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


B-cell Adult Acute Lymphoblastic Leukemia | B-cell Childhood Acute Lymphoblastic Leukemia | T-cell Adult Acute Lymphoblastic Leukemia | T-cell Childhood Acute Lymphoblastic Leukemia | Untreated Adult Acute Lymphoblastic Leukemia | Untreated Childhood Acute Lymphoblastic Leukemia

Trial Phase


Trial Purpose and Description

Trial 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.

Trial Description



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.


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.

Participation Guidelines

Up to 30 Years

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 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

- 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

- All patients and/or their parents or legal guardians must sign a written informed

- 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
Children's Oncology Group
National Cancer Institute (NCI)
August 2010
Last Updated:
September 9, 2014
Study HIC#:

Clinicaltrials.gov ID: NCT01142427