Detection of Residual Disease in Children Receiving Therapy for Acute Myeloid Leukemia or Myelodysplastic Syndrome
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|ClinicalTrials.gov Identifier: NCT00003790|
Recruitment Status : Completed
First Posted : April 23, 2004
Last Update Posted : August 6, 2014
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.
|Condition or disease||Intervention/treatment|
|Leukemia Myelodysplastic Syndromes||Genetic: polymerase chain reaction Other: flow cytometry|
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.
|Study Type :||Observational|
|Actual Enrollment :||496 participants|
|Official Title:||Detection of Minimal Residual Disease in Children Receiving Therapy for AML or MDS|
|Study Start Date :||February 1995|
|Primary Completion Date :||April 2002|
|Study Completion Date :||September 2006|
- Determine the frequency and prognostic significance of persistent abnormal cells with an aberrant phenotype detected by MDF in bone marrow samples from patients who have achieved clinical remission. [ Time Frame: 12 months from achievement of remission ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003790
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|Study Chair:||Eric Sievers, MD||Fred Hutchinson Cancer Research Center|