Status:
COMPLETED
Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Children With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Childhood Acute Erythroleukemia (M6)
Childhood Acute Megakaryocytic Leukemia (M7)
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE3
Brief 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 myelo...
Detailed Description
OBJECTIVES: Increase the remission induction rate to greater than 85% in children with untreated acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) by replacing daunorubicin (DNR) wi...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 1996
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
880 Patients enrolled
Trial Details
Trial ID
NCT00002798
Start Date
August 1 1996
Last Update
January 16 2013
Active Locations (1)
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1
Children's Oncology Group
Arcadia, California, United States, 91006-3776