Study of Biomarkers in Blood and Bone Marrow Samples From Patients With Previously Untreated Chronic Lymphocytic Leukemia
Status: | Active, not recruiting |
---|---|
Conditions: | Blood Cancer, Leukemia |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | Any |
Updated: | 1/26/2019 |
Start Date: | October 2009 |
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.
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.
- 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.
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
We found this trial at
35
sites
Harold Alfond Center for Cancer Care MaineGeneral's Harold Alfond Center for Cancer Care (HACCC) is...
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417 State St #30
Bangor, Maine 04401
Bangor, Maine 04401
(207) 973-7478

CancerCare of Maine at Eastern Maine Medical Center Our compassionate, experienced physicians specialize in the...
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200 Hawthorne Lane
Charlotte, North Carolina 28233
Charlotte, North Carolina 28233
704-384-4000

Presbyterian Cancer Center at Presbyterian Hospital At Novant Health Presbyterian Medical Center, we are welcoming...
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115 Business loop 70 w
Columbia, Missouri 65203
Columbia, Missouri 65203
(573) 882-2100

Ellis Fischel Cancer Center at University of Missouri - Columbia At Ellis Fischel Cancer Center,...
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11143 Parkview Plaza Dr # 100
Fort Wayne, Indiana 46845
Fort Wayne, Indiana 46845
(260) 484-8830
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200 Hawkins Drive
Iowa City, Iowa 52242
Iowa City, Iowa 52242
800-237-1225

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Kinston Medical Specialists offers comprehensive medical services for all ages. Whether it’s a case of...
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902 Savannah Road
Lewes, Delaware 19958
Lewes, Delaware 19958
(302) 645-3770
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Tunnell Cancer Center at Beebe Medical Center The Robert & Eolyne Tunnell Cancer Center at...
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1300 York Avenue # A421
New York, New York 10065
New York, New York 10065
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985950 Nebraska Medical Center
Omaha, Nebraska 68198
Omaha, Nebraska 68198
402-559-4090
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UNMC Eppley Cancer Center at the University of Nebraska Medical Center The Fred & Pamela...
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4800 Friendship Avenue
Pittsburgh, Pennsylvania 15224
Pittsburgh, Pennsylvania 15224
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SUNY Upstate Medical University Hospital SUNY Upstate Medical University in Syracuse, NY, is the only...
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42 E Laurel Rd # 2545
Voorhees, New Jersey 08043
Voorhees, New Jersey 08043
(800) 826-6737
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1 Medical Center Blvd
Winston-Salem, North Carolina 27103
Winston-Salem, North Carolina 27103
(336) 716-2011
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Mountainview Medical Our medical oncologists, hematologist, and oncology advanced practice nurse, along with other dedicated...
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Southeast Cancer Center SoutheastHEALTH is a far-reaching network of providers and facilities including Southeast Hospital...
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Columbus, Ohio 43210
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5008 Brittonfield Parkway
East Syracuse, New York 13057
East Syracuse, New York 13057
(315) 472-7504

CCOP - Hematology-Oncology Associates of Central New York Hematology/Oncology Associates of CNY (HOACNY) has participated...
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McLeod Regional Medical Center McLeod Health, a regional presence and predominant healthcare organization, is dedicated...
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Grand Island, Nebraska 68803
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Pardee Memorial Hospital Pardee Hospital is a not-for-profit community hospital founded in 1953 and is...
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4701 Ogletown-Stanton Road
Newark, Delaware 19713
Newark, Delaware 19713
302-623-4450

CCOP - Christiana Care Health Services Christiana Care's Cancer Research Program is part of a...
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Missouri Baptist Cancer Center The Cancer Center at Missouri Baptist is a member of Heartland...
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3970 Reservoir Rd NW E501
Washington, District of Columbia 20007
Washington, District of Columbia 20007
(202) 687-2110

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center Georgetown Lombardi Comprehensive Cancer Center, part...
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