Risk-Based Classification System of Patients With Newly Diagnosed 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-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.


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:

- 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

- 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:
August 14, 2014
Study HIC#:

Clinicaltrials.gov ID: NCT01142427