Completed

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

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What is being collected

Genetic Data

+ other Data

GeneticOther
Who is being recruted

Bone Marrow Diseases+4

+ Hematologic Diseases

+ Hemic and Lymphatic Diseases

Until 21 Years
See all eligibility criteria
How is the trial designed

Observational
Study Start: February 1995
See protocol details

Summary

Principal SponsorChildren's Oncology Group
Last updated: August 6, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 1995

Actual date on which the first participant was enrolled.

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.

NCT00003790
Principal SponsorChildren's Oncology Group
Last updated: August 6, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

496 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Until 21 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesNeoplasmsNeoplasms by Histologic TypeLeukemiaMyelodysplastic Syndromes

Criteria

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 43 locations

Long Beach Memorial Medical Center

Long Beach, United StatesOpen Long Beach Memorial Medical Center in Google Maps

Children's Hospital Los Angeles

Los Angeles, United States

USC/Norris Comprehensive Cancer Center

Los Angeles, United States

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, United States
Completed43 Study Centers