Fludarabine With or Without Cyclophosphamide in Treating Patients With Chronic Lymphocytic Leukemia

June 14, 2023 updated by: Eastern Cooperative Oncology Group

Phase III Randomized Trial of Fludarabine and Cyclophosphamide Versus Fludarabine for Previously Untreated Chronic Lymphocytic Leukemia

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known whether combining cyclophosphamide with fludarabine is more effective than fludarabine alone in treating chronic lymphocytic leukemia.

PURPOSE: Randomized phase III trial to study the effectiveness of fludarabine with or without cyclophosphamide in treating patients who have chronic lymphocytic leukemia that has not been treated previously.

Study Overview

Status

Completed

Conditions

Leukemia

Intervention / Treatment

Detailed Description

OBJECTIVES:

Compare the efficacy of fludarabine with or without cyclophosphamide in terms of complete remission rate and overall survival in patients with previously untreated B cell chronic lymphocytic leukemia (CLL).
Compare the toxicities of these 2 regimens in this patient population.
Determine whether the expression of proteins specifically implicated in the regulation of DNA damage induced apoptosis of lymphoid cells (i.e., p53; mdm2; GST; Bcl-2; Mcl-1; Bax; p27; and caspase-3) correlates with response to chemotherapy in these patients.
Determine whether there is a relationship between clinical response or resistance and differential expression of genes in the CLL cells either at initiation of therapy or following relapse and progression.
Correlate mutations in immunoglobulin heavy chain variable region genes with clinical response or resistance in this patient population.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to stage of disease (O-II vs III-IV). Patients are randomized to one of two treatment arms.

Arm I: Patients receive fludarabine IV over 30 minutes on days 1-5.
Arm II: Patients receive fludarabine as in arm I plus cyclophosphamide IV over 1 hour on day 1.

Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months until disease progression.

PROJECTED ACCRUAL: A total of 280 patients will be accrued for this study over 2 to 2.5 years.

Study Type

Interventional

Enrollment (Estimated)

280

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- Quebec
  - Montreal, Quebec, Canada, H2W 1S6
    - McGill University
Puerto Rico
- - San Juan, Puerto Rico, 00936-5067
    - University of Puerto Rico School of Medicine Medical Sciences Campus
South Africa
- - Pretoria, South Africa, 0001
    - Pretoria Academic Hospital
United States
- Alabama
  - Anniston, Alabama, United States, 36207
    - Northeast Alabama Regional Medical Center
  - Birmingham, Alabama, United States, 35294-3300
    - University of Alabama at Birmingham Comprehensive Cancer Center
  - Mobile, Alabama, United States, 36688
    - MBCCOP - Gulf Coast
- Arizona
  - Phoenix, Arizona, United States, 85006-2726
    - CCOP - Western Regional, Arizona
  - Phoenix, Arizona, United States, 85012
    - Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
  - Tucson, Arizona, United States, 85723
    - Veterans Affairs Medical Center - Tucson
  - Tucson, Arizona, United States, 85724
    - Arizona Cancer Center at University of Arizona Health Sciences Center
- Arkansas
  - Little Rock, Arkansas, United States, 72205
    - University of Arkansas for Medical Sciences
  - Little Rock, Arkansas, United States, 72205
    - Veterans Affairs Medical Center - Little Rock (McClellan)
- California
  - Duarte, California, United States, 91010-0269
    - City of Hope Comprehensive Cancer Center
  - La Jolla, California, United States, 92093-0658
    - Rebecca and John Moores UCSD Cancer Center
  - Los Angeles, California, United States, 90048
    - Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
  - Los Angeles, California, United States, 90095-1781
    - Jonsson Comprehensive Cancer Center, UCLA
  - Los Angeles, California, United States, 90033
    - USC/Norris Comprehensive Cancer Center and Hospital
  - Martinez, California, United States, 94553
    - Veterans Affairs Outpatient Clinic - Martinez
  - Oakland, California, United States, 94609-3305
    - CCOP - Bay Area Tumor Institute
  - Orange, California, United States, 92868
    - Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
  - Sacramento, California, United States, 95817
    - University of California Davis Cancer Center
  - San Diego, California, United States, 92161
    - Veterans Affairs Medical Center - San Diego
  - San Francisco, California, United States, 94121
    - Veterans Affairs Medical Center - San Francisco
  - Santa Rosa, California, United States, 95403
    - CCOP - Santa Rosa Memorial Hospital
  - Travis Air Force Base, California, United States, 94535
    - David Grant Medical Center
- Colorado
  - Aurora, Colorado, United States, 80010
    - University of Colorado Cancer Center at University of Colorado Health Sciences Center
  - Aurora, Colorado, United States, 80012-0000
    - Medical Center of Aurora - South Campus
  - Boulder, Colorado, United States, 80301-9019
    - Boulder Community Hospital
  - Colorado Springs, Colorado, United States, 80933
    - Penrose Cancer Center
  - Denver, Colorado, United States, 80210
    - Porter Adventist Hospital
  - Denver, Colorado, United States, 80218
    - Presbyterian-St Luke's Medical Center
  - Denver, Colorado, United States, 80224
    - CCOP - Colorado Cancer Research Program, Incorporated
  - Denver, Colorado, United States, 80218-1191
    - St. Joseph Hospital
  - Denver, Colorado, United States, 80220
    - Rocky Mountain Cancer Centers - Rose
  - Englewood, Colorado, United States, 80110
    - Swedish Medical Center
  - Lone Tree, Colorado, United States, 80124
    - Sky Ridge Medical Center
  - Longmont, Colorado, United States, 80501
    - Longmont United Hospital
  - Pueblo, Colorado, United States, 81004
    - St. Mary-Corwin Regional Medical Center
  - Thornton, Colorado, United States, 80260
    - Rocky Mountain Cancer Centers
- Delaware
  - Newark, Delaware, United States, 19713
    - CCOP - Christiana Care Health Services
- District of Columbia
  - Washington, District of Columbia, United States, 20307-5000
    - Walter Reed Army Medical Center
  - Washington, District of Columbia, United States, 20422
    - Veterans Affairs Medical Center - Washington, DC
  - Washington, District of Columbia, United States, 20007
    - Lombardi Cancer Center at Georgetown University Medical Center
  - Washington, District of Columbia, United States, 20060
    - MBCCOP - Howard University Cancer Center
- Florida
  - Fort Lauderdale, Florida, United States, 33316
    - Broward General Medical Center
  - Hollywood, Florida, United States, 33021
    - Memorial Regional Hospital Comprehensive Cancer Center
  - Miami Beach, Florida, United States, 33140
    - CCOP - Mount Sinai Medical Center
  - Orlando, Florida, United States, 32804
    - Florida Hospital Cancer Institute
  - Tampa, Florida, United States, 33612-9497
    - H. Lee Moffitt Cancer Center and Research Institute
  - West Palm Beach, Florida, United States, 33401
    - Palm Beach Cancer Institute
- Georgia
  - Atlanta, Georgia, United States, 30322
    - Winship Cancer Institute of Emory University
  - Atlanta, Georgia, United States, 30342-1701
    - CCOP - Atlanta Regional
  - Decatur, Georgia, United States, 30033
    - Veterans Affairs Medical Center - Atlanta (Decatur)
- Hawaii
  - Honolulu, Hawaii, United States, 96813
    - MBCCOP - Hawaii
- Illinois
  - Chicago, Illinois, United States, 60612
    - Veterans Affairs Medical Center - Chicago (Westside Hospital)
  - Chicago, Illinois, United States, 60637-1470
    - University of Chicago Cancer Research Center
  - Chicago, Illinois, United States, 60640
    - Louis A. Weiss Memorial Hospital
  - Chicago, Illinois, United States, 60612
    - MBCCOP - University of Illinois at Chicago
  - Chicago, Illinois, United States, 60611
    - Robert H. Lurie Comprehensive Cancer Center at Northwestern University
  - Chicago, Illinois, United States, 60611-4494
    - Veterans Affairs Medical Center - Lakeside Chicago
  - Decatur, Illinois, United States, 62526
    - CCOP - Central Illinois
  - Evanston, Illinois, United States, 60201
    - CCOP - Evanston
  - Hines, Illinois, United States, 60141
    - Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
  - Maywood, Illinois, United States, 60153-5500
    - Cardinal Bernardin Cancer Center at Loyola University Medical Center
  - Peoria, Illinois, United States, 61602
    - CCOP - Illinois Oncology Research Association
  - River Forest, Illinois, United States, 60305
    - West Suburban Center for Cancer Care
  - Rockford, Illinois, United States, 61108
    - Saint Anthony Medical Center
  - Urbana, Illinois, United States, 61801
    - CCOP - Carle Cancer Center
- Indiana
  - Fort Wayne, Indiana, United States, 46885-5099
    - Fort Wayne Medical Oncology and Hematology, Incorporated
  - South Bend, Indiana, United States, 46601
    - CCOP - Northern Indiana CR Consortium
- Iowa
  - Bettendorf, Iowa, United States, 52722
    - Hematology Oncology Associates of the Quad Cities
  - Cedar Rapids, Iowa, United States, 52403-1206
    - CCOP - Cedar Rapids Oncology Project
  - Davenport, Iowa, United States, 52804
    - Genesis Medical Center
  - Des Moines, Iowa, United States, 50309-1016
    - CCOP - Iowa Oncology Research Association
  - Iowa City, Iowa, United States, 52242-1009
    - Holden Comprehensive Cancer Center at University of Iowa
- Kansas
  - Kansas City, Kansas, United States, 66160-7353
    - Kansas Cancer Institute at the University of Kansas Medical Center
  - Wichita, Kansas, United States, 67214-3882
    - CCOP - Wichita
  - Wichita, Kansas, United States, 67218
    - Veterans Affairs Medical Center - Wichita
- Kentucky
  - Lexington, Kentucky, United States, 40502-2236
    - Veterans Affairs Medical Center - Lexington
  - Lexington, Kentucky, United States, 40536-0084
    - Markey Cancer Center at University of Kentucky Chandler Medical Center
  - Louisville, Kentucky, United States, 40207
    - Baptist Hospital East - Louisville
- Louisiana
  - New Orleans, Louisiana, United States, 70112
    - Tulane University School of Medicine
  - New Orleans, Louisiana, United States, 70112
    - Veterans Affairs Medical Center - New Orleans
  - New Orleans, Louisiana, United States, 70121
    - CCOP - Ochsner
  - New Orleans, Louisiana, United States, 70112
    - MBCCOP - LSU Health Sciences Center
  - Shreveport, Louisiana, United States, 71130-3932
    - Louisiana State University Health Sciences Center - Shreveport
  - Shreveport, Louisiana, United States, 71130
    - Veterans Affairs Medical Center - Shreveport
- Maryland
  - Baltimore, Maryland, United States, 21201
    - Marlene and Stewart Greenebaum Cancer Center, University of Maryland
  - Baltimore, Maryland, United States, 21201
    - Veterans Affairs Medical Center - Baltimore
  - Baltimore, Maryland, United States, 21231
    - Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Massachusetts
  - Boston, Massachusetts, United States, 02215
    - Beth Israel Deaconess Medical Center
  - Boston, Massachusetts, United States, 02115
    - Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
  - Boston, Massachusetts, United States, 02118
    - Cancer Research Center at Boston Medical Center
  - Boston, Massachusetts, United States, 02111
    - TUFTS - New England Medical Center
  - Worcester, Massachusetts, United States, 01655
    - University of Massachusetts Memorial Medical Center - University Campus
- Michigan
  - Ann Arbor, Michigan, United States, 48105
    - Veterans Affairs Medical Center - Ann Arbor
  - Ann Arbor, Michigan, United States, 48106
    - CCOP - Michigan Cancer Research Consortium
  - Ann Arbor, Michigan, United States, 48109-0912
    - University of Michigan Comprehensive Cancer Center
  - Detroit, Michigan, United States, 48202
    - Josephine Ford Cancer Center at Henry Ford Hospital
  - Detroit, Michigan, United States, 48201-1379
    - Barbara Ann Karmanos Cancer Institute
  - Detroit, Michigan, United States, 48201-1932
    - Veterans Affairs Medical Center - Detroit
  - Grand Rapids, Michigan, United States, 49503
    - CCOP - Grand Rapids
  - Kalamazoo, Michigan, United States, 49007-3731
    - CCOP - Kalamazoo
  - Royal Oak, Michigan, United States, 48073-6769
    - CCOP - Beaumont
  - Saint Joseph, Michigan, United States, 49085
    - Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
  - Southfield, Michigan, United States, 48075
    - Providence Cancer Institute at Providence Hospital
- Minnesota
  - Minneapolis, Minnesota, United States, 55417
    - Veterans Affairs Medical Center - Minneapolis
  - Minneapolis, Minnesota, United States, 55455
    - University of Minnesota Cancer Center
  - Rochester, Minnesota, United States, 55905
    - Mayo Clinic Cancer Center
  - Saint Louis Park, Minnesota, United States, 55416
    - CCOP - Metro-Minnesota
- Mississippi
  - Biloxi, Mississippi, United States, 39531-2410
    - Veterans Affairs Medical Center - Biloxi
  - Jackson, Mississippi, United States, 39216-4505
    - University of Mississippi Medical Center
  - Jackson, Mississippi, United States, 39216
    - Veterans Affairs Medical Center - Jackson
- Missouri
  - Columbia, Missouri, United States, 65201
    - Veterans Affairs Medical Center - Columbia (Truman Memorial)
  - Columbia, Missouri, United States, 65203
    - Ellis Fischel Cancer Center at University of Missouri - Columbia
  - Kansas City, Missouri, United States, 64128
    - Veterans Affairs Medical Center - Kansas City
  - Kansas City, Missouri, United States, 64131
    - CCOP - Kansas City
  - Saint Louis, Missouri, United States, 63110
    - Barnes-Jewish Hospital
  - Saint Louis, Missouri, United States, 63131
    - Missouri Baptist Cancer Center
  - Saint Louis, Missouri, United States, 63141
    - CCOP - St. Louis-Cape Girardeau
  - Saint Louis, Missouri, United States, 63110
    - St. Louis University Hospital Cancer Center
  - Springfield, Missouri, United States, 65807
    - CCOP - Cancer Research for the Ozarks
- Montana
  - Billings, Montana, United States, 59101
    - CCOP - Montana Cancer Consortium
- Nebraska
  - Omaha, Nebraska, United States, 68198-7680
    - UNMC Eppley Cancer Center at the University of Nebraska Medical Center
- Nevada
  - Las Vegas, Nevada, United States, 89106
    - CCOP - Southern Nevada Cancer Research Foundation
  - Las Vegas, Nevada, United States, 89106
    - Veterans Affairs Medical Center - Las Vegas
- New Hampshire
  - Lebanon, New Hampshire, United States, 03756-0002
    - Norris Cotton Cancer Center at Dartmouth Medical School
- New Jersey
  - Camden, New Jersey, United States, 08103
    - Cooper University Hospital
  - East Orange, New Jersey, United States, 07019
    - Veterans Affairs Medical Center - East Orange
  - New Brunswick, New Jersey, United States, 08903
    - Cancer Institute of New Jersey
- New Mexico
  - Albuquerque, New Mexico, United States, 87108-5138
    - Veterans Affairs Medical Center - Albuquerque
  - Albuquerque, New Mexico, United States, 87131
    - MBCCOP - University of New Mexico HSC
- New York
  - Albany, New York, United States, 12208
    - Veterans Affairs Medical Center - Albany
  - Bronx, New York, United States, 10461
    - Albert Einstein Clinical Cancer Center
  - Buffalo, New York, United States, 14215
    - Veterans Affairs Medical Center - Buffalo
  - Elmhurst, New York, United States, 11373
    - Elmhurst Hospital Center
  - Jamaica, New York, United States, 11432
    - Queens Cancer Center of Queens Hospital
  - Manhasset, New York, United States, 11030
    - CCOP - North Shore University Hospital
  - Manhasset, New York, United States, 11030
    - North Shore University Hospital
  - New York, New York, United States, 10021
    - Memorial Sloan-Kettering Cancer Center
  - New York, New York, United States, 10029
    - Mount Sinai Medical Center, NY
  - New York, New York, United States, 10021
    - New York Weill Cornell Cancer Center at Cornell University
  - New York, New York, United States, 10032
    - Herbert Irving Comprehensive Cancer Center at Columbia University
  - Rochester, New York, United States, 14642
    - James P. Wilmot Cancer Center at University of Rochester Medical Center
  - Syracuse, New York, United States, 13210
    - Veterans Affairs Medical Center - Syracuse
  - Syracuse, New York, United States, 13217
    - CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
  - Syracuse, New York, United States, 13210
    - University Hospital at State University of New York - Upstate Medical University
- North Carolina
  - Asheville, North Carolina, United States, 28805
    - Veterans Affairs Medical Center - Asheville
  - Chapel Hill, North Carolina, United States, 27599-7295
    - Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
  - Concord, North Carolina, United States, 28025
    - NorthEast Oncology Associates
  - Durham, North Carolina, United States, 27705
    - Veterans Affairs Medical Center - Durham
  - Durham, North Carolina, United States, 27710
    - Duke Comprehensive Cancer Center
  - Fayetteville, North Carolina, United States, 28302-2000
    - Cape Fear Valley Health System
  - Kinston, North Carolina, United States, 28503-1678
    - Lenoir Memorial Hospital Cancer Center
  - Pinehurst, North Carolina, United States, 28374
    - FirstHealth Moore Regional Hospital
  - Wilmington, North Carolina, United States, 28402-9025
    - New Hanover Regional Medical Center
  - Winston-Salem, North Carolina, United States, 27104-4241
    - CCOP - Southeast Cancer Control Consortium
  - Winston-Salem, North Carolina, United States, 27157-1082
    - Comprehensive Cancer Center at Wake Forest University
- North Dakota
  - Fargo, North Dakota, United States, 58102
    - Veterans Affairs Medical Center - Fargo
  - Fargo, North Dakota, United States, 58122
    - CCOP - Merit Care Hospital
- Ohio
  - Cincinnati, Ohio, United States, 45220-2288
    - Veterans Affairs Medical Center - Cincinnati
  - Cincinnati, Ohio, United States, 45267-0501
    - Charles M. Barrett Cancer Center at University Hospital
  - Cleveland, Ohio, United States, 44109
    - MetroHealth Medical Center
  - Cleveland, Ohio, United States, 44195-9001
    - Cleveland Clinic Taussig Cancer Center
  - Columbus, Ohio, United States, 43210-1240
    - Arthur G. James Cancer Hospital - Ohio State University
  - Columbus, Ohio, United States, 43206
    - CCOP - Columbus
  - Dayton, Ohio, United States, 45429
    - CCOP - Dayton
  - Dayton, Ohio, United States, 45428-1002
    - Veterans Affairs Medical Center - Dayton
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73104
    - Veterans Affairs Medical Center - Oklahoma City
  - Oklahoma City, Oklahoma, United States, 73104
    - Oklahoma University Medical Center at University of Oklahoma Health Sciences Center
- Oregon
  - Portland, Oregon, United States, 97207
    - Veterans Affairs Medical Center - Portland
  - Portland, Oregon, United States, 97225
    - CCOP - Columbia River Oncology Program
  - Portland, Oregon, United States, 97201-3098
    - Cancer Institute at Oregon Health and Science University
- Pennsylvania
  - Danville, Pennsylvania, United States, 17822-2001
    - CCOP - Geisinger Clinic and Medical Center
  - Hershey, Pennsylvania, United States, 17033-0850
    - Penn State Cancer Institute at Milton S. Hershey Medical Center
  - Pittsburgh, Pennsylvania, United States, 15224
    - Western Pennsylvania Hospital
  - Pittsburgh, Pennsylvania, United States, 15236
    - Hillman Cancer Center at University of Pittsburgh Cancer Institute
  - Wynnewood, Pennsylvania, United States, 19096
    - CCOP - MainLine Health
- Rhode Island
  - Providence, Rhode Island, United States, 02906
    - Lifespan: The Miriam Hospital
- South Carolina
  - Charleston, South Carolina, United States, 29425
    - Hollings Cancer Center at Medical University of South Carolina
  - Charleston, South Carolina, United States, 29401-5799
    - Veterans Affairs Medical Center - Charleston
  - Greenville, South Carolina, United States, 29615
    - CCOP - Greenville
  - Spartanburg, South Carolina, United States, 29303
    - CCOP - Upstate Carolina
- South Dakota
  - Sioux Falls, South Dakota, United States, 57104
    - CCOP - Sioux Community Cancer Consortium
- Tennessee
  - Memphis, Tennessee, United States, 38103
    - University of Tennessee Cancer Institute
  - Memphis, Tennessee, United States, 38104
    - Danville Radiation Therapy Center
- Texas
  - Amarillo, Texas, United States, 79106
    - Harrington Cancer Center
  - Amarillo, Texas, United States, 79106
    - Veterans Affairs Medical Center - Amarillo
  - Dallas, Texas, United States, 75216
    - Veterans Affairs Medical Center - Dallas
  - Dallas, Texas, United States, 75230
    - Medical City Dallas Hospital
  - Dallas, Texas, United States, 75390
    - Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
  - Fort Sam Houston, Texas, United States, 78234-6200
    - Brooke Army Medical Center
  - Galveston, Texas, United States, 77555-0565
    - University of Texas Medical Branch
  - Houston, Texas, United States, 77030
    - Veterans Affairs Medical Center - Houston
  - Houston, Texas, United States, 77030-4095
    - University of Texas - MD Anderson Cancer Center
  - San Antonio, Texas, United States, 78229-3900
    - University of Texas Health Science Center at San Antonio
  - San Antonio, Texas, United States, 78229
    - Veterans Affairs Medical Center - San Antonio (Murphy)
  - Temple, Texas, United States, 76504
    - Veterans Affairs Medical Center - Temple
  - Temple, Texas, United States, 76508
    - CCOP - Scott and White Hospital
- Utah
  - Salt Lake City, Utah, United States, 84148
    - Veterans Affairs Medical Center - Salt Lake City
  - Salt Lake City, Utah, United States, 84112-5550
    - Huntsman Cancer Institute
- Vermont
  - Bennington, Vermont, United States, 05201
    - Green Mountain Oncology Group
  - Burlington, Vermont, United States, 05401-3498
    - Vermont Cancer Center at University of Vermont
  - White River Junction, Vermont, United States, 05009
    - Veterans Affairs Medical Center - White River Junction
- Virginia
  - Charlottesville, Virginia, United States, 22902
    - Martha Jefferson Hospital
  - Norfolk, Virginia, United States, 23502
    - Virginia Oncology Associates - Norfolk
  - Richmond, Virginia, United States, 23298-0037
    - MBCCOP - Massey Cancer Center
  - Roanoke, Virginia, United States, 24014
    - Oncology and Hematology Associates of Southwest Virginia, Inc.
- Washington
  - Seattle, Washington, United States, 98101
    - CCOP - Virginia Mason Research Center
  - Seattle, Washington, United States, 98108
    - Veterans Affairs Medical Center - Seattle
  - Seattle, Washington, United States, 98109
    - Puget Sound Oncology Consortium
  - Tacoma, Washington, United States, 98431-5000
    - Madigan Army Medical Center
  - Tacoma, Washington, United States, 98405-0986
    - CCOP - Northwest
- West Virginia
  - Huntington, West Virginia, United States, 25701
    - St. Mary's Medical Center
- Wisconsin
  - Green Bay, Wisconsin, United States, 54307-3453
    - CCOP - St. Vincent Hospital Cancer Center, Green Bay
  - Madison, Wisconsin, United States, 53792-0001
    - University of Wisconsin Comprehensive Cancer Center
  - Marshfield, Wisconsin, United States, 54449
    - CCOP - Marshfield Clinic Research Foundation
  - Rhinelander, Wisconsin, United States, 54501
    - Ministry Medical Group - Northern Region

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

DISEASE CHARACTERISTICS:

Diagnosis of chronic lymphocytic leukemia (CLL) of any stage as defined by the following:
- Peripheral blood absolute lymphocyte count greater than 5,000/mm^3 within 14 days prior to study
- Lymphocytes must be small to moderate size with no more than 55% prolymphocytes, atypical lymphocytes, or lymphoblasts morphologically
- Phenotypically characterized as B-CLL
Must have one of the following characteristics indicating need for chemotherapy:
- Progressive marrow failure (hemoglobin less than 10 g/dL and/or platelet count less than 100,000/mm^3)
- Progressive lymphocytosis with an increase of more than 50% over a 2 month period or anticipated doubling time of less than 6 months
- Massive (i.e., greater than 6 cm below left costal margin) or progressive splenomegaly
- Massive nodes or clusters (i.e., greater than 10 cm in longest diameter) or progressive adenopathy
- At least 10% weight loss within 6 months of study
- Extreme fatigue
- Fevers greater than 100.5 degrees F for 2 weeks without evidence of infection
- Night sweats without evidence of infection
No autoimmune anemia or autoimmune thrombocytopenia

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

ECOG 0-2

Life expectancy:

Not specified

Hematopoietic:

See Disease Characteristics

Hepatic:

Bilirubin no greater than 2 mg/dL unless secondary to tumor

Renal:

Creatinine no greater than 2.0 mg/dL
Creatinine clearance at least 40 mL/min if creatinine is greater than 1.5 mg/dL

Other:

No other prior or concurrent malignancy within the past 2 years except basal cell carcinoma of the skin or carcinoma in situ of the cervix
No active infection requiring oral or intravenous antibiotics
Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

No prior cytotoxic chemotherapy

Endocrine therapy:

No prior steroid treatment for CLL

Radiotherapy:

Not specified

Surgery:

Not specified

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eastern Cooperative Oncology Group

Collaborators

National Cancer Institute (NCI)

Cancer and Leukemia Group B

SWOG Cancer Research Network

Investigators

Study Chair: Mohamad A. Hussein, MD, The Cleveland Clinic
Study Chair: Ian W. Flinn, MD, PhD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Chair: Michael R. Grever, MD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Dewald GW, Paietta E, Goloubeva O, et al.: Correlation of interphase fluorescence in situ hybridization (FISH) anomalies with cell morphology and immunophenotyping in chronic lymphocytic leukemia (B-CLL). [Abstract] Blood 100 (11 pt 1): A-2334, 2002.
Flinn IW, Neuberg DS, Grever MR, Dewald GW, Bennett JM, Paietta EM, Hussein MA, Appelbaum FR, Larson RA, Moore DF Jr, Tallman MS. Phase III trial of fludarabine plus cyclophosphamide compared with fludarabine for patients with previously untreated chronic lymphocytic leukemia: US Intergroup Trial E2997. J Clin Oncol. 2007 Mar 1;25(7):793-8. doi: 10.1200/JCO.2006.08.0762. Epub 2007 Feb 5.
Grever MR, Lucas DM, Dewald GW, Neuberg DS, Reed JC, Kitada S, Flinn IW, Tallman MS, Appelbaum FR, Larson RA, Paietta E, Jelinek DF, Gribben JG, Byrd JC. Comprehensive assessment of genetic and molecular features predicting outcome in patients with chronic lymphocytic leukemia: results from the US Intergroup Phase III Trial E2997. J Clin Oncol. 2007 Mar 1;25(7):799-804. doi: 10.1200/JCO.2006.08.3089. Epub 2007 Feb 5.
Byrd JC, Gribben JG, Peterson BL, Grever MR, Lozanski G, Lucas DM, Lampson B, Larson RA, Caligiuri MA, Heerema NA. Select high-risk genetic features predict earlier progression following chemoimmunotherapy with fludarabine and rituximab in chronic lymphocytic leukemia: justification for risk-adapted therapy. J Clin Oncol. 2006 Jan 20;24(3):437-43. doi: 10.1200/JCO.2005.03.1021. Epub 2005 Dec 12.
Flinn IW, Kumm E, Grever MR, et al.: Fludarabine and cyclophosphamide produces a higher complete response rate and more durable remissions than fludarabine in patients with previously untreated CLL: Intergroup trial E2997. [Abstract] Blood 104 (11): A-475, 2004.
Grever MR, Lucas DM, Dewald GW, et al.: Outcome of treatment with fludarabine versus fludarabine and cyclophosphamide in chronic lymphocytic leukemia (CLL) is adversely impacted by high risk genetic features: results from ECOG 2997. [Abstract] Blood 104 (11 Pt 1): A-3487, 2004.
Lucas DM, Ruppert AS, Lozanski G, Dewald GW, Lozanski A, Claus R, Plass C, Flinn IW, Neuberg DS, Paietta EM, Bennett JM, Jelinek DF, Gribben JG, Hussein MA, Appelbaum FR, Larson RA, Moore DF Jr, Tallman MS, Byrd JC, Grever MR. Cytogenetic prioritization with inclusion of molecular markers predicts outcome in previously untreated patients with chronic lymphocytic leukemia treated with fludarabine or fludarabine plus cyclophosphamide: a long-term follow-up study of the US intergroup phase III trial E2997. Leuk Lymphoma. 2015;56(11):3031-7. doi: 10.3109/10428194.2015.1023800. Epub 2015 Mar 30.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2000

Primary Completion (Actual)

November 1, 2005

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimated)

January 27, 2003

Study Record Updates

Last Update Posted (Estimated)

June 16, 2023

Last Update Submitted That Met QC Criteria

June 14, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

CDR0000066890
E2997
CALGB-10103
SWOG-E2997

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Leukemia

Stanford University

Terminated

Allogeneic Transplantation for Patients With Acute Leukemia or Chronic Myelogenous Leukemia (CML)

Leukemia | Leukemia, Lymphocytic, Acute | Leukemia Acute Promyelocytic Leukemia (APL) | Leukemia Acute Lymphoid Leukemia (ALL) | Leukemia Chronic Myelogenous Leukemia (CML) | Leukemia Acute Myeloid Leukemia (AML) | Leukemia Chronic Lymphocytic Leukemia (CLL)

United States
Massachusetts General Hospital
Celgene Corporation

Terminated

Lenalidomide in Combination With Microtransplantation as Post-remission Therapy in AML

Acute Myelogenous Leukemia | Acute Myeloid Leukemia (AML) | Acute Myelocytic Leukemia | Acute Granulocytic Leukemia | Acute Non-Lymphocytic Leukemia

United States
Institute of Hematology & Blood Diseases Hospital
Bejing Institute for Stem Cell and Regenerative Medicine; Institute for Stem...

Recruiting

Safety and Preliminary Efficacy of JK500 Cell Injection in Relapsed/Refractory Pediatric Acute Myeloid Leukemia

Refractory Leukemia | Relapsed Leukemia | Acute Myeloid Leukemia, Childhood

China
Children's Oncology Group
National Cancer Institute (NCI)

Completed

Studying Biomarkers in Samples From Younger Patients With Acute Myeloid Leukemia

Childhood Acute Monoblastic Leukemia (M5a) | Childhood Acute Monocytic Leukemia (M5b) | Childhood Acute Myeloblastic Leukemia Without Maturation (M1) | Childhood Acute Myelomonocytic Leukemia (M4) | Childhood Acute Myeloid Leukemia/Other Myeloid Malignancies

United States
Hybrigenics Corporation

Unknown

Efficacy Study of Inecalcitol With Decitabine in Acute Myeloid Leukemia Patients Unfit for Standard Chemotherapy

Acute Myelogenous Leukemia

United States, France
Betta Pharmaceuticals Co., Ltd.

Not yet recruiting

A Study of MRX2843 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia

Acute Myeloid Leukemia Leukemia

China
Beijing Boren Hospital

Recruiting

Phase I/II Study of Enhanced CD33 CAR T Cells in Subjects With Relapsed or Refractory Acute Myeloid Leukemia

Acute Myeloid Leukemia | Refractory Acute Myeloid Leukemia | Relapse Leukemia

China
Center for International Blood and Marrow Transplant...
National Marrow Donor Program; St. Baldrick's Foundation

Active, not recruiting

Study of Anti-CD33 Chimeric Antigen Receptor-Expressing T Cells (CD33CART) in Children and Young Adults With Relapsed/Refractory Acute Myeloid Leukemia

Acute Myelogenous Leukemia

United States
Massachusetts General Hospital

Completed

Alisertib for Acute Myeloid Leukemia

Acute Myelogenous Leukemia

United States
Kinex Pharmaceuticals Inc.

Completed

Evaluation of KX2-391 in Elderly Subjects With Acute Myeloid Leukemia (AML)

Acute Myelogenous Leukemia

United States

Clinical Trials on cyclophosphamide

Children's Hospital Los Angeles
Lucile Packard Children's Hospital

Terminated

Related Hematopoietic Stem Cell Transplantation (HSCT) for Genetic Diseases of Blood Cells

Metabolic Diseases | Stem Cell Transplantation | Chronic Granulomatous Disease | Bone Marrow Transplantation | Thalassemia | Wiskott-Aldrich Syndrome | Genetic Diseases | Peripheral Blood Stem Cell Transplantation | Pediatrics | Diamond-Blackfan Anemia | Allogeneic Transplantation | Combined Immune Deficiency | X-linked Lymphoproliferative Disease
Medical College of Wisconsin
National Cancer Institute (NCI); National Heart, Lung, and Blood Institute... and other collaborators

Completed

Fludarabine-based Conditioning for Severe Aplastic Anemia (BMT CTN 0301)

Anemia, Aplastic

United States
Columbia University

Unknown

Risk-Adapted Allogeneic Stem Cell Transplantation For Mixed Donor Chimerism In Patients With Non-Malignant Diseases

Severe Combined Immunodeficiency | Fanconi Anemia | Bone Marrow Failure | Osteopetrosis

United States
National Cancer Institute, Naples
Immatics Biotechnologies GmbH; CureVac; European Commission -FP7-Health-2013-Innovation-1

Completed

IMA970A Plus CV8102 in Very Early, Early and Intermediate Stage Hepatocellular Carcinoma Patients

Hepatocellular Carcinoma

Belgium, Germany, Italy, Spain, United Kingdom
Centre Oscar Lambret

Completed

Imatinib Mesylate And Cyclophosphamide In Metronomic Administration: Dose Escalation Study Of Imatinib Mesylate (PALANGI3)

Cancer

France
Mahidol University

Terminated

Low-dose VS High-dose IV Cyclophosphamide for Proliferative LN in Children (Low/highIVCY)

Renal Insufficiency | Infection

Thailand
Eisai Inc.

Completed

A Study of ZYC300 Administered With Cyclophosphamide Pre-Dosing

Breast Cancer | Ovarian Cancer | Prostate Cancer | Colon Cancer | Renal Cancer

United States
Baylor Research Institute

Completed

Combined Modality Treatment for Patients With Stage IV Melanoma

Malignant Melanoma Stage IV

United States
University of Turin, Italy

Unknown

Letrozole Plus Oral Cyclophosphamide Plus/Minus Sorafenib as Primary Systemic Treatment in Breast Cancer Patients

Breast Cancer

Italy
Merck KGaA, Darmstadt, Germany

Completed

Study of Tecemotide (L-BLP25) in Subjects With Slowly Progressive Multiple Myeloma With no Symptoms and Who Have Had no Chemotherapy

Multiple Myeloma

Germany

Fludarabine With or Without Cyclophosphamide in Treating Patients With Chronic Lymphocytic Leukemia

Phase III Randomized Trial of Fludarabine and Cyclophosphamide Versus Fludarabine for Previously Untreated Chronic Lymphocytic Leukemia

Study Overview

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Study Record Updates

Last Update Posted (Estimated)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Leukemia

Clinical Trials on cyclophosphamide

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