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

This study has suspended participant recruitment.
(Trial suspension due to NCI NCTN transition.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT01005368
First received: October 29, 2009
Last updated: July 9, 2015
Last verified: July 2015

October 29, 2009
July 9, 2015
October 2009
January 2100   (final data collection date for primary outcome measure)
  • complete response [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • prolonged progression-free survival [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • Significance of absence of IgVH gene mutational status as related to the ability to predict CR, PFS, and OS [ Designated as safety issue: No ]
  • 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) [ Designated as safety issue: No ]
  • Clonal evolution [ Designated as safety issue: No ]
  • Correlation of IgVH gene mutational status with CD38 and ZAP-70 expression, over-expression of Mcl-1, BAK-1, high Mcl-1:Bax ratio, p53 mutation or dysfunction, high-risk karyotype abnormalities, other molecular features associated with poor outcome [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01005368 on ClinicalTrials.gov Archive Site
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Study of Biomarkers in Blood and Bone Marrow Samples From Patients With Previously Untreated Chronic Lymphocytic Leukemia
Molecular Markers Of 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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
Description:

blood and bone marrow samples

Non-Probability Sample

Patients diagnosed with chronic lymphocytic leukemia and were previously untreated. The patients must have also previously enrolled on a Cancer and Leukemia Group B protocol.

Leukemia
  • 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
Group 1
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.
Interventions:
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
600
Not Provided
January 2100   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01005368
CALGB-20203, CALGB-20203, CDR0000398201
No
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: John C. Byrd, MD Ohio State University Comprehensive Cancer Center
Alliance for Clinical Trials in Oncology
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP