Rituximab and Alemtuzumab in Treating Older Patients With Progressive Chronic Lymphocytic Leukemia

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by National Cancer Institute (NCI)
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01013961
First received: November 13, 2009
Last updated: December 4, 2012
Last verified: December 2012
  Purpose

RATIONALE: Monoclonal antibodies, such as rituximab and alemtuzumab, 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. Giving rituximab together with alemtuzumab may kill more cancer cells.

PURPOSE: This randomized phase II trial is studying two different doses of rituximab to compare how well they work when given together with alemtuzumab in treating older patients with progressive chronic lymphocytic leukemia.


Condition Intervention Phase
Leukemia
Biological: alemtuzumab
Biological: rituximab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Phase II Randomized Trial Comparing Standard and Low Dose Rituximab: Initial Treatment of Progressive Chronic Lymphocytic Leukemia in Elderly Patients Using Alemtuzumab, and Rituximab

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Rate of complete and overall response [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity as assessed by NCI CTC v4.0 criteria [ Designated as safety issue: Yes ]

Estimated Enrollment: 90
Study Start Date: October 2010
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive alemtuzumab subcutaneously (SC) on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and standard-dose rituximab IV on days 8, 15, 22, and 29 in course 1. In courses 2 and 3, patients receive alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 and standard-dose rituximab IV on days 3, 10, 17, and 24. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Biological: alemtuzumab
Given IV
Biological: rituximab
Given IV
Experimental: Arm II
Patients receive alemtuzumab as in arm I. Patients also receive low-dose rituximab IV on days 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 in course 1 and on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 in courses 2 and 3. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Biological: alemtuzumab
Given IV
Biological: rituximab
Given IV

Detailed Description:

OBJECTIVES:

Primary

  • To compare the rate of complete and overall response in elderly patients with progressive chronic lymphocytic leukemia (CLL) treated with one of two doses of rituximab combined with alemtuzumab to determine if the use of modified-dose rituximab significantly affects outcome.

Secondary

  • To monitor and assess toxicity of these regimens.
  • To determine the overall and progression-free survival, time to clinical response, time to next treatment, and duration of response in patients treated with these regimens
  • To assess the correlation between risk stratification prognostic markers (i.e., CD38, ZAP-70, FISH, and IgVH mutation) and clinical outcome.
  • To assess response to these regimens using both the NCI-WG 96 criteria and an expanded definition of response for patients in complete remission, including immunohistochemical examination of the bone marrow and sensitive flow cytometry (4-6 color) of blood for minimal residual disease and CT scans for residual adenopathy.
  • To determine the mechanism of action of rituximab and alemtuzumab and to determine mechanisms of resistance of a subpopulation of CLL cells to these drugs.

OUTLINE: This is a multicenter study. Patients are stratified according to FISH risk (low [13q14-] vs intermediate [12+, no abnormality, all other abnormalities] vs high [17p13-,11q22-]). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive alemtuzumab subcutaneously (SC) on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and standard-dose rituximab IV on days 8, 15, 22, and 29 in course 1. In courses 2 and 3, patients receive alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 and standard-dose rituximab IV on days 3, 10, 17, and 24. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive alemtuzumab as in arm I. Patients also receive low-dose rituximab IV on days 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 in course 1 and on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 in courses 2 and 3. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

Blood and bone marrow samples are collected periodically for cytogenetic and biomarker analysis.

After completion of study therapy, patients are followed up periodically for 5 years.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of chronic lymphocytic leukemia (CLL) meeting the following criteria:

    • Minimum threshold peripheral lymphocyte count of 5 x 10^9/L (CLL variant) OR palpable adenopathy > 1 cm or palpable splenomegaly (SLL variant)
    • Immunophenotypic demonstrations of a population of B-lymphocytes (as defined by CD19+) that are monoclonal (by light-chain exclusion) AND have ≥ 3 of the following characteristics:

      • CD5+
      • CD23+
      • Dim surface light chain expression
      • Dim surface CD20 expression
    • FISH analysis is negative for IGH/CCND1 and/or immunostaining is negative for cyclin D1 expression (to exclude mantle cell lymphoma)
  • Has progressive, symptomatic CLL, defined by at least one of the following:

    • Weight loss > 10% within the past 6 months attributable to progressive CLL (grade 2 or higher)
    • Extreme fatigue attributable to progressive CLL (grade 3 or higher)
    • Fevers > 100.5° F for 2 weeks without evidence of infection (grade 1 or higher)
    • Night sweats without evidence of infection (drenching)
    • Evidence of progressive bone marrow failure with hemoglobin < 11 g/dL or platelet count < 100 x 10^9/L
    • Rapidly progressive lymphadenopathy for which the largest node is ≤ 5 cm in any dimension

      • Largest lymph nodes involved in the neck, axilla, and groin need to be measured and followed for response
  • No massive splenomegaly > 6 cm below left costal margin, at rest, on clinical examination
  • No lymphadenopathy > 5 cm in any diameter

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-3
  • Creatinine ≤ 2 times upper limit of normal (ULN)
  • Total bilirubin ≤ 1.5 times ULN
  • AST ≤ 3.0 times ULN (unless due to CLL involvement of the liver)
  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 12 months after completion of study therapy
  • None of the following comorbid conditions:

    • New York Heart Association class III or IV heart disease
    • Recent myocardial infarction (within the past month)
    • Uncontrolled infection
    • HIV/AIDS
    • Serological evidence of active hepatitis B infection (HBsAg or HBeAg positive)
    • Positive hepatitis C serology
  • No active autoimmune hemolytic anemia, immune thrombocytopenia, or pure red blood cell aplasia
  • No other active primary malignancy requiring treatment or that limits survival to ≤ 2 years, except for in situ carcinoma of the cervix or breast or non-metastatic basal cell or squamous cell carcinoma of the skin

PRIOR CONCURRENT THERAPY:

  • No prior treatment for CLL
  • More than 4 weeks since prior major surgery
  • No concurrent continuous systemic corticosteroids

    • Prior corticosteroids are allowed but not at time of pre-registration to the study
  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: NCT01013961

  Hide Study Locations
Locations
United States, Arizona
Mayo Clinic Scottsdale Recruiting
Scottsdale, Arizona, United States, 85259-5499
Contact: Clinical Trials Office - All Mayo Clinic Locations    507-538-7623      
United States, Florida
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital Recruiting
Fort Lauderdale, Florida, United States, 33308
Contact: Clinical Trials Office - Michael and Dianne Bienes Comprehensi    954-776-3239      
Ella Milbank Foshay Cancer Center at Jupiter Medical Center Recruiting
Jupiter, Florida, United States, 33458
Contact: Clinical Trials Office - Ella Milbank Foshay Cancer Center    561-745-5768      
CCOP - Mount Sinai Medical Center Recruiting
Miami Beach, Florida, United States, 33140
Contact: Michael Schwartz, MD    305-535-3310      
United States, Georgia
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler Recruiting
Savannah, Georgia, United States, 31405
Contact: O. George Negrea, MD    912-692-2000      
United States, Illinois
Rush-Copley Cancer Care Center Recruiting
Aurora, Illinois, United States, 60504
Contact: Ronnie F. Luyun    630-499-2400      
St. Joseph Medical Center Recruiting
Bloomington, Illinois, United States, 61701
Contact: Nguyet A. Le-Lindqwister    309-662-3311      
Illinois CancerCare - Bloomington Recruiting
Bloomington%, Illinois, United States, 61701
Contact: Nguyet A. Le-Lindqwister    309-662-2102      
Graham Hospital Recruiting
Canton, Illinois, United States, 61520
Contact: Nguyet A. Le-Lindqwister    309-647-5240      
Illinois CancerCare - Canton Recruiting
Canton, Illinois, United States, 61520
Contact: Nguyet A. Le-Lindqwister    309-647-5240      
Memorial Hospital Recruiting
Carthage, Illinois, United States, 62321
Contact: Nguyet A. Le-Lindqwister    217-357-3131      
Illinois CancerCare - Carthage Recruiting
Carthage, Illinois, United States, 62321
Contact: Nguyet A. Le-Lindqwister    217-357-6877      
University of Chicago Cancer Research Center Recruiting
Chicago, Illinois, United States, 60637-1470
Contact: Clinical Trials Office - University of Chicago Cancer Research    773-834-7424      
Illinois CancerCare - Eureka Recruiting
Eureka, Illinois, United States, 61530
Contact: Nguyet A. Le-Lindqwister    309-467-2371      
Eureka Community Hospital Recruiting
Eureka, Illinois, United States, 61530
Contact: Nguyet A. Le-Lindqwister    309-467-2371      
Galesburg Clinic, PC Recruiting
Galesburg, Illinois, United States, 61401
Contact: Nguyet A. Le-Lindqwister    309-344-1000      
Illinois CancerCare - Havana Recruiting
Havana, Illinois, United States, 62644
Contact: Nguyet A. Le-Lindqwister    309-543-8557      
Illinois CancerCare - Kewanee Clinic Recruiting
Kewanee, Illinois, United States, 61443
Contact: Nguyet A. Le-Lindqwister    309-852-0598      
McDonough District Hospital Recruiting
Macomb, Illinois, United States, 61455
Contact: Nguyet A. Le-Lindqwister    309-833-4101      
Illinois CancerCare - Macomb Recruiting
Macomb, Illinois, United States, 61455
Contact: Nguyet A. Le-Lindqwister    309-833-3503      
OSF Holy Family Medical Center Recruiting
Monmouth, Illinois, United States, 61462
Contact: Nguyet A. Le-Lindqwister    309-734-3141      
Illinois CancerCare - Monmouth Recruiting
Monmouth, Illinois, United States, 61462
Contact: Nguyet A. Le-Lindqwister    309-734-3141      
Community Cancer Center Recruiting
Normal, Illinois, United States, 61761
Contact: Nguyet A. Le-Lindqwister    309-451-8500      
BroMenn Regional Medical Center Recruiting
Normal, Illinois, United States, 61761
Contact: Nguyet A. Le-Lindqwister    309-454-1400      
Illinois CancerCare - Community Cancer Center Recruiting
Normal, Illinois, United States, 61761
Contact: Nguyet A. Le-Lindqwister    309-662-2102      
Community Hospital of Ottawa Recruiting
Ottawa, Illinois, United States, 61350
Contact: Nguyet A. Le-Lindqwister    815-433-3100      
Oncology Hematology Associates of Central Illinois, PC - Ottawa Recruiting
Ottawa, Illinois, United States, 61350
Contact: Nguyet A. Le-Lindqwister    815-431-9270      
Cancer Treatment Center at Pekin Hospital Recruiting
Pekin, Illinois, United States, 61554
Contact: Nguyet A. Le-Lindqwister    309-353-0512      
Illinois CancerCare - Pekin Recruiting
Pekin, Illinois, United States, 61603
Contact: Nguyet A. Le-Lindqwister    309-353-0214      
Oncology Hematology Associates of Central Illinois, PC - Peoria Recruiting
Peoria, Illinois, United States, 61615
Contact: Nguyet A. Le-Lindqwister    309-243-3000      
CCOP - Illinois Oncology Research Association Recruiting
Peoria, Illinois, United States, 61615
Contact: Nguyet A. Le-Lindqwister    309-243-3605      
Proctor Hospital Recruiting
Peoria, Illinois, United States, 61614
Contact: Nguyet A. Le-Lindqwister    309-691-1000      
OSF St. Francis Medical Center Recruiting
Peoria, Illinois, United States, 61637
Contact: Nguyet A. Le-Lindqwister    309-655-2000      
Methodist Medical Center of Illinois Recruiting
Peoria, Illinois, United States, 61636
Contact: Clinical Trials Office - Methodist Medical Center of Illinois    309-243-3000      
Illinois Valley Community Hospital Recruiting
Peru, Illinois, United States, 61354
Contact: Nguyet A. Le-Lindqwister    815-223-3000      
Illinois CancerCare - Peru Recruiting
Peru, Illinois, United States, 61354
Contact: Nguyet A. Le-Lindqwister    815-780-3185      
Illinois CancerCare - Princeton Recruiting
Princeton, Illinois, United States, 61356
Contact: Nguyet A. Le-Lindqwister    815-875-3010      
Swedish-American Regional Cancer Center Recruiting
Rockford, Illinois, United States, 61104-2315
Contact: Clinical Trials Office - Swedish-American Regional Cancer Cent    815-489-4413      
Illinois CancerCare - Spring Valley Recruiting
Spring Valley, Illinois, United States, 61362
Contact: Nguyet A. Le-Lindqwister    815-664-1487      
CCOP - Carle Cancer Center Recruiting
Urbana, Illinois, United States, 61801
Contact: Clinical Trials Office - CCOP - Carle Cancer Center    800-446-5532      
United States, Indiana
St. Francis Hospital and Health Centers - Beech Grove Campus Recruiting
Beech Grove, Indiana, United States, 46107
Contact: Howard M. Gross, MD    937-832-1093      
Reid Hospital & Health Care Services Recruiting
Richmond, Indiana, United States, 47374
Contact: Howard M. Gross, MD    937-832-1093      
United States, Iowa
McFarland Clinic, PC Recruiting
Ames, Iowa, United States, 50010
Contact: Clinical Trials Office - McFarland Clinic, PC    515-239-2621      
Cedar Rapids Oncology Associates Recruiting
Cedar Rapids, Iowa, United States, 52403
Contact: Clinical Trials Office - Cedar Rapids Oncology Associates    319-363-2690      
Mercy Regional Cancer Center at Mercy Medical Center Recruiting
Cedar Rapids, Iowa, United States, 52403
Contact: Deborah W. Wilbur    319-398-6011      
Mercy Cancer Center at Mercy Medical Center - North Iowa Recruiting
Mason City, Iowa, United States, 50401
Contact: Clinical Trials Office - Mercy Cancer Center at Mercy Medical    641-422-6304      
Mercy Medical Center - Sioux City Recruiting
Sioux City, Iowa, United States, 51102
Contact: Donald B. Wender, MD, PhD    712-252-0088      
Siouxland Hematology-Oncology Associates, LLP Recruiting
Sioux City, Iowa, United States, 51101
Contact: Donald B. Wender, MD, PhD    712-252-0088      
St. Luke's Regional Medical Center Recruiting
Sioux City, Iowa, United States, 51104
Contact: Donald B. Wender, MD, PhD    712-252-0088      
United States, Louisiana
Tulane Cancer Center Office of Clinical Research Recruiting
Alexandria, Louisiana, United States, 71315-3198
Contact: Clinical Trials Office - Tulane Cancer Center    504-988-6121      
Hematology-Oncology Clinic Recruiting
Baton Rouge, Louisiana, United States, 70809
Contact: Hana F. Safah    225-767-0822      
Feist-Weiller Cancer Center at Louisiana State University Health Sciences Recruiting
Shreveport, Louisiana, United States, 71130-3932
Contact: Clinical Trials Office - Feist-Weiller Cancer Center at Louisi    318-813-1412      
United States, Michigan
Borgess Medical Center Recruiting
Kalamazoo, Michigan, United States, 49001
Contact: Raymond S. Lord, MD    269-373-7458      
West Michigan Cancer Center Recruiting
Kalamazoo, Michigan, United States, 49007-3731
Contact: Clinical Trials Office - West Michigan Cancer Center    269-373-7458      
Bronson Methodist Hospital Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Raymond S. Lord, MD    269-373-7458      
Upper Michigan Cancer Center at Marquette General Hospital Recruiting
Marquette, Michigan, United States, 49855
Contact: Clinical Trials Office - Upper Michigan Cancer Center at Marqu    906-225-3467      
United States, Minnesota
Mayo Clinic Cancer Center Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Office - All Mayo Clinic Locations    507-538-7623      
United States, Missouri
Central Care Cancer Center at Carrie J. Babb Cancer Center Recruiting
Bolivar, Missouri, United States, 65613
Contact: Robert L. Carolla    417-326-7200      
Skaggs Cancer Center at Skaggs Regional Medical Center Recruiting
Branson, Missouri, United States, 65616
Contact: Robert L. Carolla    417-348-8032      
Southeast Cancer Center Recruiting
Cape Girardeau, Missouri, United States, 63703
Contact: Alan P. Lyss, MD    314-996-5514      
Goldschmidt Cancer Center Recruiting
Jefferson City, Missouri, United States, 65109
Contact: Alan P. Lyss, MD    314-996-5514      
Mercy Clinic Cancer and Hematology - Rolla Recruiting
Rolla, Missouri, United States, 65401
Contact: Robert L. Carolla    573-458-6379      
Phelps County Regional Medical Center Recruiting
Rolla, Missouri, United States, 65401
Contact: Robert L. Carolla    573-458-8899      
Missouri Baptist Cancer Center Recruiting
Saint Louis, Missouri, United States, 63131
Contact: Alan P. Lyss, MD    314-996-5514      
Hulston Cancer Center at Cox Medical Center South Recruiting
Springfield, Missouri, United States, 65807
Contact: Robert L. Carolla    417-269-5257      
CCOP - Cancer Research for the Ozarks Recruiting
Springfield, Missouri, United States, 65802
Contact: Robert L. Carolla    417-269-4520      
St. John's Regional Health Center Recruiting
Springfield, Missouri, United States, 65804
Contact: Robert L. Carolla    417-820-2000      
United States, Nevada
CCOP - Nevada Cancer Research Foundation Recruiting
Las Vegas, Nevada, United States, 89106
Contact: John A. Ellerton, MD, CM    702-384-0013      
United States, North Carolina
Randolph Hospital Recruiting
Asheboro, North Carolina, United States, 27203-5400
Contact: Clinical Trails Office - Randolph Hospital    336-832-0821      
Wayne Memorial Hospital, Incorporated Recruiting
Goldsboro, North Carolina, United States, 27534
Contact: James N. Atkins, MD    919-580-0000      
Moses Cone Regional Cancer Center at Wesley Long Community Hospital Recruiting
Greensboro, North Carolina, United States, 27403-1198
Contact: Clinical Trials Office - Moses Cone Regional Cancer Center at    336-621-8374      
Pardee Memorial Hospital Recruiting
Hendersonville, North Carolina, United States, 28791
Contact: James E. Radford, MD    828-692-8045      
Kinston Medical Specialists Recruiting
Kinston, North Carolina, United States, 28501
Contact: Peter R. Watson, MD    252-559-2200ext.201      
Annie Penn Cancer Center Recruiting
Reidsville, North Carolina, United States, 27320
Contact: Clinical Trials Office - Annie Penn Cancer Center    336-621-8374      
Iredell Memorial Hospital Recruiting
Statesville, North Carolina, United States, 28677
Contact: Ruby A. Grimm, MD    704-873-2219      
United States, North Dakota
Medcenter One Hospital Cancer Care Center Recruiting
Bismarck, North Dakota, United States, 58501
Contact: John T. Reynolds    701-323-5741      
Mid Dakota Clinic, PC Recruiting
Bismarck, North Dakota, United States, 58501
Contact: Clinical Trials Office - Mid Dakota Clinic, PC    701-530-6950      
St. Alexius Medical Center Cancer Center Recruiting
Bismarck, North Dakota, United States, 58502
Contact: Clinical Trials Office - St. Alexius Medical Center Cancer Cen    701-530-6950      
United States, Ohio
Aultman Cancer Center at Aultman Hospital Recruiting
Canton, Ohio, United States, 44710-1799
Contact: Clinical Trials Office - Aultman Cancer Center at Aultman Hosp    330-363-6891      
David L. Rike Cancer Center at Miami Valley Hospital Recruiting
Dayton, Ohio, United States, 45409
Contact: Clinical Trials Office - David L. Rike Cancer Center at Miami    937-208-2079      
CCOP - Dayton Recruiting
Dayton, Ohio, United States, 45420
Contact: Howard M. Gross, MD    937-832-1093      
Grandview Hospital Recruiting
Dayton, Ohio, United States, 45405
Contact: Howard M. Gross, MD    937-832-1093      
Good Samaritan Hospital Recruiting
Dayton, Ohio, United States, 45406
Contact: Howard M. Gross, MD    937-832-1093      
Samaritan North Cancer Care Center Recruiting
Dayton, Ohio, United States, 45415
Contact: Howard M. Gross, MD    937-832-1093      
Blanchard Valley Medical Associates Recruiting
Findlay, Ohio, United States, 45840
Contact: Howard M. Gross, MD    937-832-1093      
Middletown Regional Hospital Recruiting
Franklin, Ohio, United States, 45005-1066
Contact: Howard M. Gross, MD    937-832-1093      
Wayne Hospital Recruiting
Greenville, Ohio, United States, 45331
Contact: Howard M. Gross, MD    937-832-1093      
Charles F. Kettering Memorial Hospital Recruiting
Kettering, Ohio, United States, 45429
Contact: Clinical Trials Office - Charles F. Kettering Memorial Hospita    937-298-3399 ext. 57556      
St. Rita's Medical Center Recruiting
Lima, Ohio, United States, 45801
Contact: Clinical Trials Office - St. Rita's Medical Center    419-226-9617      
UVMC Cancer Care Center at Upper Valley Medical Center Recruiting
Troy, Ohio, United States, 45373-1300
Contact: Clinical Trials Office - UVMC Cancer Care Center at Upper Vall    937-440-4842      
Ruth G. McMillan Cancer Center at Greene Memorial Hospital Recruiting
Xenia, Ohio, United States, 45385
Contact: Howard M. Gross, MD    937-832-1093      
United States, Pennsylvania
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033-0850
Contact: Clinical Trials Office - Penn State Hershey Cancer Institute a    717-531-3779    CTO@hmc.psu.edu   
Lewistown Hospital Recruiting
Lewistown, Pennsylvania, United States, 17044
Contact: David F. Claxton    717-242-7143      
Mercy Hospital Cancer Center - Scranton Recruiting
Scranton, Pennsylvania, United States, 18501
Contact: Martin B. Hyzinski, MD    570-558-3020      
Hematology and Oncology Associates of Northeastern Pennsylvania Recruiting
Scranton, Pennsylvania, United States, 18510
Contact: Martin B. Hyzinski, MD    570-558-3020      
Mount Nittany Medical Center Recruiting
State College, Pennsylvania, United States, 16803
Contact: David F. Claxton    814-231-7000      
United States, Tennessee
U.T. Medical Center Cancer Institute Recruiting
Knoxville, Tennessee, United States, 37920-6999
Contact: Clinical Trials Office - U.T. Medical Center Cancer Institute    865-544-9773      
United States, Virginia
Danville Regional Medical Center Recruiting
Danville, Virginia, United States, 24541
Contact: Clinical Trials Office - Danville Regional Medical Center    434-799-3753      
United States, Wisconsin
UW Cancer Center Johnson Creek Recruiting
Johnson Creek, Wisconsin, United States, 53038
Contact: Julie E. Chang    920-699-3500      
Gundersen Lutheran Center for Cancer and Blood Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Clinical Trials Office - Gundersen Lutheran Cancer Center    608-775-2385    cancerctr@gundluth.org   
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center Recruiting
Madison, Wisconsin, United States, 53792-6164
Contact: Clinical Trials Office - University of Wisconsin Paul P. Carbo    608-262-5223      
Riverview UW Cancer Center at Riverview Hospital Recruiting
Wisconsin Rapids, Wisconsin, United States, 54494
Contact: Ron J. Kirschling, MD, FACP    715-421-7442      
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Study Chair: Clive S. Zent, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Robert L. Comis, ECOG Group Chair's Office
ClinicalTrials.gov Identifier: NCT01013961     History of Changes
Other Study ID Numbers: CDR0000659098, ECOG-E1908
Study First Received: November 13, 2009
Last Updated: December 4, 2012
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Alemtuzumab
Rituximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 28, 2014