Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Children With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
Childhood Acute Erythroleukemia (M6), Childhood Acute Megakaryocytic Leukemia (M7), Childhood Acute Monoblastic Leukemia (M5a)
About this trial
This is an interventional treatment trial for Childhood Acute Erythroleukemia (M6)
Eligibility 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
Sites / Locations
- Children's Oncology Group
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Active Comparator
Experimental
Arm I (combination chemotherapy)
Arm II (combination chemotherapy)
Arm III (combination chemotherapy, aldesleukin)
Arm IV (combination chemotherapy)
Arm V (combination chemotherapy, radiotherapy)
Patients receive treatment as in induction therapy, plus G-CSF SC beginning on day 16 and continuing until blood counts recover. If CSF is clear by day 10 of induction, patients receive cytarabine IT on days 0, 10, and 35. If CSF is not clear, patients receive triple intrathecal therapy (TIT; cytarabine, hydrocortisone, methotrexate) on days 0 and 10. See Detailed Description
Patients receive fludarabine IV over 24 hours on days 0 and 1, cytarabine IV over 72 hours on days 2-4, and idarubicin IV over 15 minutes on days 0-2. G-CSF begins on day 6 and continues until blood counts recover. Patients also receive TIT on days -1 and 7, if CSF is not clear on day 10 of induction. Patients on both arms are reassessed on day 35. Those patients with M1 marrow proceed to intensification; all others are removed from the study. Intensification: See Detailed Description
Patients receive interleukin-2 IV continuously on days 1-4 and 9-18.
No further treatment
Patients undergo radiotherapy to the chloroma 5 days a week for 2 weeks.