Gene Expression in Tissue From Patients With Acute Lymphoblastic Leukemia

Leukemia Clinical Trial

Official title:

Genetic Risk Classes in Adult Acute Lymphocytic Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00898261
• Other study ID #: CDR0000526268
• Secondary ID: ECOG-E2993T1
• Status: Completed
• Phase: N/A
• First received: May 9, 2009
• Last updated: May 17, 2017
• Start date: October 26, 2007
• Est. completion date: July 19, 2012

Study information

• Verified date: May 2017
• Source: Eastern Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

RATIONALE: Studying the genes expressed in samples of tumor tissue from patients with cancer may help doctors identify biomarkers related to cancer.

PURPOSE: This laboratory study is looking at gene expression in tissue from patients with acute lymphoblastic leukemia enrolled in clinical trial ECOG-2993.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: July 19, 2012
• Est. primary completion date: July 19, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Genetic:
• microarray analysis

• reverse transcriptase-polymerase chain reaction

Other:
• flow cytometry

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
ECOG-ACRIN Cancer Research Group	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		1 month
Primary	Comparison of patterns of mRNA expression of BCR/ABL fusion protein in patients with B-lineage acute lymphoblastic leukemia (ALL) vs patients with ALL who lack cytogenetic abnormalities		1 month
Primary	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		1 month