NCT Number: NCT01005368
Study of Biomarkers in Blood and Bone Marrow Samples From Patients With Previously Untreated Chronic Lymphocytic Leukemia
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.
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Notify MeKey information
Conditions
Sex eligibility
All sexes
Study type
Observational
Primary location
Kaiser Permanente Medical Office -Vandever Medical Office, San Diego, California, United States
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
mutation analysis
Geneticnucleic acid sequencing
Geneticpolymerase chain reaction
Geneticwestern blotting
Geneticflow cytometry
Otherlaboratory biomarker analysis
OtherPrimary outcomes
-
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
Sponsors and collaborators
Lead sponsor
Alliance for Clinical Trials in Oncology
Other
Collaborators
- National Cancer Institute (NCI)
Registry information
Official study title
Molecular Markers Of Chronic Lymphocytic Leukemia
Important dates
- Study start
- 2009
- Primary completion
- 2022
- Study completion
- 2022
- First posted
- Oct 30, 2009
- Registry last updated
- Aug 3, 2022
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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