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Clinical Trials/NCT00003790
NCT00003790
Completed
Not Applicable

Detection of Minimal Residual Disease in Children Receiving Therapy for AML or MDS

Children's Oncology Group43 sites in 3 countries496 target enrollmentFebruary 1995

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Leukemia
Sponsor
Children's Oncology Group
Enrollment
496
Locations
43
Primary Endpoint
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.
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
February 1995
End Date
September 2006
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Study Sites (43)

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