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

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ClinicalTrials.gov Identifier: NCT01142427
Recruitment Status : Recruiting
First Posted : June 11, 2010
Last Update Posted : February 14, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

June 10, 2010
June 11, 2010
February 14, 2017
August 2010
January 2100   (Final data collection date for primary outcome measure)
  • Classification data for correlative studies [ Time Frame: Up to 5 years ]
  • Development of a central reference guide for required and research ALL studies [ Time Frame: Up to 5 years ]
  • Development of a risk classification system to be used to assign patients to treatment on COG frontline ALL treatment studies [ Time Frame: Up to 5 years ]
  • Development of mechanism for optional leukemia and germline specimens for current and future research [ Time Frame: Up to 5 years ]
  • 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
  • Development of a classification data for correlative studies
  • Development of a central reference guide for required and research ALL studies
  • Development of leukemia and germline specimens for current and future research
Complete list of historical versions of study NCT01142427 on ClinicalTrials.gov Archive Site
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Risk-Based Classification System of Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Classification of Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)
This research trial studies a risk-based classification system for patients with newly diagnosed acute lymphoblastic leukemia. Gathering health information about patients with acute lymphoblastic leukemia may help doctors learn more about the disease and plan the best treatment.

PRIMARY OBJECTIVES:

I. To provide a risk classification scheme for all patients with newly diagnosed acute lymphoblastic leukemia (ALL), which will be used to assign treatment on Children's Oncology Group (COG) frontline ALL treatment studies.

II. To capture classification data for correlative studies accompanying current COG ALL treatment protocols.

III. 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.

IV. To provide a mechanism for optional banking of leukemia and germline specimens for current and future research.

OUTLINE:

Patients undergo blood sample collection and bone marrow biopsies at baseline and during and after induction therapy for immunophenotyping for ALL confirmation and classification, deoxyribonucleic acid (DNA) ploidy, genomic variation, and cytogenetic (BCR-ABL, trisomies 4+10, and molecular testing for translocations) analysis by flow cytometry and fluorescent in situ hybridization (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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Blood and bone marrow
Non-Probability Sample
Patients with newly diagnosed ALL treated at COG
  • Adult B Acute Lymphoblastic Leukemia
  • Adult T Acute Lymphoblastic Leukemia
  • Childhood B Acute Lymphoblastic Leukemia
  • Childhood T Acute Lymphoblastic Leukemia
  • Untreated Adult Acute Lymphoblastic Leukemia
  • Untreated Childhood Acute Lymphoblastic Leukemia
  • Other: Cytology Specimen Collection Procedure
    Correlative studies
    Other Name: Cytologic Sampling
  • Other: Laboratory Biomarker Analysis
    Correlative studies
Ancillary-Correlative (classification)
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.
Interventions:
  • Other: Cytology Specimen Collection Procedure
  • Other: Laboratory Biomarker Analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
14250
Not Provided
January 2100   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient has newly diagnosed acute leukemia:

    • > 25% blasts on a bone marrow (BM) aspirate or
    • If a BM aspirate is not obtained or is not diagnostic of acute leukemia, the diagnosis can be established by a pathologic diagnosis of acute leukemia on a BM biopsy or
    • A complete blood count (CBC) documenting the presence of at least 1,000/uL circulating leukemic blasts
  • Adequate samples must be provided to the reference and/or COG-approved cytogenetics laboratories to allow completion of the studies needed for risk-stratification

    • If a BM aspirate is not performed, or adequate material cannot be obtained, peripheral blood (PB) can be substituted for BM if there are at least 1,000 circulating blasts/uL (i.e., a white blood cell [WBC] count of 10,000/uL with 10% blasts or a WBC count of 5,000/uL with 20% blasts); if only PB is submitted, please obtain and send twice the volume of PB as the recommended BM volume specified; the patient will remain on AALL08B1 as long as all required central laboratory tests can be successfully performed; as long as there are at least 1,000/uL PB blasts, institutions are encouraged to submit PB in addition to BM samples to make sure that adequate material is available to perform the required studies
    • If an adequate BM aspirate cannot be obtained and there are fewer than 1,000/uL PB blasts, the patient is not eligible for AALL08B1 or a frontline COG ALL clinical trial (there are NO exceptions to this rule)
  • Patient has suspected ALL:

    • Patients whose blast morphology is obviously myeloid, or whose blasts are myeloperoxidase positive, should not be enrolled on AALL08B1; however, patients with true biphenotypic or bilineage leukemia (i.e., patient presents with blasts with significant expression of multiple lymphoid and myeloid markers such that assignment to a single lineage is not possible) are eligible to enroll in AALL08B1 for cell banking
  • Samples must be sent to a COG-approved cytogenetics laboratory, and COG Reference Laboratory studies; if informative results needed for treatment stratification are not available at specified time-points during induction, patients will not be eligible to receive post-induction therapy on a COG ALL trial
  • All patients and/or their parents or legal guardians must sign a written informed consent
  • All institutional, Food and Drug Administration (FDA) and National Cancer Institute (NCI) requirements for human studies must be met

Exclusion Criteria:

  • Patient must not have received prior cytotoxic therapy except for steroids or intrathecal chemotherapy
  • Patient must not have secondary ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy
Sexes Eligible for Study: All
up to 30 Years   (Child, Adult)
No
Australia,   Canada,   Ireland,   New Zealand,   Puerto Rico,   Switzerland,   United States
 
 
NCT01142427
AALL08B1
NCI-2011-02235 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
PAALL08B1_A09PAMDREVW01
CDR0000674844
COG-AALL08B1
AALL08B1 ( Other Identifier: Childrens Oncology Group )
AALL08B1 ( Other Identifier: CTEP )
U10CA180886 ( U.S. NIH Grant/Contract )
U10CA098543 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
Children's Oncology Group
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Karen Rabin Children's Oncology Group
Children's Oncology Group
February 2017