NCT00003764

Brief Summary

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.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P50-P75 for phase_3 leukemia

Geographic Reach
4 countries

218 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4 months until next milestone

Study Start

First participant enrolled

March 9, 2000

Completed
2.9 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

5.7 years

First QC Date

November 1, 1999

Last Update Submit

June 14, 2023

Conditions

Keywords

stage 0 chronic lymphocytic leukemiastage I chronic lymphocytic leukemiastage II chronic lymphocytic leukemiastage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemiaB-cell chronic lymphocytic leukemia

Interventions

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (218)

Northeast Alabama Regional Medical Center

Anniston, Alabama, 36207, United States

Location

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35294-3300, United States

Location

MBCCOP - Gulf Coast

Mobile, Alabama, 36688, United States

Location

CCOP - Western Regional, Arizona

Phoenix, Arizona, 85006-2726, United States

Location

Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)

Phoenix, Arizona, 85012, United States

Location

Veterans Affairs Medical Center - Tucson

Tucson, Arizona, 85723, United States

Location

Arizona Cancer Center at University of Arizona Health Sciences Center

Tucson, Arizona, 85724, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Veterans Affairs Medical Center - Little Rock (McClellan)

Little Rock, Arkansas, 72205, United States

Location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-0269, United States

Location

Rebecca and John Moores UCSD Cancer Center

La Jolla, California, 92093-0658, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90033, United States

Location

Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

Veterans Affairs Outpatient Clinic - Martinez

Martinez, California, 94553, United States

Location

CCOP - Bay Area Tumor Institute

Oakland, California, 94609-3305, United States

Location

Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center

Orange, California, 92868, United States

Location

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

Veterans Affairs Medical Center - San Diego

San Diego, California, 92161, United States

Location

Veterans Affairs Medical Center - San Francisco

San Francisco, California, 94121, United States

Location

CCOP - Santa Rosa Memorial Hospital

Santa Rosa, California, 95403, United States

Location

David Grant Medical Center

Travis Air Force Base, California, 94535, United States

Location

University of Colorado Cancer Center at University of Colorado Health Sciences Center

Aurora, Colorado, 80010, United States

Location

Medical Center of Aurora - South Campus

Aurora, Colorado, 80012-0000, United States

Location

Boulder Community Hospital

Boulder, Colorado, 80301-9019, United States

Location

Penrose Cancer Center

Colorado Springs, Colorado, 80933, United States

Location

Porter Adventist Hospital

Denver, Colorado, 80210, United States

Location

St. Joseph Hospital

Denver, Colorado, 80218-1191, United States

Location

Presbyterian-St Luke's Medical Center

Denver, Colorado, 80218, United States

Location

Rocky Mountain Cancer Centers - Rose

Denver, Colorado, 80220, United States

Location

CCOP - Colorado Cancer Research Program, Incorporated

Denver, Colorado, 80224, United States

Location

Swedish Medical Center

Englewood, Colorado, 80110, United States

Location

Sky Ridge Medical Center

Lone Tree, Colorado, 80124, United States

Location

Longmont United Hospital

Longmont, Colorado, 80501, United States

Location

St. Mary-Corwin Regional Medical Center

Pueblo, Colorado, 81004, United States

Location

Rocky Mountain Cancer Centers

Thornton, Colorado, 80260, United States

Location

CCOP - Christiana Care Health Services

Newark, Delaware, 19713, United States

Location

Lombardi Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

MBCCOP - Howard University Cancer Center

Washington D.C., District of Columbia, 20060, United States

Location

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307-5000, United States

Location

Veterans Affairs Medical Center - Washington, DC

Washington D.C., District of Columbia, 20422, United States

Location

Broward General Medical Center

Fort Lauderdale, Florida, 33316, United States

Location

Memorial Regional Hospital Comprehensive Cancer Center

Hollywood, Florida, 33021, United States

Location

CCOP - Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

Florida Hospital Cancer Institute

Orlando, Florida, 32804, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612-9497, United States

Location

Palm Beach Cancer Institute

West Palm Beach, Florida, 33401, United States

Location

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

Location

CCOP - Atlanta Regional

Atlanta, Georgia, 30342-1701, United States

Location

Veterans Affairs Medical Center - Atlanta (Decatur)

Decatur, Georgia, 30033, United States

Location

MBCCOP - Hawaii

Honolulu, Hawaii, 96813, United States

Location

Veterans Affairs Medical Center - Lakeside Chicago

Chicago, Illinois, 60611-4494, United States

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611, United States

Location

MBCCOP - University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Veterans Affairs Medical Center - Chicago (Westside Hospital)

Chicago, Illinois, 60612, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Louis A. Weiss Memorial Hospital

Chicago, Illinois, 60640, United States

Location

CCOP - Central Illinois

Decatur, Illinois, 62526, United States

Location

CCOP - Evanston

Evanston, Illinois, 60201, United States

Location

Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)

Hines, Illinois, 60141, United States

Location

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Maywood, Illinois, 60153-5500, United States

Location

CCOP - Illinois Oncology Research Association

Peoria, Illinois, 61602, United States

Location

West Suburban Center for Cancer Care

River Forest, Illinois, 60305, United States

Location

Saint Anthony Medical Center

Rockford, Illinois, 61108, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Fort Wayne Medical Oncology and Hematology, Incorporated

Fort Wayne, Indiana, 46885-5099, United States

Location

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, 46601, United States

Location

Hematology Oncology Associates of the Quad Cities

Bettendorf, Iowa, 52722, United States

Location

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, 52403-1206, United States

Location

Genesis Medical Center

Davenport, Iowa, 52804, United States

Location

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 50309-1016, United States

Location

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, 52242-1009, United States

Location

Kansas Cancer Institute at the University of Kansas Medical Center

Kansas City, Kansas, 66160-7353, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

Veterans Affairs Medical Center - Wichita

Wichita, Kansas, 67218, United States

Location

Veterans Affairs Medical Center - Lexington

Lexington, Kentucky, 40502-2236, United States

Location

Markey Cancer Center at University of Kentucky Chandler Medical Center

Lexington, Kentucky, 40536-0084, United States

Location

Baptist Hospital East - Louisville

Louisville, Kentucky, 40207, United States

Location

MBCCOP - LSU Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Tulane University School of Medicine

New Orleans, Louisiana, 70112, United States

Location

Veterans Affairs Medical Center - New Orleans

New Orleans, Louisiana, 70112, United States

Location

CCOP - Ochsner

New Orleans, Louisiana, 70121, United States

Location

Louisiana State University Health Sciences Center - Shreveport

Shreveport, Louisiana, 71130-3932, United States

Location

Veterans Affairs Medical Center - Shreveport

Shreveport, Louisiana, 71130, United States

Location

Marlene and Stewart Greenebaum Cancer Center, University of Maryland

Baltimore, Maryland, 21201, United States

Location

Veterans Affairs Medical Center - Baltimore

Baltimore, Maryland, 21201, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231, United States

Location

Tufts - New England Medical Center

Boston, Massachusetts, 02111, United States

Location

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Cancer Research Center at Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Massachusetts Memorial Medical Center - University Campus

Worcester, Massachusetts, 01655, United States

Location

Veterans Affairs Medical Center - Ann Arbor

Ann Arbor, Michigan, 48105, United States

Location

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, 48106, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0912, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Veterans Affairs Medical Center - Detroit

Detroit, Michigan, 48201-1932, United States

Location

Josephine Ford Cancer Center at Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

CCOP - Grand Rapids

Grand Rapids, Michigan, 49503, United States

Location

CCOP - Kalamazoo

Kalamazoo, Michigan, 49007-3731, United States

Location

CCOP - Beaumont

Royal Oak, Michigan, 48073-6769, United States

Location

Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph

Saint Joseph, Michigan, 49085, United States

Location

Providence Cancer Institute at Providence Hospital

Southfield, Michigan, 48075, United States

Location

Veterans Affairs Medical Center - Minneapolis

Minneapolis, Minnesota, 55417, United States

Location

University of Minnesota Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

Veterans Affairs Medical Center - Biloxi

Biloxi, Mississippi, 39531-2410, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216-4505, United States

Location

Veterans Affairs Medical Center - Jackson

Jackson, Mississippi, 39216, United States

Location

Veterans Affairs Medical Center - Columbia (Truman Memorial)

Columbia, Missouri, 65201, United States

Location

Ellis Fischel Cancer Center at University of Missouri - Columbia

Columbia, Missouri, 65203, United States

Location

Veterans Affairs Medical Center - Kansas City

Kansas City, Missouri, 64128, United States

Location

CCOP - Kansas City

Kansas City, Missouri, 64131, United States

Location

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, 65807, United States

Location

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

St. Louis University Hospital Cancer Center

St Louis, Missouri, 63110, United States

Location

Missouri Baptist Cancer Center

St Louis, Missouri, 63131, United States

Location

CCOP - St. Louis-Cape Girardeau

St Louis, Missouri, 63141, United States

Location

CCOP - Montana Cancer Consortium

Billings, Montana, 59101, United States

Location

UNMC Eppley Cancer Center at the University of Nebraska Medical Center

Omaha, Nebraska, 68198-7680, United States

Location

CCOP - Southern Nevada Cancer Research Foundation

Las Vegas, Nevada, 89106, United States

Location

Veterans Affairs Medical Center - Las Vegas

Las Vegas, Nevada, 89106, United States

Location

Norris Cotton Cancer Center at Dartmouth Medical School

Lebanon, New Hampshire, 03756-0002, United States

Location

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

Veterans Affairs Medical Center - East Orange

East Orange, New Jersey, 07019, United States

Location

Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

Veterans Affairs Medical Center - Albuquerque

Albuquerque, New Mexico, 87108-5138, United States

Location

MBCCOP - University of New Mexico HSC

Albuquerque, New Mexico, 87131, United States

Location

Veterans Affairs Medical Center - Albany

Albany, New York, 12208, United States

Location

Veterans Affairs Medical Center - Buffalo

Buffalo, New York, 14215, United States

Location

Elmhurst Hospital Center

Elmhurst, New York, 11373, United States

Location

Queens Cancer Center of Queens Hospital

Jamaica, New York, 11432, United States

Location

CCOP - North Shore University Hospital

Manhasset, New York, 11030, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

New York Weill Cornell Cancer Center at Cornell University

New York, New York, 10021, United States

Location

Mount Sinai Medical Center, NY

New York, New York, 10029, United States

Location

Herbert Irving Comprehensive Cancer Center at Columbia University

New York, New York, 10032, United States

Location

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

University Hospital at State University of New York - Upstate Medical University

Syracuse, New York, 13210, United States

Location

Veterans Affairs Medical Center - Syracuse

Syracuse, New York, 13210, United States

Location

CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.

Syracuse, New York, 13217, United States

Location

Albert Einstein Clinical Cancer Center

The Bronx, New York, 10461, United States

Location

Veterans Affairs Medical Center - Asheville

Asheville, North Carolina, 28805, United States

Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7295, United States

Location

NorthEast Oncology Associates

Concord, North Carolina, 28025, United States

Location

Veterans Affairs Medical Center - Durham

Durham, North Carolina, 27705, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Cape Fear Valley Health System

Fayetteville, North Carolina, 28302-2000, United States

Location

Lenoir Memorial Hospital Cancer Center

Kinston, North Carolina, 28503-1678, United States

Location

FirstHealth Moore Regional Hospital

Pinehurst, North Carolina, 28374, United States

Location

New Hanover Regional Medical Center

Wilmington, North Carolina, 28402-9025, United States

Location

CCOP - Southeast Cancer Control Consortium

Winston-Salem, North Carolina, 27104-4241, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1082, United States

Location

Veterans Affairs Medical Center - Fargo

Fargo, North Dakota, 58102, United States

Location

CCOP - Merit Care Hospital

Fargo, North Dakota, 58122, United States

Location

Veterans Affairs Medical Center - Cincinnati

Cincinnati, Ohio, 45220-2288, United States

Location

Charles M. Barrett Cancer Center at University Hospital

Cincinnati, Ohio, 45267-0501, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195-9001, United States

Location

CCOP - Columbus

Columbus, Ohio, 43206, United States

Location

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, 43210-1240, United States

Location

Veterans Affairs Medical Center - Dayton

Dayton, Ohio, 45428-1002, United States

Location

CCOP - Dayton

Dayton, Ohio, 45429, United States

Location

Oklahoma University Medical Center at University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Veterans Affairs Medical Center - Oklahoma City

Oklahoma City, Oklahoma, 73104, United States

Location

Cancer Institute at Oregon Health and Science University

Portland, Oregon, 97201-3098, United States

Location

Veterans Affairs Medical Center - Portland

Portland, Oregon, 97207, United States

Location

CCOP - Columbia River Oncology Program

Portland, Oregon, 97225, United States

Location

CCOP - Geisinger Clinic and Medical Center

Danville, Pennsylvania, 17822-2001, United States

Location

Penn State Cancer Institute at Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location

Hillman Cancer Center at University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15236, United States

Location

CCOP - MainLine Health

Wynnewood, Pennsylvania, 19096, United States

Location

Lifespan: The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Veterans Affairs Medical Center - Charleston

Charleston, South Carolina, 29401-5799, United States

Location

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

CCOP - Greenville

Greenville, South Carolina, 29615, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

CCOP - Sioux Community Cancer Consortium

Sioux Falls, South Dakota, 57104, United States

Location

University of Tennessee Cancer Institute

Memphis, Tennessee, 38103, United States

Location

Danville Radiation Therapy Center

Memphis, Tennessee, 38104, United States

Location

Harrington Cancer Center

Amarillo, Texas, 79106, United States

Location

Veterans Affairs Medical Center - Amarillo

Amarillo, Texas, 79106, United States

Location

Veterans Affairs Medical Center - Dallas

Dallas, Texas, 75216, United States

Location

Medical City Dallas Hospital

Dallas, Texas, 75230, United States

Location

Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, 75390, United States

Location

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234-6200, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555-0565, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4095, United States

Location

Veterans Affairs Medical Center - Houston

Houston, Texas, 77030, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229-3900, United States

Location

Veterans Affairs Medical Center - San Antonio (Murphy)

San Antonio, Texas, 78229, United States

Location

Veterans Affairs Medical Center - Temple

Temple, Texas, 76504, United States

Location

CCOP - Scott and White Hospital

Temple, Texas, 76508, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112-5550, United States

Location

Veterans Affairs Medical Center - Salt Lake City

Salt Lake City, Utah, 84148, United States

Location

Green Mountain Oncology Group

Bennington, Vermont, 05201, United States

Location

Vermont Cancer Center at University of Vermont

Burlington, Vermont, 05401-3498, United States

Location

Veterans Affairs Medical Center - White River Junction

White River Junction, Vermont, 05009, United States

Location

Martha Jefferson Hospital

Charlottesville, Virginia, 22902, United States

Location

Virginia Oncology Associates - Norfolk

Norfolk, Virginia, 23502, United States

Location

MBCCOP - Massey Cancer Center

Richmond, Virginia, 23298-0037, United States

Location

Oncology and Hematology Associates of Southwest Virginia, Inc.

Roanoke, Virginia, 24014, United States

Location

CCOP - Virginia Mason Research Center

Seattle, Washington, 98101, United States

Location

Veterans Affairs Medical Center - Seattle

Seattle, Washington, 98108, United States

Location

Puget Sound Oncology Consortium

Seattle, Washington, 98109, United States

Location

CCOP - Northwest

Tacoma, Washington, 98405-0986, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98431-5000, United States

Location

St. Mary's Medical Center

Huntington, West Virginia, 25701, United States

Location

CCOP - St. Vincent Hospital Cancer Center, Green Bay

Green Bay, Wisconsin, 54307-3453, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792-0001, United States

Location

CCOP - Marshfield Clinic Research Foundation

Marshfield, Wisconsin, 54449, United States

Location

Ministry Medical Group - Northern Region

Rhinelander, Wisconsin, 54501, United States

Location

McGill University

Montreal, Quebec, H2W 1S6, Canada

Location

University of Puerto Rico School of Medicine Medical Sciences Campus

San Juan, 00936-5067, Puerto Rico

Location

Pretoria Academic Hospital

Pretoria, 0001, South Africa

Location

Related Publications (7)

  • 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.

    BACKGROUND
  • 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.

    RESULT
  • 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.

    RESULT
  • 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.

MeSH Terms

Conditions

LeukemiaLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

Cyclophosphamidefludarabine phosphate

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, B-CellLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Study Officials

  • 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

    STUDY CHAIR
  • Mohamad A. Hussein, MD

    The Cleveland Clinic

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NETWORK

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

March 9, 2000

Primary Completion

November 1, 2005

Last Updated

June 18, 2023

Record last verified: 2023-06

Locations