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Risk-Based Classification System of Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01142427
First received: June 10, 2010
Last updated: June 3, 2013
Last verified: June 2013
History of Changes
  Purpose

RATIONALE: Gathering health information about patients with acute lymphoblastic leukemia may help doctors learn more about the disease and plan the best treatment.

PURPOSE: This research study is developing a risk-based classification system for patients with newly diagnosed acute lymphoblastic leukemia.


Condition Intervention
Leukemia
 Genetic: DNA ploidy analysis
Genetic: chromosomal translocation analysis
Genetic: cytogenetic analysis
Genetic: fluorescence in situ hybridization
Other: cytology specimen collection procedure
Other: flow cytometry
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: Classification of Newly Diagnosed Acute Lymphoblastic Leukemia

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Development of a risk-based classification system to be used to assign patients newly diagnosed with acute lymphoblastic leukemia (ALL) to frontline specific-treatment studies [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Development of a classification data for correlative studies [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Development of a central reference guide for required and research ALL studies [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Development of leukemia and germline specimens for current and future research [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Some samples (leukemic and germline) may be banked for current and/or future analyses.


Estimated Enrollment: 11500
Study Start Date: August 2010
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Health research services (classification)
Patients undergo blood sample collection, cytology specimen collection procedure, and bone marrow biopsies at baseline and during and after induction therapy for immunophenotyping for ALL confirmation and classification, DNA ploidy analysis, genomic variation, and cytogenetic analysis (BCR-ABL, trisomies 4+10, and molecular testing for chromosomal translocation analysis) by flow cytometry and FISH (fluorescence in situ hybridization) and laboratory biomarker analysis. Immunophenotype results obtained on this study are used to determine patient's assignment to specific clinical-trial treatments.
 Genetic: DNA ploidy analysis
Correlative studies
Genetic: chromosomal translocation analysis
Correlative studies
Genetic: cytogenetic analysis
Correlative studies
Genetic: fluorescence in situ hybridization
Correlative studies
Other: cytology specimen collection procedure
Correlative studies
Other: flow cytometry
Immunophenotypic characterization of the leukemic cells
Other Name: Immunophenotype (Flow Cytometry) at diagnosis
Other: laboratory biomarker analysis
Correlative Studies

Detailed Description:

OBJECTIVES:

  • To provide a risk-based classification system based on clinical, pathological, molecular, and early response data that will be used to assign all patients with newly diagnosed acute lymphoblastic leukemia (ALL) to the Children's Oncology Group (COG) frontline specific-treatment studies.
  • To capture classification data for correlative studies accompanying current COG ALL treatment protocols.
  • To provide a central reference guide for all required and research studies that will be conducted in local and reference laboratories for all newly diagnosed ALL patients.
  • To provide a mechanism for optional banking of leukemia and germline specimens for current and future research.

OUTLINE: This is a multicenter study. Patients are stratified according to diagnosis (B-cell precursor vs infant vs T-cell acute lymphoblastic leukemia [ALL]).

Patients undergo blood sample collection and bone marrow biopsies at baseline and during and after induction therapy for immunophenotyping for ALL confirmation and classification, DNA ploidy, genomic variation, and cytogenetic (BCR-ABL, trisomies 4+10, and molecular testing for translocations) analysis by flow cytometry and FISH. Immunophenotype results obtained on this study are used to determine patient's assignment to specific clinical-trial treatments.

Some samples (leukemic and germline) may be banked for current and/or future analyses.

  Eligibility

Ages Eligible for Study:   up to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with newly diagnosed ALL who are treated by COG

Criteria

DISEASE CHARACTERISTICS:

  • Newly diagnosed acute leukemia meeting 1 of the following criteria:

    • ≥ 25% blasts by bone marrow aspirate
    • Acute leukemia diagnosed by bone marrow biopsy
    • Complete blood count with documented leukemia blasts of ≥ 1,000/μL

  • Patients with suspected acute lymphoblastic leukemia (ALL) who have true biphenotypic or bilineage leukemia (i.e., patient with significant blasts expression of multiple lymphoid and myeloid markers that cannot be assignment to a single lineage) are allowed to enroll in AALL08B1 cell banking

    • No patients with blast-myeloid morphology or whose blasts are myeloperoxidase positive
  • Patients with high-risk or very high-risk disease may enroll in AALL1131
  • No secondary ALL

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • No prior cytotoxic therapy

    • Prior steroids or intrathecal chemotherapy allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01142427

  Show 201 Study Locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Karen Rabin, MD Texas Children's Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01142427     History of Changes
Other Study ID Numbers: AALL08B1, COG-AALL08B1, CDR0000674844
Study First Received: June 10, 2010
Last Updated: June 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Oncology Group:
untreated adult acute lymphoblastic leukemia
untreated childhood acute lymphoblastic leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on June 17, 2013