Genetic Risk Classes in Adult Acute Lymphocytic Leukemia
15 Years
65 Years
Both
Leukemia
Trial Information
Genetic Risk Classes in Adult Acute Lymphocytic Leukemia
OBJECTIVES:
- Identify genes involved in specific biologic processes or molecular functions that
contribute to the mechanisms by which the BCR/ABL tyrosine kinase induces a leukemic
phenotype using RNA banked from patients with BCR/ABL-positive acute lymphoblastic
leukemia (ALL) enrolled on ECOG-2993.
- Compare patterns of mRNA expression of BCR/ABL fusion protein in patients with
B-lineage ALL vs patients with ALL and no cytogenetic abnormalities enrolled on
ECOG-2993.
- Determine both shared and differing expression patterns in patients with
BCR/ABL-positive and cytogenetically negative ALL with respect to achievement of
complete remission and duration of disease-free and overall survival.
OUTLINE: This is a multicenter study.
Total RNA is isolated from stored tissue samples and integrity is verified by reverse
transcription-polymerase chain reaction (RT-PCR). cDNA libraries are created from total RNA
and gene expression is analyzed via microarray analysis.
Genes of interest are further analyzed by flow cytometry and RT-PCR.
PROJECTED ACCRUAL: A total of 137 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Confirmed diagnosis of acute lymphoblastic leukemia
- Tissue banked on protocol ECOG-2993 meeting the following criteria:
- Leukemic blast cell population immunophenotyped in detail (e.g., including CD25)
in ECOG's Immunophenotyping Reference Laboratory
- Flow cytometric analysis of gated blast cells reveals association with the
B-cell lineage
- Mononuclear cell fraction used for RNA isolation contains 75-99% blasts (median
85%)
- Negative for TEL/AML1, MLL/AF4, and E2A/PBX1 by qualitative reverse
transcription-polymerase chain reaction (RT-PCR)
- No FLT3 gene mutations
- BCR/ABL-positive samples meeting the following criteria:
- Presence of t(9;22)(q34;q11) by standard cytogenetics
- Detection of either p190 BCR/ABL or p210 BCR/ABL transcripts by qualitative
RT-PCR
- Patients with genetic risk factors must meet the following criterion:
- Only a normal diploid karyotype is present in ≥ 15 metaphases by standard
cytogenetics
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
Type of Study:
Observational
Study Design:
N/A
Outcome Measure:
Genes involved in specific biologic processes or molecular functions that contribute to the mechanisms by which the BCR/ABL tyrosine kinase induces a leukemic phenotype
Safety Issue:
No
Principal Investigator
Elisabeth Paietta, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Our Lady of Mercy Medical Center Comprehensive Cancer Center
Authority:
Unspecified
Study ID:
CDR0000526268
NCT ID:
NCT00898261
Start Date:
Completion Date:
Related Keywords:
- Leukemia
- adult acute lymphoblastic leukemia in remission
- Leukemia
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
Name | Location |
|---|
