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

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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


Primary Outcome

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


Condition

Acute Lymphoblastic Leukemia

Intervention

Cytology Specimen Collection Procedure

Study Arms / Comparison Groups

 Ancillary-Correlative (classification)
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

17463

Start Date

August 9, 2010


Primary Completion Date

May 1, 2015

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
      

Gender

All

Ages

N/A - 30 Years

Accepts Healthy Volunteers

No

Contacts

Karen R Rabin, , 

Location Countries

Australia

Location Countries

Australia

Administrative Informations


NCT ID

NCT01142427

Organization ID

AALL08B1

Secondary IDs

NCI-2011-02235

Responsible Party

Sponsor

Study Sponsor

Children's Oncology Group

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Karen R Rabin, Principal Investigator, Children's Oncology Group


Verification Date

October 2019