Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Children With Acute Myelogenous Leukemia or Myelodysplastic Syndrome

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

Summary

Randomized phase III trial to compare the effectiveness of different chemotherapy regimens with or without bone marrow transplantation in treating children who have acute myelogenous leukemia or myelodysplastic syndrome. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known which treatment regimen is more effective for acute myelogenous leukemia or myelodysplastic syndrome

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

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Aldesleukin; Asparaginase; Busulfan; Cortisol succinate; Cyclophosphamide; Cytarabine; Daunorubicin; Dexamethasone; Etoposide; Etoposide phosphate; Fludarabine; Fludarabine phosphate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Idarubicin; Interleukin-2; Methotrexate; Thioguanine

Criteria

Inclusion Criteria:

• Histologically confirmed previously untreated acute myeloid leukemia (AML) in patients 1 month to 21 years of age

• Infants under 1 month with progressive disease eligible

• Supportive care may be given to confirm that the leukemia is not regressing prior to entry

• No acute promyelocytic leukemia (FAB M3)

• No acute undifferentiated leukemia (FAB M0)

• Histochemical verification of AML required by the following stains:

• Wright or Giemsa

• Peroxidase

• PAS

• Chloroacetate esterase

• Sudan black

• Nonspecific esterase (NSE) with and without fluoride (NaF) inhibition

• Combined NSE/NaF and butyrate inhibition or diagnosis of megakaryoblasticleukemia (FAB M7) should be supported by one of the following:

• CD41 reactivity

• Glycoprotein 1b reactivity

• Factor VIII-related antigen reactivity

• Platelet peroxidase on electron microscopy

• The following are also eligible:

• Myelodysplastic syndromes, including:

• Refractory anemia (RA) *

• RA with ringed sideroblasts (RARS) *

• RA with excess blasts (RAEB)

• RAEB in transformation (RAEBt)

• Chronic myelomonocytic leukemia (CMML)

• AML with monosomy 7

• Granulocytic sarcoma (chloroma) with or without marrow involvement

• Mixed lineage leukemia with 2 morphologically defined populations provided the predominant population is myeloid

• No Downs syndrome

• No juvenile chronic myelogenous leukemia

• No Fanconi's anemia

• No secondary AML

• Performance status - Not specified

• No prior anticancer chemotherapy

• Prior topical or inhaled steroids for nonmalignant conditions allowed

• No prior anticancer radiotherapy

• No prior antileukemic therapy