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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Children's Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01142427
First received: June 10, 2010
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

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 Intervention
Untreated Adult Acute Lymphoblastic Leukemia
Untreated Childhood Acute Lymphoblastic Leukemia
Other: laboratory biomarker analysis
Other: cytology specimen collection procedure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Classification of Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)

Resource links provided by NLM:


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 with newly diagnosed 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

Bone Marrow Sample Blood Sample


Estimated Enrollment: 11750
Study Start Date: August 2010
Estimated Primary Completion Date: January 2100 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Health research services (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: laboratory biomarker analysis
Correlative studies
Other: cytology specimen collection procedure
Correlative studies
Other Name: cytologic sampling

Detailed Description:

PRIMARY OBJECTIVES:

I. 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.

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.

  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

Newly diagnosed acute leukemia

Criteria

Inclusion Criteria:

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

    • > 25% blasts by bone marrow (BM) aspirate
    • If a BM aspirate is not obtained or is not diagnostic of acute leukemia, the diagnosis of acute leukemia can be established by a pathologic diagnosis of acute leukemia on a BM biopsy
    • A complete blood count (CBC) documenting the presence of at least 1,000/µL 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
  • 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
  • Samples must be sent to a COG-approved cytogenetics laboratory, and COG Reference Laboratory studies
  • 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
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: NCT01142427

  Show 230 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Karen Rabin, MD Children's Oncology Group
  More Information

No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01142427     History of Changes
Other Study ID Numbers: AALL08B1, NCI-2011-02235, CDR0000674844, COG-AALL08B1, AALL08B1, AALL08B1, U10CA180886, U10CA098543
Study First Received: June 10, 2010
Last Updated: August 14, 2014
Health Authority: United States: Institutional Review Board

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 August 20, 2014