis
• PATIENT CHARACTERISTICS:
• Age:
• • Under 15
• Performance status:
• • Not specified
• Life expectancy:
• • Not specified
• Hematopoietic:
• • See Disease Characteristics
• • No uncontrolled bleeding disorder
• Hepatic:
• • Not specified
• Renal:
• • No renal failure
• Cardiovascular:
• • No congenital heart disease
• Other:
• • No encephalopathy
• • No genetic disorders
• • No uncontrolled infection
• PRIOR CONCURRENT THERAPY:
• Biologic therapy:
• • Not specified
• Chemotherapy:
• • Not specified
• Endocrine therapy:
• • Not specified
• Radiotherapy:
• • Not specified
• Surgery:
• • Not specified
• Other:
• • No prior antileukemic therapy

Trial Officials