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Trial record 2 of 2 for:    aall08b1
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Risk-Based Classification System of Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01142427
Recruitment Status : Active, not recruiting
First Posted : June 11, 2010
Last Update Posted : March 24, 2023
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Study Description
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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.

Condition or disease Intervention/treatment
Acute Lymphoblastic Leukemia Other: Cytology Specimen Collection Procedure Other: Laboratory Biomarker Analysis

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 Design
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Study Type : Observational
Actual Enrollment : 17463 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Classification of Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)
Actual Study Start Date : August 9, 2010
Actual Primary Completion Date : May 1, 2015

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 Other: Cytology Specimen Collection Procedure
Correlative studies
Other Name: Cytologic Sampling

Other: Laboratory Biomarker Analysis
Correlative studies


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. Classification data for correlative studies [ Time Frame: Up to 5 years ]
  3. Development of a central reference guide for required and research ALL studies [ Time Frame: Up to 5 years ]
  4. Development of mechanism for optional leukemia and germline specimens for current and future research [ Time Frame: Up to 5 years ]

Biospecimen Retention:   Samples With DNA
Blood and bone marrow

Eligibility Criteria
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Ages Eligible for Study:   up to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with newly diagnosed ALL treated at COG
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01142427


Locations
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Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Karen R Rabin Children's Oncology Group
More Information
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Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01142427    
Other Study ID Numbers: AALL08B1
NCI-2011-02235 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000674844
AALL08B1
COG-AALL08B1
PAALL08B1_A09PAMDREVW01
AALL08B1 ( Other Identifier: Childrens Oncology Group )
AALL08B1 ( Other Identifier: CTEP )
U10CA180886 ( U.S. NIH Grant/Contract )
U10CA098543 ( U.S. NIH Grant/Contract )
First Posted: June 11, 2010    Key Record Dates
Last Update Posted: March 24, 2023
Last Verified: March 2023
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases