Detection of Residual Disease in Children Receiving Therapy for Acute Myeloid Leukemia or Myelodysplastic Syndrome

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.

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Key information

Conditions

Leukemia Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Myelodysplastic Syndromes Neoplasms Neoplasms by Histologic Type

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Princess Margaret Hospital for Children, Perth, Western Australia, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS: Acute myeloid leukemia (AML) or myelodysplastic syndrome and enrolled on the CCG 2961 AML treatment protocol Must have one of the following cytogenetic abnormalities t(8;21) inv(16) abnormality of 11q23 OR All patients being enrolled for interleukin-2 therapy or standard care can be enrolled at the time of randomization

PATIENT CHARACTERISTICS: Age: Children Performance status: Specified on the CCG 2961 AML treatment protocol Life expectancy: Specified on the CCG 2961 AML treatment protocol Hematopoietic: Specified on the CCG 2961 AML treatment protocol Hepatic: Specified on the CCG 2961 AML treatment protocol Renal: Specified on the CCG 2961 AML treatment protocol

PRIOR CONCURRENT THERAPY: Specified on the CCG 2961 AML treatment protocols

Treatment and study plan

polymerase chain reaction

Genetic

flow cytometry

Other

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

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start: 1995
Primary completion: 2002
Study completion: 2006
First posted: Apr 23, 2004
Registry last updated: Aug 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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