Fludarabine and Rituximab With or Without Lenalidomide or Cyclophosphamide in Treating Patients With Symptomatic Chronic Lymphocytic Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Southwest Oncology Group
Eastern Cooperative Oncology Group
NCIC Clinical Trials Group
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00602459
First received: January 23, 2008
Last updated: October 21, 2014
Last verified: May 2014
  Purpose

This randomized phase II trial studies how well fludarabine and rituximab with or without lenalidomide or cyclophosphamide works in treating patients with symptomatic chronic lymphocytic leukemia. Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. Giving fludarabine and rituximab together with lenalidomide or cyclophosphamide may kill more cancer cells.


Condition Intervention Phase
B-cell Chronic Lymphocytic Leukemia
Stage I Chronic Lymphocytic Leukemia
Stage II Chronic Lymphocytic Leukemia
Stage III Chronic Lymphocytic Leukemia
Stage IV Chronic Lymphocytic Leukemia
Biological: rituximab
Drug: fludarabine phosphate
Drug: cyclophosphamide
Drug: lenalidomide
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Genetic Risk-Stratified, Randomized Phase II Study of Four Fludarabine/Antibody Combinations for Patients With Symptomatic, Previously Untreated Chronic Lymphocytic Leukemia

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • PFS rate [ Time Frame: Interval between randomization and progression or death, whichever comes first, assessed at 2 years ] [ Designated as safety issue: No ]
    Within each arm, the 2-year PFS will be tested to see whether it is significantly greater than the historical control rate. Rates within each arm will be estimated with their exact 90% confidence intervals. The chi-square test will be used to test whether the 2-year PFS of Arm B is significantly better than that of Arm A.


Secondary Outcome Measures:
  • Induction response rate (complete remission [CR] and partial remission [PR]) [ Time Frame: Up to 15 years ] [ Designated as safety issue: No ]
    Induction response rates within each arm will be estimated with their exact 90% confidence intervals. For Arms A and C, induction response includes any responses occurring after the start of therapy; however, for Arms B and D, induction response includes only those responses occurring before the start of consolidation therapy with lenalidomide.

  • Time-to-progression [ Time Frame: Up to 15 years ] [ Designated as safety issue: No ]
    The log-rank test will be used to test for arm differences in time-to-progression. A Kaplan-Meier analysis will be used to describe the entire distribution of time-to-progression within each arm.

  • PFS rate of patients with del(11q22.3) [ Time Frame: Interval between randomization and progression or death, whichever comes first, assessed at 2 years ] [ Designated as safety issue: No ]
    Two year PFS rate will be estimated with its 90% confidence interval for each arm, and the chi-square test will be used to test whether the 2-year PFS of Arm C is different from that of Arm D.

  • Induction response rates (CR + PR) in patients with del(11q22.3) [ Time Frame: Up to 15 years ] [ Designated as safety issue: No ]
    Induction response rate will be estimated with its 90% confidence interval for each arm.

  • Time-to-progression in patients with del(11q22.3) [ Time Frame: Up to 15 years ] [ Designated as safety issue: No ]
    A Kaplan-Meier analysis will be used to describe the distribution of time-to-progression within each arm and the log-rank test will be used to test for arm differences in time-to-progression.

  • Toxicity as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 16 months ] [ Designated as safety issue: Yes ]
    Each arm will be monitored for toxicities that cause a patient to go permanently off protocol therapy.

  • Interphase cytogenetic abnormalities [ Time Frame: Up to 15 years ] [ Designated as safety issue: No ]
    Will be correlated with induction CR and PR and PFS. CR and PR rates will be estimated within marker-defined subgroups, and the difference in CR and PR rates between subgroups will be estimated with 95% confidence intervals.

  • IgVH gene mutational status [ Time Frame: Up to 15 years ] [ Designated as safety issue: No ]
    Will be correlated with induction CR and PR and PFS. CR and PR rates will be estimated within marker-defined subgroups, and the difference in CR and PR rates between subgroups will be estimated with 95% confidence intervals.

  • CD38 expression [ Time Frame: Up to 15 years ] [ Designated as safety issue: No ]
    Will be correlated with induction CR and PR and PFS. CR and PR rates will be estimated within marker-defined subgroups, and the difference in CR and PR rates between subgroups will be estimated with 95% confidence intervals.

  • CD49d expression [ Time Frame: Up to 15 years ] [ Designated as safety issue: No ]
    Will be correlated with induction CR and PR and PFS. CR and PR rates will be estimated within marker-defined subgroups, and the difference in CR and PR rates between subgroups will be estimated with 95% confidence intervals.

  • ZAP-70 expression [ Time Frame: Up to 15 years ] [ Designated as safety issue: No ]
    Will be correlated with induction CR and PR and PFS. CR and PR rates will be estimated within marker-defined subgroups, and the difference in CR and PR rates between subgroups will be estimated with 95% confidence intervals.

  • P53 dysfunction [ Time Frame: Up to 15 years ] [ Designated as safety issue: No ]
    Will be correlated with induction CR and PR and PFS. CR and PR rates will be estimated within marker-defined subgroups, and the difference in CR and PR rates between subgroups will be estimated with 95% confidence intervals.

  • Change across time from baseline to progression in clonal evolution [ Time Frame: Baseline to up to 15 years ] [ Designated as safety issue: No ]
    Means/medians or proportions will be plotted against time. Analogous patient-specific plots will also be examined.

  • Change across time from baseline to progression in ZAP-70 expression [ Time Frame: Baseline to up to 15 years ] [ Designated as safety issue: No ]
    Means/medians will be plotted against time. Analogous patient-specific plots will also be examined.

  • Change across time from baseline to progression in p53 dysfunction [ Time Frame: Baseline to up to 15 years ] [ Designated as safety issue: No ]
    Proportions will be plotted against time. Analogous patient-specific plots will also be examined.

  • Change across time from baseline to progression in gene expression profile [ Time Frame: Baseline to up to 15 years ] [ Designated as safety issue: No ]
    Means/medians or proportions will be plotted against time. Analogous patient-specific plots will also be examined.

  • Change across time from baseline to progression in epigenetic changes in methylation [ Time Frame: Baseline to up to 15 years ] [ Designated as safety issue: No ]
    Means/medians or proportions will be plotted against time. Analogous patient-specific plots will also be examined.

  • Flow cytometry negativity [ Time Frame: Up to 24 months after study enrollment ] [ Designated as safety issue: No ]
    This objective will examine whether flow cytometry negativity at end of therapy and at 24 months after study enrollment correlates with PFS and OS. PFS and OS will be estimated with the Kaplan-Meier method within subgroups defined by flow cytometry status at 24 months after enrollment; PFS probabilities at given time points will be calculated with 95% confidence intervals. A covariate adjusted hazard ratio will be calculated with the proportional hazards model.


Estimated Enrollment: 405
Study Start Date: January 2008
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm A (rituximab, fludarabine phosphate)
Patients receive rituximab IV over 1-4 hours on days 1, 3, and 5 of course 1 and on day 1 of all subsequent courses. Patients also receive fludarabine phosphate IV over 30 minutes or PO on days 1-5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression.
Biological: rituximab
Given IV
Other Names:
  • IDEC-C2B8
  • IDEC-C2B8 monoclonal antibody
  • Mabthera
  • MOAB IDEC-C2B8
  • Rituxan
Drug: fludarabine phosphate
Given IV or PO
Other Names:
  • 2-F-ara-AMP
  • Beneflur
  • Fludara
Other: laboratory biomarker analysis
Correlative studies
Experimental: Arm B (rituximab, fludarabine phosphate, lenalidomide)
Patients undergo RI therapy as in Arm I. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression. Patients with a complete or partial response or stable disease proceed to RC therapy beginning approximately 4 months after completing the last dose of fludarabine phosphate in course 6, comprising lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Biological: rituximab
Given IV
Other Names:
  • IDEC-C2B8
  • IDEC-C2B8 monoclonal antibody
  • Mabthera
  • MOAB IDEC-C2B8
  • Rituxan
Drug: fludarabine phosphate
Given IV or PO
Other Names:
  • 2-F-ara-AMP
  • Beneflur
  • Fludara
Drug: lenalidomide
Given PO
Other Names:
  • CC-5013
  • IMiD-1
  • Revlimid
Other: laboratory biomarker analysis
Correlative studies
Experimental: Arm C (rituximab, fludarabine phosphate, cyclophosphamide)
Patients receive rituximab IV over 4 hours on days 1 and 3 of course 1 and on day 1 of all subsequent courses. Patients then receive fludarabine phosphate IV piggyback over 30 minutes or PO followed by cyclophosphamide IV piggyback over 30 minutes on days 1-3. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression.
Biological: rituximab
Given IV
Other Names:
  • IDEC-C2B8
  • IDEC-C2B8 monoclonal antibody
  • Mabthera
  • MOAB IDEC-C2B8
  • Rituxan
Drug: fludarabine phosphate
Given IV or PO
Other Names:
  • 2-F-ara-AMP
  • Beneflur
  • Fludara
Drug: cyclophosphamide
Given IV
Other Names:
  • CPM
  • CTX
  • Cytoxan
  • Endoxan
  • Endoxana
Other: laboratory biomarker analysis
Correlative studies
Experimental: Arm D (rituximab, fludarabine, cyclophosphamide, lenalidomide)
Patients receive the first course of RI therapy as in Arm A or B before being re-assigned to Arm D. Beginning in course 2, patients receive rituximab IV on day 1 and fludarabine phosphate IV piggyback over 30 minutes or PO and cyclophosphamide IV piggyback over 30 minutes on days 1-3. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression. Patients with a complete or partial response or stable disease proceed to RC therapy beginning approximately 4 months after completing the last dose of fludarabine phosphate in course 6, comprising lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Biological: rituximab
Given IV
Other Names:
  • IDEC-C2B8
  • IDEC-C2B8 monoclonal antibody
  • Mabthera
  • MOAB IDEC-C2B8
  • Rituxan
Drug: fludarabine phosphate
Given IV or PO
Other Names:
  • 2-F-ara-AMP
  • Beneflur
  • Fludara
Drug: cyclophosphamide
Given IV
Other Names:
  • CPM
  • CTX
  • Cytoxan
  • Endoxan
  • Endoxana
Drug: lenalidomide
Given PO
Other Names:
  • CC-5013
  • IMiD-1
  • Revlimid
Other: laboratory biomarker analysis
Correlative studies

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Specific diagnosis of B-cell CLL:

    • An absolute lymphocytosis of > 5,000/μL

      • Morphologically, the lymphocytes must appear mature with < 55% prolymphocytes
      • Bone marrow examination must include at least a unilateral aspirate and biopsy; the aspirate smear must show > 30% of all nucleated cells to be lymphoid or the bone marrow core biopsy must show lymphoid infiltrates compatible with marrow involvement by CLL; overall cellularity must be normocellular or hypercellular
      • Local institution lymphocyte phenotype must reveal a predominant B-cell monoclonal population sharing a B-cell marker (cluster of differentiation [CD]19, CD20, CD23) with the CD5 antigen, in the absence of other pan-T-cell markers; additionally, the B-cells must be monoclonal with regard to expression of either kappa or lambda and have surface immunoglobulin expression of low density; patients with bright surface immunoglobulin levels must have CD23 co-expression
  • Patients must have symptomatic and active intermediate or high-risk categories of the modified three-stage Rai staging system:

    • Not eligible: low risk, Rai stage 0, lymphocytes (L) in blood (> 5000/uL) and marrow (> 30%) only
    • Intermediate risk, Rai stage I, L + enlarged lymph nodes (LN)
    • Intermediate risk, Rai stage II, L + spleen and/or liver (LN + or -)
    • High risk, Rai stage III, L + anemia (hemoglobin < 11 gm/dL)
    • High risk, Rai stage IV, L + thrombocytopenia (platelets < 100,000/uL)
  • Patients in the intermediate-risk group must have evidence of active disease as demonstrated by at least one of the following criteria:

    • Massive or progressive splenomegaly, hepatomegaly and/or lymphadenopathy
    • Presence of weight loss > 10% over the preceding 6 month period
    • Grade 2 or 3 fatigue
    • Fevers > 100.5°F or night sweats for greater than 2 weeks without evidence of infection
    • Progressive lymphocytosis with an increase of > 50% over a 2 month period or an anticipated doubling time of less than 6 months
  • No prior therapy for CLL, including no corticosteroids for autoimmune complications that have developed since the initial diagnosis of CLL
  • No medical condition requiring chronic use of oral corticosteroids
  • Performance status 0 - 2
  • Patients with human immunodeficiency virus (HIV) infection may be eligible provided they meet the following criteria: no evidence of infection with hepatitis B or C; CD4+ cell count > 350/mm^3; no evidence of resistant strains of HIV; if not on anti-HIV therapy, an HIV viral load < 10,000 copies HIV ribonucleic acid (RNA)/mL; if on HIV therapy, HIV viral load < 50 copies HIV RNA/mL; and no history of acquired immune deficiency syndrome (AIDS)-defining condition; patients receiving concurrent zidovudine or stavudine may not be enrolled
  • Non-pregnant and non-nursing
  • In females of child-bearing potential randomized to Arm B or assigned to Arm D, a negative urine or serum pregnancy test with a sensitivity of at least 25 mIU/mL will be required: 1) 10-14 days prior to beginning lenalidomide consolidation therapy; and 2) within 24 hours prior to the first dose of lenalidomide consolidation therapy; in addition, females of childbearing potential in Arm B and Arm D with regular menses must have a pregnancy test performed weekly during the first 28 days of treatment, and then every 28 days while taking lenalidomide (including breaks in lenalidomide), at discontinuation of lenalidomide, and then 28 days following discontinuation of lenalidomide; if menses are irregular, a pregnancy test must be performed weekly during the first 28 days of treatment, and then every 14 days while taking lenalidomide, at discontinuation of lenalidomide, and at 14 and 28 days after discontinuation of lenalidomide; additionally, females of childbearing potential must either commit to continued abstinence from heterosexual intercourse or begin TWO reliable methods of birth control - one highly effective method (intrauterine device [IUD], hormonal [birth control pills, injections, or implants], tubal ligation, or partner's vasectomy), and one additional effective method (latex condom, diaphragm, or cervical cap) - AT THE SAME TIME, at least 4 weeks before she begins lenalidomide therapy, while participating in the study, and for at least 4 weeks after completing lenalidomide therapy; "females of childbearing potential" is defined as a sexually mature woman who has not undergone a hysterectomy or bilateral oophorectomy, or who has had menses at any time in the preceding 24 consecutive months (not been naturally postmenopausal for at least 24 consecutive months)
  • Male patients randomized to Arm B or reassigned to Arm D must agree not to father a child and to use a latex condom during any sexual contact with females of childbearing potential while taking lenalidomide and for at least 4 weeks following completion of lenalidomide therapy, even if the patient have undergone a successful vasectomy
  • All patients randomized to Arm B or reassigned to Arm D must be counseled by a trained counselor every 28 days during consolidation therapy about pregnancy precautions and risks of fetal exposure
  • Creatinine =< 1.5 x upper limit of normal
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00602459

  Hide Study Locations
Locations
United States, California
Palo Alto Medical Foundation-Camino Division
Mountain View, California, United States, 94040
Palo Alto Medical Foundation Health Care
Palo Alto, California, United States, 94301
Palchak David MD
Pismo Beach, California, United States, 93449
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States, 06105
Norwalk Hospital
Norwalk, Connecticut, United States, 06856
United States, Delaware
Beebe Medical Center
Lewes, Delaware, United States, 19958
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States, 19718
United States, District of Columbia
Lombardi Comprehensive Cancer Center at Georgetown University
Washington, District of Columbia, United States, 20057
United States, Florida
Jupiter Medical Center
Jupiter, Florida, United States, 33458
Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
UF Cancer Center at Orlando Health
Orlando, Florida, United States, 32806
United States, Illinois
Saint Anthony's Health
Alton, Illinois, United States, 62002
MacNeal Hospital and Cancer Center
Berwyn, Illinois, United States, 60402
Illinois CancerCare-Bloomington
Bloomington, Illinois, United States, 61701
Saint Joseph Medical Center
Bloomington, Illinois, United States, 61701
Illinois CancerCare-Canton
Canton, Illinois, United States, 61520
Graham Hospital Association
Canton, Illinois, United States, 61520
Memorial Hospital
Carthage, Illinois, United States, 62321
Illinois CancerCare-Carthage
Carthage, Illinois, United States, 62321
Hematology and Oncology Associates
Chicago, Illinois, United States, 60611
University of Chicago
Chicago, Illinois, United States, 60637
Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
Northwestern University
Chicago, Illinois, United States, 60611
Central Illinois CCOP
Decatur, Illinois, United States, 62526
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Alexian Brothers Medical and Cancer Center
Elk Grove Village, Illinois, United States, 60007
Illinois CancerCare-Eureka
Eureka, Illinois, United States, 61530
Eureka Hospital
Eureka, Illinois, United States, 61530
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, United States, 60201
Illinois CancerCare Galesburg
Galesburg, Illinois, United States, 61401
Galesburg Cottage Hospital
Galesburg, Illinois, United States, 61401
Illinois CancerCare-Havana
Havana, Illinois, United States, 62644
Mason District Hospital
Havana, Illinois, United States, 62644
Hematology Oncology Associates of Illinois-Highland Park
Highland Park, Illinois, United States, 60035
Hopedale Medical Complex - Hospital
Hopedale, Illinois, United States, 61747
Midwest Center for Hematology Oncology
Joliet, Illinois, United States, 60432
Joliet Oncology-Hematology Associates Limited
Joliet, Illinois, United States, 60435
Presence Saint Mary's Hospital
Kankakee, Illinois, United States, 60901
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, United States, 61443
North Shore Hematology Oncology
Libertyville, Illinois, United States, 60048
Illinois CancerCare-Macomb
Macomb, Illinois, United States, 61455
Mcdonough District Hospital
Macomb, Illinois, United States, 61455
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Illinois CancerCare-Monmouth
Monmouth, Illinois, United States, 61462
Holy Family Medical Center
Monmouth, Illinois, United States, 61462
Good Samaritan Regional Health Center
Mount Vernon, Illinois, United States, 62864
DuPage Medical Group-Ogden
Naperville, Illinois, United States, 60563
Illinois Cancer Specialists-Niles
Niles, Illinois, United States, 60714
Community Cancer Center Foundation
Normal, Illinois, United States, 61761
Illinois CancerCare-Community Cancer Center
Normal, Illinois, United States, 61761
Bromenn Regional Medical Center
Normal, Illinois, United States, 61761
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States, 61350
Ottawa Regional Hospital and Healthcare Center
Ottawa, Illinois, United States, 61350
Illinois CancerCare-Pekin
Pekin, Illinois, United States, 61554
Pekin Hospital
Pekin, Illinois, United States, 61554
Pekin Cancer Treatment Center
Pekin, Illinois, United States, 61554
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61603
Illinois CancerCare-Peoria
Peoria, Illinois, United States, 61615
OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61637
Illinois Oncology Research Association CCOP
Peoria, Illinois, United States, 61615
Proctor Hospital
Peoria, Illinois, United States, 61614
Illinois CancerCare-Peru
Peru, Illinois, United States, 61354
Illinois Valley Hospital
Peru, Illinois, United States, 61354
Perry Memorial Hospital
Princeton, Illinois, United States, 61356
Illinois CancerCare-Princeton
Princeton, Illinois, United States, 61356
Swedish American Hospital
Rockford, Illinois, United States, 61104
Hematology Oncology Associates of Illinois - Skokie
Skokie, Illinois, United States, 60076
Illinois CancerCare-Spring Valley
Spring Valley, Illinois, United States, 61362
Saint Margaret's Hospital
Spring Valley, Illinois, United States, 61362
Memorial Medical Center
Springfield, Illinois, United States, 62781-0001
Carle Clinic-Urbana Main
Urbana, Illinois, United States, 61801
Cadence Cancer Center in Warrenville
Warrenville, Illinois, United States, 60555
United States, Indiana
Saint Francis Hospital and Health Centers
Beech Grove, Indiana, United States, 46107
Elkhart Clinic
Elkhart, Indiana, United States, 46514-2098
Michiana Hematology Oncology PC-Elkhart
Elkhart, Indiana, United States, 46514
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Fort Wayne Medical Oncology and Hematology Inc-Parkview
Fort Wayne, Indiana, United States, 46845
Community Howard Regional Health
Kokomo, Indiana, United States, 46904
IU Health La Porte Hospital
La Porte, Indiana, United States, 46350
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, United States, 46545-1470
Michiana Hematology Oncology PC-Mishawaka
Mishawaka, Indiana, United States, 46545-1470
Michiana Hematology Oncology PC-Plymouth
Plymouth, Indiana, United States, 46563
Reid Hospital and Health Care Services
Richmond, Indiana, United States, 47374
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States, 46628
South Bend Clinic
South Bend, Indiana, United States, 46617
Michiana Hematology Oncology PC-South Bend
South Bend, Indiana, United States, 46601
Michiana Hematology Oncology-PC Westville
Westville, Indiana, United States, 46391
United States, Iowa
McFarland Clinic PC-William R Bliss Cancer Center
Ames, Iowa, United States, 50010
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, United States, 50325
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Mercy Capitol
Des Moines, Iowa, United States, 50307
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, United States, 50314
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, United States, 50309
Iowa Oncology Research Association CCOP
Des Moines, Iowa, United States, 50309
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
VA Medical Center - University of Iowa
Iowa City, Iowa, United States, 52246
Ottumwa Regional Health Center
Ottumwa, Iowa, United States, 52501
Mercy Medical Center-Sioux City
Sioux City, Iowa, United States, 51104
Saint Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
Siouxland Hematology Oncology Associates
Sioux City, Iowa, United States, 51101
United States, Kansas
Hays Medical Center
Hays, Kansas, United States, 67601
Promise Regional Medical Center-Hutchinson
Hutchinson, Kansas, United States, 65702
Providence Medical Center
Kansas City, Kansas, United States, 66112
Lawrence Memorial Hospital
Lawrence, Kansas, United States, 66044
Olathe Cancer Center
Olathe, Kansas, United States, 66061
Saint Luke's South Hospital
Overland Park, Kansas, United States, 66213
Menorah Medical Center
Overland Park, Kansas, United States, 66209
Radiation Oncology Practice Corporation Southwest
Overland Park, Kansas, United States, 66210
Via Christi Hospital-Pittsburg
Pittsburg, Kansas, United States, 66762
Kansas City CCOP
Prairie Village, Kansas, United States, 66208
Salina Regional Health Center
Salina, Kansas, United States, 67401
Shawnee Mission Medical Center
Shawnee Mission, Kansas, United States, 66204
Saint Francis Hospital and Medical Center - Topeka
Topeka, Kansas, United States, 66606
Wesley Medical Center
Wichita, Kansas, United States, 67214
United States, Kentucky
Doctors Carrol, Sheth, Raghavan
Louisville, Kentucky, United States, 40215
United States, Maine
Harold Alfond Center for Cancer Care
Augusta, Maine, United States, 04330
Eastern Maine Medical Center
Bangor, Maine, United States, 04401
United States, Maryland
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889-5600
Union Hospital of Cecil County
Elkton MD, Maryland, United States, 21921
Unidentified Site
Rockville, Maryland, United States, 20852
United States, Massachusetts
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States, 01805
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Green Bay Oncology - Escanaba
Escanaba, Michigan, United States, 49431
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States, 49503
Green Bay Oncology - Iron Mountain
Iron Mountain, Michigan, United States, 49801
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
Borgess Medical Center
Kalamazoo, Michigan, United States, 49001
Michiana Hematology Oncology PC-Niles
Niles, Michigan, United States, 49120
Marie Yeager Cancer Center
Saint Joseph, Michigan, United States, 49085
Lakeland Hospital
St. Joseph, Michigan, United States, 49085
Munson Medical Center
Traverse City, Michigan, United States, 49684
United States, Minnesota
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Fairview-Southdale Hospital
Edina, Minnesota, United States, 55435
Unity Hospital
Fridley, Minnesota, United States, 55432
Hutchinson Area Health Care
Hutchinson, Minnesota, United States, 55350
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States, 55109
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, United States, 55109
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States, 55407
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Minneapolis Veterans Medical Center
Minneapolis, Minnesota, United States, 55417
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States, 55422
Metro-Minnesota CCOP
Saint Louis Park, Minnesota, United States, 55416
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States, 55416
Regions Hospital
Saint Paul, Minnesota, United States, 55101
United Hospital
Saint Paul, Minnesota, United States, 55102
Saint Francis Regional Medical Center
Shakopee, Minnesota, United States, 55379
Lakeview Hospital
Stillwater, Minnesota, United States, 55082
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Rice Memorial Hospital
Willmar, Minnesota, United States, 56201
Minnesota Oncology and Hematology PA-Woodbury
Woodbury, Minnesota, United States, 55125
United States, Missouri
Southeast Cancer Center
Cape Girardeau, Missouri, United States, 63703
Saint Francis Medical Center
Cape Girardeau, Missouri, United States, 63703
University of Missouri - Ellis Fischel
Columbia, Missouri, United States, 65212
Centerpoint Medical Center LLC
Independence, Missouri, United States, 64057
Capital Region Medical Center-Goldschmidt Cancer Center
Jefferson City, Missouri, United States, 65109
Heartland Hematology and Oncology Associates Incorporated
Kansas City, Missouri, United States, 64118
Saint Luke's Cancer Institute
Kansas City, Missouri, United States, 64111
Research Medical Center
Kansas City, Missouri, United States, 64132
North Kansas City Hospital
Kansas City, Missouri, United States, 64116
Truman Medical Center
Kansas City, Missouri, United States, 64108
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
Radiation Oncology Practice Corporation - North
Kansas City, Missouri, United States, 64154
Saint Joseph Health Center
Kansas City, Missouri, United States, 64114
Radiation Oncology Practice Corporation South
Kansas City, Missouri, United States, 64114
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, United States, 64086
Liberty Radiation Oncology Center
Liberty, Missouri, United States, 64068
Liberty Hospital
Liberty, Missouri, United States, 64068
Saint Joseph Oncology Inc
Saint Joseph, Missouri, United States, 64507
Heartland Regional Medical Center
Saint Joseph, Missouri, United States, 64506
Saint Louis-Cape Girardeau CCOP
Saint Louis, Missouri, United States, 63141
Center for Cancer Care and Research
Saint Louis, Missouri, United States, 63141
Saint John's Mercy Medical Center
Saint Louis, Missouri, United States, 63141
Saint Louis Cancer and Breast Institute-South City
Saint Louis, Missouri, United States, 63109
Missouri Baptist Medical Center
Saint Louis, Missouri, United States, 63131
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Saint Louis University Hospital
Saint Louis, Missouri, United States, 63110
Mercy Hospital Springfield
Springfield, Missouri, United States, 65804
United States, Montana
Montana Cancer Consortium CCOP
Billings, Montana, United States, 59101
Billings Clinic
Billings, Montana, United States, 59107-7000
Hematology-Oncology Centers of the Northern Rockies PC
Billings, Montana, United States, 59102
Saint Vincent Healthcare
Billings, Montana, United States, 59101
Bozeman Deaconess Hospital
Bozeman, Montana, United States, 59715
Bozeman Deaconess Cancer Center
Bozeman, Montana, United States, 59715
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, United States, 59701
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, United States, 59405
Great Falls Clinic
Great Falls, Montana, United States, 59405
Northern Montana Hospital
Havre, Montana, United States, 59501
Saint Peter's Community Hospital
Helena, Montana, United States, 59601
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Glacier Oncology PLLC
Kalispell, Montana, United States, 59901
Kalispell Medical Oncology
Kalispell, Montana, United States, 59901
Saint Patrick Hospital - Community Hospital
Missoula, Montana, United States, 59802
Montana Cancer Specialists
Missoula, Montana, United States, 59802
United States, Nebraska
Saint Francis Medical Center
Grand Island, Nebraska, United States, 68803
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, Nevada
Nevada Cancer Research Foundation CCOP
Las Vegas, Nevada, United States, 89106
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States, 89102
United States, New Hampshire
New Hampshire Oncology-Hematology PA
Concord, New Hampshire, United States, 03301
New Hampshire Oncology Hematology Associates
Hooksett, New Hampshire, United States, 03106
LRGHealthcare-Lakes Region General Hospital
Laconia, New Hampshire, United States, 03246
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Norris Cotton Cancer Center-Manchester
Manchester, New Hampshire, United States, 03102
United States, New Jersey
Cooper Hospital University Medical Center
Camden, New Jersey, United States, 08103
Veterans Adminstration New Jersey Health Care System
East Orange, New Jersey, United States, 07018-1095
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County
Mount Holly, New Jersey, United States, 08060
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Virtua West Jersey Hospital Voorhees
Voorhees, New Jersey, United States, 08043
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87106
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106
Memorial Medical Center - Las Cruces
Las Cruces, New Mexico, United States, 88011
United States, New York
Montefiore Medical Center - Moses Campus
Bronx, New York, United States, 10467-2490
Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Hematology Oncology Associates of Central New York PC-East Syracuse
East Syracuse, New York, United States, 13057
North Shore University Hospital
Manhasset, New York, United States, 11030
North Shore-LIJ Health System CCOP
Manhasset, New York, United States, 11030
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
North Shore-LIJ Health System/Center for Advanced Medicine
New Hyde Park, New York, United States, 11040
New York University Langone Medical Center
New York, New York, United States, 10016
Mount Sinai Medical Center
New York, New York, United States, 10029
Weill Medical College of Cornell University
New York, New York, United States, 10065
University of Rochester
Rochester, New York, United States, 14642
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
State University of New York Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Carolina
Mission Hospital-Memorial Campus
Asheville, North Carolina, United States, 28801
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Wayne Memorial Hospital
Goldsboro, North Carolina, United States, 27534
East Carolina University
Greenville, North Carolina, United States, 27858
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, United States, 28791
Kinston Medical Specialists PA
Kinston, North Carolina, United States, 28501
Iredell Memorial Hospital
Statesville, North Carolina, United States, 28677
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Mary Rutan Hospital
Bellefontaine, Ohio, United States, 43311
Aultman Health Foundation
Canton, Ohio, United States, 44710
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
Case Western Reserve University
Cleveland, Ohio, United States, 44106
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Mount Carmel Health Center West
Columbus, Ohio, United States, 43222
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Doctors Hospital
Columbus, Ohio, United States, 43228
Grant Medical Center
Columbus, Ohio, United States, 43215
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Columbus CCOP
Columbus, Ohio, United States, 43215
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Grandview Hospital
Dayton, Ohio, United States, 45405
Dayton CCOP
Dayton, Ohio, United States, 45420
Samaritan North Health Center
Dayton, Ohio, United States, 45415
Good Samaritan Hospital - Dayton
Dayton, Ohio, United States, 45406
Miami Valley Hospital
Dayton, Ohio, United States, 45409
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Blanchard Valley Hospital
Findlay, Ohio, United States, 45840
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, United States, 45005-1066
Wayne Hospital
Greenville, Ohio, United States, 45331
Kettering Medical Center
Kettering, Ohio, United States, 45429
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
Marietta Memorial Hospital
Marietta, Ohio, United States, 45750
Knox Community Hospital
Mount Vernon, Ohio, United States, 43050
Licking Memorial Hospital
Newark, Ohio, United States, 43055
Springfield Regional Medical Center
Springfield, Ohio, United States, 45505
Upper Valley Medical Center
Troy, Ohio, United States, 45373
Saint Ann's Hospital
Westerville, Ohio, United States, 43081
Clinton Memorial Hospital
Wilmington, Ohio, United States, 45177
Greene Memorial Hospital
Xenia, Ohio, United States, 45385
Genesis HealthCare System
Zanesville, Ohio, United States, 43701
United States, Pennsylvania
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States, 19010
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-2001
Easton Hospital
Easton, Pennsylvania, United States, 18042
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, United States, 18201
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Lewistown Hospital
Lewistown, Pennsylvania, United States, 17044
Paoli Memorial Hospital
Paoli, Pennsylvania, United States, 19301
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Pottstown Memorial Medical Center
Pottstown, Pennsylvania, United States, 19464
Mount Nittany Medical Center
State College, Pennsylvania, United States, 16803
Geisinger Medical Group
State College, Pennsylvania, United States, 16801
Geisinger Wyoming Valley
Wilkes-Barre, Pennsylvania, United States, 18711
Mainline Health CCOP
Wynnewood, Pennsylvania, United States, 19096
Lankenau Medical Center
Wynnewood, Pennsylvania, United States, 19096
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Greenville Health System Cancer Institute-Easley
Easley, South Carolina, United States, 29640
McLeod Regional Medical Center
Florence, South Carolina, United States, 29506
Greenville Health System Cancer Institute-Faris
Greenville, South Carolina, United States, 29605
Greenville Memorial Hospital
Greenville, South Carolina, United States, 29605
Greenville Health System Cancer Institute-Butternut
Greenville, South Carolina, United States, 29605
Greenville Health System Cancer Institute-Andrews
Greenville, South Carolina, United States, 29605
Greenville Health System Cancer Institute/Eastside
Greenville, South Carolina, United States, 29615
Self Regional Healthcare
Greenwood, South Carolina, United States, 29646
Cancer Centers of the Carolinas-Greer Medical Oncology
Greer, South Carolina, United States, 29650
Greenville Health System Cancer Institute-Greer
Greer, South Carolina, United States, 29650
Greenville Health System Cancer Institute-Seneca
Seneca, South Carolina, United States, 29672
Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina, United States, 29307
United States, Tennessee
Thompson Cancer Survival Center
Knoxville, Tennessee, United States, 37916
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75246
United States, Vermont
Central Vermont Medical Center/National Life Cancer Treatment
Berlin, Vermont, United States, 05602
University of Vermont
Burlington, Vermont, United States, 05401
Norris Cotton Cancer Center-North
Saint Johnsbury, Vermont, United States, 05819
United States, Virginia
Danville Regional Medical Center
Danville, Virginia, United States, 24541
Memorial Hospital Of Martinsville
Martinsville, Virginia, United States, 24115
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
United States, West Virginia
West Virginia University Healthcare
Morgantown, West Virginia, United States, 26506
Wheeling Hospital
Wheeling, West Virginia, United States, 26003
United States, Wisconsin
Marshfield Clinic-Chippewa Center
Chippewa Falls, Wisconsin, United States, 54729
Marshfield Clinic Cancer Center at Sacred Heart
Eau Claire, Wisconsin, United States, 54701
Sacred Heart Hospital
Eau Claire, Wisconsin, United States, 54701
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301
Saint Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301-3526
UW Cancer Center Johnson Creek
Johnson Creek, Wisconsin, United States, 53038
Gundersen Lutheran
La Crosse, Wisconsin, United States, 54601
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Holy Family Memorial Hospital
Manitowoc, Wisconsin, United States, 54221
Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Saint Joseph's Hospital
Marshfield, Wisconsin, United States, 54449
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, United States, 54548
Oconomowoc Memorial Hospital-ProHealth Care Inc
Oconomowoc, Wisconsin, United States, 53066-3896
Green Bay Oncology - Oconto Falls
Oconto Falls, Wisconsin, United States, 54154
Marshfield Clinic at James Beck Cancer Center
Rhinelander, Wisconsin, United States, 54501
Saint Mary's Hospital
Rhinelander, Wisconsin, United States, 54501
Marshfield Clinic-Rice Lake Center
Rice Lake, Wisconsin, United States, 54868
Saint Nicholas Hospital
Sheboygan, Wisconsin, United States, 53081
Marshfield Clinic Cancer Care at Saint Michael's Hospital
Stevens Point, Wisconsin, United States, 54481
Saint Michael's Hospital
Stevens Point, Wisconsin, United States, 54481
Green Bay Oncology - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States, 54235
Waukesha Memorial Hospital - ProHealth Care
Waukesha, Wisconsin, United States, 53188
Marshfield Clinic - Weston Center
Weston, Wisconsin, United States, 54476
Diagnostic and Treatment Center
Weston, Wisconsin, United States, 54476
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, United States, 54494
United States, Wyoming
Rocky Mountain Oncology
Casper, Wyoming, United States, 82609
Welch Cancer Center
Sheridan, Wyoming, United States, 82801
Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Nova Scotia
QEII Health Sciences Centre/Capital District Health Authority
Halifax, Nova Scotia, Canada, B3H 1V8
Canada, Ontario
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8V 5C2
University Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
CSSS Champlain-Charles Le Moyne
Greenfield Park, Quebec, Canada, J4V 2H1
McGill University Health Centre at Royal Victoria Hospital
Montreal, Quebec, Canada, H3A 1A1
Le Centre hospitalier affilie universitaire de Quebec-Saint Sacrement
Quebec City, Quebec, Canada, G1S 4L8
Sponsors and Collaborators
Southwest Oncology Group
Eastern Cooperative Oncology Group
NCIC Clinical Trials Group
Investigators
Principal Investigator: John Byrd Alliance for Clinical Trials in Oncology
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00602459     History of Changes
Other Study ID Numbers: NCI-2009-00441, NCI-2009-00441, NCIC CTG C10404, SWOG C10404, CAN-NCIC-CL3, CALGB-10404, CDR0000584205, ECOG 10404, ECOG-10404, NCIC-CTG-C10404, SWOG-C10404, CALGB 10404, CALGB-10404, U10CA180821, U10CA031946
Study First Received: January 23, 2008
Last Updated: October 21, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Cyclophosphamide
Fludarabine
Fludarabine phosphate
Lenalidomide
Rituximab
Thalidomide
Vidarabine
Alkylating Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antiviral Agents
Growth Inhibitors
Growth Substances

ClinicalTrials.gov processed this record on October 21, 2014