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

Tracking Information

First Received Date ^ICMJE

November 1, 1999

Last Updated Date

February 6, 2009

Start Date ^ICMJE

February 1995

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00003790 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic

Condition ^ICMJE

Leukemia
Myelodysplastic Syndromes

Intervention ^ICMJE

Genetic: polymerase chain reaction
Other: flow cytometry

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

400

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

up to 21 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, Canada

Administrative Information

NCT ID ^ICMJE

NCT00003790

Responsible Party

Study ID Numbers ^ICMJE

CDR0000066930, CCG-B942

Study Sponsor ^ICMJE

Children's Cancer Group

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Eric Sievers, MD

Fred Hutchinson Cancer Research Center

Information Provided By

National Cancer Institute (NCI)

Verification Date

July 2001

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP