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Trial record 2 of 2 for:    aall08b1

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

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ClinicalTrials.gov Identifier: NCT01142427
Recruitment Status : Active, not recruiting
First Posted : June 11, 2010
Last Update Posted : July 25, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Tracking Information
First Submitted Date June 10, 2010
First Posted Date June 11, 2010
Last Update Posted Date July 25, 2018
Actual Study Start Date August 9, 2010
Actual Primary Completion Date May 1, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 24, 2018)
  • Development of a risk classification system to be used to assign patients to treatment on Children?s Oncology Group frontline acute lymphoblastic leukemia (ALL) treatment studies [ Time Frame: Up to 5 years ]
  • 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 mechanism for optional leukemia and germline specimens for current and future research [ Time Frame: Up to 5 years ]
Original Primary Outcome Measures
 (submitted: June 10, 2010)
  • 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
Change History Complete list of historical versions of study NCT01142427 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Risk-Based Classification System of Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Official Title Classification of Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)
Brief Summary 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.
Detailed Description

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.

Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Not Provided
Condition
  • Acute Lymphoblastic Leukemia
  • Blast Cells Present
  • Blasts More Than 25 Percent of Bone Marrow Nucleated Cells
Intervention
  • Other: Cytology Specimen Collection Procedure
    Correlative studies
    Other Name: Cytologic Sampling
  • Other: Laboratory Biomarker Analysis
    Correlative studies
Study Groups/Cohorts 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: July 24, 2018)
17451
Original Estimated Enrollment
 (submitted: June 10, 2010)
9835
Study Completion Date Not Provided
Actual Primary Completion Date May 1, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 30 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Australia,   Canada,   Ireland,   New Zealand,   Puerto Rico,   Switzerland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01142427
Other Study ID Numbers AALL08B1
NCI-2011-02235 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
AALL08B1
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 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Children's Oncology Group
Study Sponsor Children's Oncology Group
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Karen Rabin Children's Oncology Group
PRS Account Children's Oncology Group
Verification Date July 2018