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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00003790
First received: November 1, 1999
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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 Intervention
Leukemia
Myelodysplastic Syndromes
Genetic: polymerase chain reaction
Other: flow cytometry

Study Type: Observational
Official Title: Detection of Minimal Residual Disease in Children Receiving Therapy for AML or MDS

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

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. [ Time Frame: 12 months from achievement of remission ] [ Designated as safety issue: No ]

Enrollment: 496
Study Start Date: February 1995
Study Completion Date: September 2006
Primary Completion Date: April 2002 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with acute myeloid leukemia or myelodysplastic syndrome (MDS) enrolled on the CCG 2961 AML treatment protocol.

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003790

  Show 43 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Eric Sievers, MD Fred Hutchinson Cancer Research Center
  More Information

Additional Information:
No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00003790     History of Changes
Other Study ID Numbers: B942, CCG-B942, CDR0000066930
Study First Received: November 1, 1999
Last Updated: August 5, 2014
Health Authority: United States: Federal Government

Keywords provided by Children's Oncology Group:
recurrent childhood acute myeloid leukemia
untreated childhood acute myeloid leukemia and other myeloid malignancies
de novo myelodysplastic syndromes
previously treated myelodysplastic syndromes
secondary myelodysplastic syndromes

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Myelodysplastic Syndromes
Preleukemia
Neoplasm, Residual
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on August 21, 2014