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

Sponsor

Children's Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00003790

Collaborator

National Cancer Institute (NCI) (NIH)

496

Enrollment

Locations

139

Duration (Months)

11.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia Myelodysplastic Syndromes	Genetic: polymerase chain reaction Other: flow cytometry

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 Design

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 :

Feb 1, 1995

Actual Primary Completion Date :

Apr 1, 2002

Actual Study Completion Date :

Sep 1, 2006

Outcome Measures

Primary Outcome Measures

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. [12 months from achievement of remission]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Long Beach Memorial Medical Center	Long Beach	California	United States	90806
2	Children's Hospital Los Angeles	Los Angeles	California	United States	90027-0700
3	USC/Norris Comprehensive Cancer Center	Los Angeles	California	United States	90033-0800
4	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California	United States	90095-1781
5	Children's Hospital of Orange County	Orange	California	United States	92868
6	UCSF Cancer Center and Cancer Research Institute	San Francisco	California	United States	94115-0128
7	David Grant Medical Center	Travis Air Force Base	California	United States	94535
8	Children's Hospital of Denver	Denver	Colorado	United States	80218
9	Children's National Medical Center	Washington	District of Columbia	United States	20010-2970
10	University of Chicago Cancer Research Center	Chicago	Illinois	United States	60637
11	Indiana University Cancer Center	Indianapolis	Indiana	United States	46202-5265
12	University of Iowa Hospitals and Clinics	Iowa City	Iowa	United States	52242
13	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan	United States	48109-0752
14	CCOP - Kalamazoo	Kalamazoo	Michigan	United States	49007-3731
15	University of Minnesota Cancer Center	Minneapolis	Minnesota	United States	55455
16	Mayo Clinic Cancer Center	Rochester	Minnesota	United States	55905
17	Wayne Hughes Institute	Roseville	Minnesota	United States	55113
18	Children's Mercy Hospital	Kansas City	Missouri	United States	64108
19	University of Nebraska Medical Center	Omaha	Nebraska	United States	68198-3330
20	Saint Peter's University Hospital	New Brunswick	New Jersey	United States	08901-9971
21	Cancer Institute of New Jersey	New Brunswick	New Jersey	United States	08901
22	NYU School of Medicine's Kaplan Comprehensive Cancer Center	New York	New York	United States	10016
23	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10021
24	Herbert Irving Comprehensive Cancer Center	New York	New York	United States	10032
25	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina	United States	27599-7295
26	Veterans Affairs Medical Center - Fargo	Fargo	North Dakota	United States	58102
27	CCOP - Merit Care Hospital	Fargo	North Dakota	United States	58122
28	Children's Hospital Medical Center - Cincinnati	Cincinnati	Ohio	United States	45229-3039
29	Ireland Cancer Center	Cleveland	Ohio	United States	44106-5065
30	Children's Hospital of Columbus	Columbus	Ohio	United States	43205-2696
31	Doernbecher Children's Hospital	Portland	Oregon	United States	97201-3098
32	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104
33	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213
34	Center for Cancer Treatment and Research	Columbia	South Carolina	United States	29203
35	Vanderbilt Cancer Center	Nashville	Tennessee	United States	37232-6838
36	University of Texas - MD Anderson Cancer Center	Houston	Texas	United States	77030-4009
37	Huntsman Cancer Institute	Salt Lake City	Utah	United States	84132
38	Children's Hospital and Regional Medical Center - Seattle	Seattle	Washington	United States	98105
39	Fred Hutchinson Cancer Research Center	Seattle	Washington	United States	98109
40	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin	United States	53792
41	Princess Margaret Hospital for Children	Perth	Western Australia	Australia	6001
42	British Columbia Children's Hospital	Vancouver	British Columbia	Canada	V6H 3V4
43	IWK Grace Health Centre	Halifax	Nova Scotia	Canada	B3J 3G9