Leukemia Clinical Trial
Official title:
Detection of Minimal Residual Disease in Children Receiving Therapy for AML or MDS
RATIONALE: Diagnostic procedures may improve the ability to detect residual disease.
PURPOSE: Clinical trial to detect the presence of residual disease in children who are
receiving therapy for acute myeloid leukemia or myelodysplastic syndrome.
OBJECTIVES: I. Determine the frequency and prognostic significance of persistent abnormal
cells with an aberrant phenotype detected by multidimensional flow cytometry (MDF) in bone
marrow samples from children who have achieved clinical remission after receiving treatment
for acute myeloid leukemia or myelodysplastic syndrome. II. Compare the frequency of
persistent abnormal cells obtained by MDF with that of polymerase chain reaction (PCR),
morphologic, and cytogenetic analyses of these patient samples. III. Determine the frequency
and prognostic significance of persistent abnormal cells with a leukemia-specific molecular
marker detected by PCR in samples from these patients.
OUTLINE: Patients have bone marrow samples collected during the course of therapy on the CCG
2961 acute myeloid leukemia treatment protocol. These samples are collected: 1. At the time
of diagnosis 2. At the end of induction (within a week of day 35) 3. At the end of
consolidation (before bone marrow transplant or Capizzi 2) 4. Before and after interleukin-2
(IL-2) therapy, if applicable 5. At the end of therapy (after transplant with evidence of
engraftment for autologous bone marrow transplant patients; after course 2 of
intensification for chemotherapy patients; and after IL-2 day 21 for IL-2 patients) 6. At
relapse, if applicable. The presence of minimal residual disease in bone marrow is assessed
using multidimensional flow cytometry and PCR.
PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.
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