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Molecular Markers Of Chronic Lymphocytic Leukemia


N/A
N/A
N/A
Open (Enrolling)
Both
Leukemia

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Trial Information

Molecular Markers Of 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.

Inclusion Criteria


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

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

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)

Safety Issue:

No

Principal Investigator

John C. Byrd, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Ohio State University Comprehensive Cancer Center

Authority:

Unspecified

Study ID:

CDR0000398201

NCT ID:

NCT01005368

Start Date:

Completion Date:

Related Keywords:

  • Leukemia
  • chronic lymphocytic leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

Name

Location

National Naval Medical CenterBethesda, Maryland  20889
University of Chicago Cancer Research CenterChicago, Illinois  60637
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
Veterans Affairs Medical Center - MinneapolisMinneapolis, Minnesota  55417
Louis A. Weiss Memorial HospitalChicago, Illinois  60640
Fletcher Allen Health Care - University Health Center CampusBurlington, Vermont  05401
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Presbyterian Cancer Center at Presbyterian HospitalCharlotte, North Carolina  28233-3549
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
CCOP - Hematology-Oncology Associates of Central New YorkEast Syracuse, New York  13057
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
UNMC Eppley Cancer Center at the University of Nebraska Medical CenterOmaha, Nebraska  68198-7680
New York Weill Cornell Cancer Center at Cornell UniversityNew York, New York  10021
Lombardi Comprehensive Cancer Center at Georgetown University Medical CenterWashington, District of Columbia  20007
CancerCare of Maine at Eastern Maine Medical CenterBangor, Maine  04401
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
Kaiser Permanente Medical Office -Vandever Medical OfficeSan Diego, California  92120
Fort Wayne Medical Oncology and HematologyFort Wayne, Indiana  46815
Saint Francis Cancer Treatment Center at Saint Francis Memorial Health CenterGrand Island, Nebraska  68803
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Mountainview MedicalBerlin, Vermont  05602
Missouri Baptist Cancer CenterSt. Louis, Missouri  63131
Western Pennsylvania Cancer Institute at Western Pennsylvania HospitalPittsburgh, Pennsylvania  15224-1791
Tunnell Cancer Center at Beebe Medical CenterLewes, Delaware  19958
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer CenterColumbus, Ohio  43210-1240
Pardee Memorial HospitalHendersonville, North Carolina  28791
Harold Alfond Center for Cancer CareAugusta, Maine  04330
Union Hospital of Cecil CountyElkton MD, Maryland  21921
Kinston Medical SpecialistsKinston, North Carolina  28501
McLeod Regional Medical CenterFlorence, South Carolina  29501
Callahan Cancer Center at Great Plains Regional Medical CenterNorth Platte, Nebraska  69103
Southeast Cancer CenterCape Girardeau, Missouri  63703
Goldschmidt Cancer CenterJefferson City, Missouri  65109