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

• Status: Completed
• Trial end date: 1969-12-31
• 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. Combining more than one drug may kill more cancer cells. It is not yet known which regimen of combination chemotherapy is more effective for acute myeloid leukemia or myelodysplastic syndrome.

PURPOSE: Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens in treating children who have newly diagnosed acute myeloid leukemia or myelodysplastic syndrome.

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

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Treatments: Cytarabine; Daunorubicin; Dexamethasone; Etoposide; Idarubicin; Mitoxantrone; Thioguanine

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