Protocol Summary

Protocol No.: OCR11125

Sponsor Protocol No.: AALL08B1

Study Title
Classification of Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)

Principal Investigator(s)
Slayton, William

Objective
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.

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

Phase: NA

Age Group: Children

Scope: National

Treatment
This is an observational study.

Detailed Eligibility
Inclusion Criteria:
1. Ages up to 30 years old
2. Newly diagnosed acute leukemia meeting 1 of the following criteria:
- 25% blasts by bone marrow (BM) aspirate
- If a BM aspirate is not obtained, 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
3. Adequate samples must be provided to the reference and/or Children's Oncology Group (COG)-approved cytogenetics laboratories to allow completion of the studies needed for risk-stratification
4. 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
5. No patients with blast-myeloid morphology or whose blasts are myeloperoxidase positive
6. Samples must be sent to a COG-approved cytogenetics laboratory, and COG Reference Laboratory studies
7. All patients and/or their parents or legal guardians must sign a written informed consent
8. All institutional, Food and Drug Administration (FDA) and National Cancer Institute (NCI) requirements for human studies must be met

Exclusion Criteria:
1. Patient must not have received prior cytotoxic therapy except for steroids or intrathecal chemotherapy
2. Patient must not have secondary ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy

Applicable Disease Sites
Leukemia
Pediatric (Childhood) Cancer

Participating Institutions
UF Gainesville : Heather Rogers

Contact
Heather Rogers, RN
Phone: +1 352-294-8743

Email: heatherrogers@ufl.edu

More Information:
View study listing on ClinicialTrials.gov
http://www.clinicaltrials.gov/ct2/show/
NCT01142427