Overview

This trial is active, not recruiting.

Condition leukemia
Treatments fluorescence in situ hybridization, mutation analysis, nucleic acid sequencing, polymerase chain reaction, western blotting, flow cytometry, laboratory biomarker analysis
Sponsor Alliance for Clinical Trials in Oncology
Collaborator National Cancer Institute (NCI)
Start date October 2009
End date January 2100
Trial size 600 participants
Trial identifier NCT01005368, CALGB-20203, CDR0000398201

Summary

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

PURPOSE: This research study is looking at biomarkers in blood and bone marrow samples from patients with previously untreated chronic lymphocytic leukemia.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective retrospective
Arm
Blood and bone marrow is collected at baseline, 3 months after completion of induction therapy, 2 months after completion of consolidation therapy, 1 year after completion of study treatment, and at disease relapse. Samples are analyzed by FISH for interphase cytogenetics, PCR for IgV_H mutational status, flow cytometry for surface expression of CD38 cells, western blot to assess Mcl-1, Bcl-2, BAK-1, ATM, ZAP-70, and Bar expression, and sequencing for p53 and ATM function.
fluorescence in situ hybridization
mutation analysis
nucleic acid sequencing
polymerase chain reaction
western blotting
flow cytometry
laboratory biomarker analysis

Primary Outcomes

Measure
complete response
time frame: Up to 10 years
prolonged progression-free survival
time frame: Up to 10 years
overall survival
time frame: Up to 10 years

Eligibility Criteria

Male or female participants of any age.

DISEASE CHARACTERISTICS: - Diagnosis of chronic lymphocytic leukemia - Previously untreated disease - Registered to receive treatment on a Cancer and Leukemia Group B protocol PATIENT CHARACTERISTICS: - Not specified PRIOR CONCURRENT THERAPY: - See Disease Characteristics

Additional Information

Official title Molecular Markers Of Chronic Lymphocytic Leukemia
Description OBJECTIVES: - Determine the relevance of common and uncommon interphase cytogenetic abnormalities related to baseline clinical features, complete response (CR), prolonged progression-free survival (PFS), and overall survival (OS) in patients with previously untreated chronic lymphocytic leukemia. - Determine the significance of the absence of IgV_H gene mutational status as related to the ability to predict CR, PFS, and OS in these patients. - Correlate IgV_H gene mutational status with CD38 expression, ZAP-70 expression, over-expression of Mcl-1, BAK-1, high Mcl-1:Bax ratio, p53 mutations or dysfunction, high-risk karyotype abnormalities, and other molecular features associated with poor outcome in these patients. - Determine the prognostic significance of over-expression of Mcl-1, BAK-1, high Mcl-1:Bax ratio, p53 mutations or dysfunction, ATM mutation, ATM expression, and other factors that disrupt apoptosis with respect to CR, prolonged PFS, and OS. - Determine if clonal evolution occurs in these biological markers at partial response or disease relapse. OUTLINE: This is a multicenter study. Blood and bone marrow is collected at baseline, 3 months after completion of induction therapy, 2 months after completion of consolidation therapy, 1 year after completion of study treatment, and at disease relapse. Samples are analyzed by FISH for interphase cytogenetics, PCR for IgV_H mutational status, flow cytometry for surface expression of CD38 cells, western blot to assess Mcl-1, Bcl-2, BAK-1, ATM, ZAP-70, and Bar expression, and sequencing for p53 and ATM function.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Alliance for Clinical Trials in Oncology.