NCT01005368

Study of Biomarkers in Blood and Bone Marrow Samples From Patients With Previously Untreated Chronic Lymphocytic Leukemia

Molecular Markers Of Chronic Lymphocytic Leukemia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Leukemia

Interventions

Type	Name	Description
GENETIC	fluorescence in situ hybridization
GENETIC	mutation analysis
GENETIC	nucleic acid sequencing
GENETIC	polymerase chain reaction
GENETIC	western blotting
OTHER	flow cytometry
OTHER	laboratory biomarker analysis

Timeline

• Start date: 2009-10-01
• Primary completion: 2022-04-01
• Completion: 2022-04-01
• First posted: 2009-10-30
• Last updated: 2022-08-03

Locations

35 sites across 1 country: United States