Fludarabine and Rituximab With or Without Lenalidomide or Cyclophosphamide in Treating Patients With Symptomatic Chronic Lymphocytic Leukemia
A Genetic Risk-Stratified, Randomized Phase II Study of Four Fludarabine/Antibody Combinations for Patients With Symptomatic, Previously Untreated Chronic Lymphocytic Leukemia
12 other identifiers
interventional
418
2 countries
364
Brief Summary
This randomized phase II trial studies how well fludarabine (fludarabine phosphate) and rituximab with or without lenalidomide or cyclophosphamide work in treating patients with symptomatic chronic lymphocytic leukemia. Drugs used in chemotherapy, such as fludarabine phosphate and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as rituximab, may block cancer growth in different ways by targeting certain cells. Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. Giving fludarabine phosphate and rituximab together with lenalidomide or cyclophosphamide may be an effective treatment for chronic lymphocytic leukemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2008
Longer than P75 for phase_2
364 active sites
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
Study Start
First participant enrolled
January 15, 2008
CompletedFirst Submitted
Initial submission to the registry
January 23, 2008
CompletedFirst Posted
Study publicly available on registry
January 28, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedResults Posted
Study results publicly available
April 4, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2023
CompletedMay 22, 2023
April 1, 2023
6.9 years
January 23, 2008
December 19, 2016
April 26, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
2-Year Progression Free Survival (PFS) Rate
Proportion of participants who were alive and progression free at 2 years.
2 years
Secondary Outcomes (5)
Overall Response Rate in Patients Without Del(11q22.3)
Up to 15 years
Overall Response Rates in Patients With Del(11q22.3)
Up to 15 years
PFS Rate of Patients With Del(11q22.3)
2 years
Time-to-progression in Patients Without Del(11q22.3)
Up to 15 years
Time-to-progression in Patients With Del(11q22.3)
Up to 15 years
Study Arms (4)
Arm A (rituximab, fludarabine phosphate)
ACTIVE COMPARATORParticipants receive induction therapy (every 28 days for up to 6 cycles) of: Patients receive rituximab IV over 1-4 hours on days 1 (50 mg/m\^2), 3 (325 mg/m\^2), and 5 (375 mg/m\^2) of course 1 and on day 1 (375 mg/m\^2) of all subsequent courses. Patients also receive fludarabine phosphate 25 mg/m\^2/day IV over 30 minutes or PO on days 1-5.
Arm B (rituximab, fludarabine phosphate, lenalidomide)
EXPERIMENTALParticipants receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 1-4 hours on days 1 (50 mg/m\^2), 3 (325 mg/m\^2), and 5 (375 mg/m\^2) of course 1 and on day 1 (375 mg/m\^2) of all subsequent courses. Patients also receive fludarabine phosphate 25 mg/m\^2/day IV over 30 minutes or PO on days 1-5. Participants without progression receive consolidation therapy lenalidomide 5mg/day cycle 1, 10 mg/day cycles 2-6 PO QD on days 1-21 of 28 day cycle.
Arm C (rituximab, fludarabine phosphate, cyclophosphamide)
EXPERIMENTALParticipants receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 4 hours on days 1 (50mg/m\^2) and 3 (325 mg/m\^2) of course 1 and on day 1 (500 mg/m\^2) of all subsequent courses. Patients then receive fludarabine phosphate (age \< 70: 25 mg/m\^2/day; age \>= 70: 20 mg/m\^2/day) IV piggyback over 30 minutes or PO (32 mg/m\^2/day) followed by cyclophosphamide (age \< 70: 250 mg/m\^2/day; age \>= 70: 150 mg/m\^2/day) IV piggyback over 30 minutes on days 1-3.
Arm D (rituximab, fludarabine, cyclophosphamide, lenalidomide)
EXPERIMENTALPatients receive the first course of induction therapy as in Arm A or B before being re-assigned to Arm D. Beginning in course 2, patients receive rituximab IV (500 mg/m\^2) on day 1 and fludarabine phosphate (age \< 70: 25 mg/m\^2/day; age \>= 70: 20 mg/m\^2/day) IV piggyback over 30 minutes or PO (32 mg/m\^2/day) and cyclophosphamide IV (age \< 70: 250 mg/m\^2/day; age \>= 70: 150 mg/m\^2/day) piggyback over 30 minutes on days 1-3. Participants without progression receive consolidation therapy: lenalidomide 5mg/day cycle 1, 10 mg/day cycles 2-6PO QD on days 1-21 of 28 day cycle.
Interventions
Given IV
Given IV or PO
Correlative studies
Given PO
Given IV
Eligibility Criteria
You may qualify if:
- Specific diagnosis of B-cell CLL:
- An absolute lymphocytosis of \> 5,000/uL
- Morphologically, the lymphocytes must appear mature with \< 55% prolymphocytes
- Bone marrow examination must include at least a unilateral aspirate and biopsy; the aspirate smear must show \> 30% of all nucleated cells to be lymphoid or the bone marrow core biopsy must show lymphoid infiltrates compatible with marrow involvement by CLL; overall cellularity must be normocellular or hypercellular
- Local institution lymphocyte phenotype must reveal a predominant B-cell monoclonal population sharing a B-cell marker (cluster of differentiation \[CD\]19, CD20, CD23) with the CD5 antigen, in the absence of other pan-T-cell markers; additionally, the B-cells must be monoclonal with regard to expression of either kappa or lambda and have surface immunoglobulin expression of low density; patients with bright surface immunoglobulin levels must have CD23 co-expression
- Patients must have symptomatic and active intermediate or high-risk categories of the modified three-stage Rai staging system:
- Not eligible: low risk, Rai stage 0, lymphocytes (L) in blood (\> 5000/uL) and marrow (\> 30%) only
- Intermediate risk, Rai stage I, L + enlarged lymph nodes (LN)
- Intermediate risk, Rai stage II, L + spleen and/or liver (LN + or -)
- High risk, Rai stage III, L + anemia (hemoglobin \< 11 gm/dL)
- High risk, Rai stage IV, L + thrombocytopenia (platelets \< 100,000/uL)
- Patients in the intermediate-risk group must have evidence of active disease as demonstrated by at least one of the following criteria:
- Massive or progressive splenomegaly, hepatomegaly and/or lymphadenopathy
- Presence of weight loss \> 10% over the preceding 6 month period
- Grade 2 or 3 fatigue
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Cancer Institute (NCI)lead
- Eastern Cooperative Oncology Groupcollaborator
- NCIC Clinical Trials Groupcollaborator
- SWOG Cancer Research Networkcollaborator
Study Sites (364)
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
PCR Oncology
Arroyo Grande, California, 93420, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, 91505, United States
Palo Alto Medical Foundation-Camino Division
Mountain View, California, 94040, United States
Palo Alto Medical Foundation Health Care
Palo Alto, California, 94301, United States
UCSF Medical Center-Mount Zion
San Francisco, California, 94115, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, 06105, United States
Norwalk Hospital
Norwalk, Connecticut, 06856, United States
Smilow Cancer Hospital-Torrington Care Center
Torrington, Connecticut, 06790, United States
Beebe Medical Center
Lewes, Delaware, 19958, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016, United States
Jupiter Medical Center
Jupiter, Florida, 33458, United States
Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
Orlando Health Cancer Institute
Orlando, Florida, 32806, United States
Saint Anthony's Health
Alton, Illinois, 62002, United States
Rush - Copley Medical Center
Aurora, Illinois, 60504, United States
MacNeal Hospital and Cancer Center
Berwyn, Illinois, 60402, United States
Saint Joseph Medical Center
Bloomington, Illinois, 61701, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704, United States
Graham Hospital Association
Canton, Illinois, 61520, United States
Illinois CancerCare-Canton
Canton, Illinois, 61520, United States
Illinois CancerCare-Carthage
Carthage, Illinois, 62321, United States
Memorial Hospital
Carthage, Illinois, 62321, United States
Hematology and Oncology Associates
Chicago, Illinois, 60611, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
Weiss Memorial Hospital
Chicago, Illinois, 60640, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Heartland Cancer Research NCORP
Decatur, Illinois, 62526, United States
Ascension Alexian Brothers - Elk Grove Village
Elk Grove Village, Illinois, 60007, United States
Eureka Hospital
Eureka, Illinois, 61530, United States
Illinois CancerCare-Eureka
Eureka, Illinois, 61530, United States
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, 60201, United States
Galesburg Cottage Hospital
Galesburg, Illinois, 61401, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401, United States
Illinois CancerCare-Havana
Havana, Illinois, 62644, United States
Mason District Hospital
Havana, Illinois, 62644, United States
Hematology Oncology Associates of Illinois-Highland Park
Highland Park, Illinois, 60035, United States
Hopedale Medical Complex - Hospital
Hopedale, Illinois, 61747, United States
Midwest Center for Hematology Oncology
Joliet, Illinois, 60432, United States
Duly Health and Care Joliet
Joliet, Illinois, 60435, United States
Presence Saint Mary's Hospital
Kankakee, Illinois, 60901, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443, United States
AMG Libertyville - Oncology
Libertyville, Illinois, 60048, United States
Illinois CancerCare-Macomb
Macomb, Illinois, 61455, United States
Mcdonough District Hospital
Macomb, Illinois, 61455, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Holy Family Medical Center
Monmouth, Illinois, 61462, United States
Illinois CancerCare-Monmouth
Monmouth, Illinois, 61462, United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, 62864, United States
DuPage Medical Group-Ogden
Naperville, Illinois, 60563, United States
Illinois Cancer Specialists-Niles
Niles, Illinois, 60714, United States
Bromenn Regional Medical Center
Normal, Illinois, 61761, United States
Carle Cancer Institute Normal
Normal, Illinois, 61761, United States
Illinois CancerCare-Community Cancer Center
Normal, Illinois, 61761, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350, United States
Ottawa Regional Hospital and Healthcare Center
Ottawa, Illinois, 61350, United States
Illinois CancerCare-Pekin
Pekin, Illinois, 61554, United States
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Pekin, Illinois, 61554, United States
Pekin Hospital
Pekin, Illinois, 61554, United States
Proctor Hospital
Peoria, Illinois, 61614, United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615, United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61636, United States
OSF Saint Francis Medical Center
Peoria, Illinois, 61637, United States
Illinois CancerCare-Peru
Peru, Illinois, 61354, United States
Illinois Valley Hospital
Peru, Illinois, 61354, United States
Illinois CancerCare-Princeton
Princeton, Illinois, 61356, United States
Perry Memorial Hospital
Princeton, Illinois, 61356, United States
Swedish American Hospital
Rockford, Illinois, 61104, United States
OSF Saint Anthony Medical Center
Rockford, Illinois, 61108, United States
Hematology Oncology Associates of Illinois - Skokie
Skokie, Illinois, 60076, United States
Illinois CancerCare-Spring Valley
Spring Valley, Illinois, 61362, United States
Saint Margaret's Hospital
Spring Valley, Illinois, 61362, United States
Memorial Medical Center
Springfield, Illinois, 62781, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555, United States
Franciscan Saint Francis Health-Beech Grove
Beech Grove, Indiana, 46107, United States
Elkhart Clinic
Elkhart, Indiana, 46514-2098, United States
Michiana Hematology Oncology PC-Elkhart
Elkhart, Indiana, 46514, United States
Elkhart General Hospital
Elkhart, Indiana, 46515, United States
Fort Wayne Medical Oncology and Hematology Inc-Parkview
Fort Wayne, Indiana, 46845, United States
Community Howard Regional Health
Kokomo, Indiana, 46904, United States
IU Health La Porte Hospital
La Porte, Indiana, 46350, United States
Franciscan Saint Anthony Health-Michigan City
Michigan City, Indiana, 46360, United States
Michiana Hematology Oncology PC-Mishawaka
Mishawaka, Indiana, 46545, United States
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, 46545, United States
Michiana Hematology Oncology PC-Plymouth
Plymouth, Indiana, 46563, United States
Reid Health
Richmond, Indiana, 47374, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
Michiana Hematology Oncology PC-South Bend
South Bend, Indiana, 46601, United States
South Bend Clinic
South Bend, Indiana, 46617, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46628, United States
Michiana Hematology Oncology PC-Westville
Westville, Indiana, 46391, United States
McFarland Clinic PC - Ames
Ames, Iowa, 50010, United States
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, 50325, United States
Mercy Capitol
Des Moines, Iowa, 50307, United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
Iowa-Wide Oncology Research Coalition NCORP
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, 50309, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
Mission Cancer and Blood - Laurel
Des Moines, Iowa, 50314, United States
Iowa Lutheran Hospital
Des Moines, Iowa, 50316, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242, United States
Iowa City VA Healthcare System
Iowa City, Iowa, 52246, United States
Ottumwa Regional Health Center
Ottumwa, Iowa, 52501, United States
Siouxland Regional Cancer Center
Sioux City, Iowa, 51101, United States
Mercy Medical Center-Sioux City
Sioux City, Iowa, 51102, United States
Saint Luke's Regional Medical Center
Sioux City, Iowa, 51104, United States
HaysMed University of Kansas Health System
Hays, Kansas, 67601, United States
Hutchinson Regional Medical Center
Hutchinson, Kansas, 67502, United States
Providence Medical Center
Kansas City, Kansas, 66112, United States
University of Kansas Cancer Center
Kansas City, Kansas, 66160, United States
Lawrence Memorial Hospital
Lawrence, Kansas, 66044, United States
Olathe Cancer Center
Olathe, Kansas, 66061, United States
Menorah Medical Center
Overland Park, Kansas, 66209, United States
Radiation Oncology Practice Corporation Southwest
Overland Park, Kansas, 66210, United States
Saint Luke's South Hospital
Overland Park, Kansas, 66213, United States
Ascension Via Christi - Pittsburg
Pittsburg, Kansas, 66762, United States
Kansas City NCI Community Oncology Research Program
Prairie Village, Kansas, 66208, United States
Salina Regional Health Center
Salina, Kansas, 67401, United States
Advent Health - Shawnee Mission Medical Center
Shawnee Mission, Kansas, 66204, United States
Cotton O'Neil Cancer Center / Stormont Vail Health
Topeka, Kansas, 66606, United States
University of Kansas Health System Saint Francis Campus
Topeka, Kansas, 66606, United States
Wesley Medical Center
Wichita, Kansas, 67214, United States
Doctors Carrol, Sheth, Raghavan
Louisville, Kentucky, 40215, United States
Harold Alfond Center for Cancer Care
Augusta, Maine, 04330, United States
Eastern Maine Medical Center
Bangor, Maine, 04401, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-5600, United States
Christiana Care - Union Hospital
Elkton, Maryland, 21921, United States
Unspecified Site
Rockville, Maryland, 20852, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Green Bay Oncology - Escanaba
Escanaba, Michigan, 49829, United States
Cancer Research Consortium of West Michigan NCORP
Grand Rapids, Michigan, 49503, United States
Green Bay Oncology - Iron Mountain
Iron Mountain, Michigan, 49801, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
Borgess Medical Center
Kalamazoo, Michigan, 49048, United States
Lakeland Hospital Niles
Niles, Michigan, 49120, United States
Lakeland Medical Center Saint Joseph
Saint Joseph, Michigan, 49085, United States
Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Unity Hospital
Fridley, Minnesota, 55432, United States
Hutchinson Area Health Care
Hutchinson, Minnesota, 55350, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Virginia Piper Cancer Institute
Minneapolis, Minnesota, 55407, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
Minneapolis VA Medical Center
Minneapolis, Minnesota, 55417, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422, United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park, Minnesota, 55416, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379, United States
Lakeview Hospital
Stillwater, Minnesota, 55082, United States
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
Rice Memorial Hospital
Willmar, Minnesota, 56201, United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, 55125, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703, United States
Southeast Cancer Center
Cape Girardeau, Missouri, 63703, United States
University of Missouri - Ellis Fischel
Columbia, Missouri, 65212, United States
Centerpoint Medical Center LLC
Independence, Missouri, 64057, United States
Capital Region Southwest Campus
Jefferson City, Missouri, 65109, United States
Truman Medical Centers
Kansas City, Missouri, 64108, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111, United States
Radiation Oncology Practice Corporation South
Kansas City, Missouri, 64114, United States
Saint Joseph Health Center
Kansas City, Missouri, 64114, United States
North Kansas City Hospital
Kansas City, Missouri, 64116, United States
Heartland Hematology and Oncology Associates Incorporated
Kansas City, Missouri, 64118, United States
Research Medical Center
Kansas City, Missouri, 64132, United States
Radiation Oncology Practice Corporation - North
Kansas City, Missouri, 64154, United States
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, 64086, United States
Liberty Radiation Oncology Center
Liberty, Missouri, 64068, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, 64506, United States
Saint Joseph Oncology Inc
Saint Joseph, Missouri, 64507, United States
Mercy Hospital Springfield
Springfield, Missouri, 65804, United States
CoxHealth South Hospital
Springfield, Missouri, 65807, United States
SSM Health Saint Louis University Hospital
St Louis, Missouri, 63104, United States
Saint Louis Cancer and Breast Institute-South City
St Louis, Missouri, 63109, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Missouri Baptist Medical Center
St Louis, Missouri, 63131, United States
Center for Cancer Care and Research
St Louis, Missouri, 63141, United States
Comprehensive Cancer Care PC
St Louis, Missouri, 63141, United States
Mercy Hospital Saint Louis
St Louis, Missouri, 63141, United States
Saint Louis-Cape Girardeau CCOP
St Louis, Missouri, 63141, United States
Billings Clinic Cancer Center
Billings, Montana, 59101, United States
Saint Vincent Healthcare
Billings, Montana, 59101, United States
Montana Cancer Consortium NCORP
Billings, Montana, 59102, United States
Saint Vincent Frontier Cancer Center
Billings, Montana, 59102, United States
Bozeman Deaconess Hospital
Bozeman, Montana, 59715, United States
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, 59701, United States
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, 59405, United States
Great Falls Clinic
Great Falls, Montana, 59405, United States
Northern Montana Hospital
Havre, Montana, 59501, United States
Saint Peter's Community Hospital
Helena, Montana, 59601, United States
Glacier Oncology PLLC
Kalispell, Montana, 59901, United States
Kalispell Medical Oncology
Kalispell, Montana, 59901, United States
Kalispell Regional Medical Center
Kalispell, Montana, 59901, United States
Montana Cancer Specialists
Missoula, Montana, 59802, United States
Saint Patrick Hospital - Community Hospital
Missoula, Montana, 59802, United States
CHI Health Saint Francis
Grand Island, Nebraska, 68803, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102, United States
Nevada Cancer Research Foundation NCORP
Las Vegas, Nevada, 89169, United States
New Hampshire Oncology Hematology PA-Concord
Concord, New Hampshire, 03301, United States
LRGHealthcare-Lakes Region General Hospital
Laconia, New Hampshire, 03246, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756, United States
Norris Cotton Cancer Center-Manchester
Manchester, New Hampshire, 03102, United States
Solinsky Center for Cancer Care
Manchester, New Hampshire, 03103, United States
Cooper Hospital University Medical Center
Camden, New Jersey, 08103, United States
Veterans Adminstration New Jersey Health Care System
East Orange, New Jersey, 07018-1095, United States
Virtua Memorial
Mount Holly, New Jersey, 08060, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
Saint Joseph's Regional Medical Center
Paterson, New Jersey, 07503, United States
Virtua Voorhees
Voorhees Township, New Jersey, 08043, United States
Lovelace Medical Center-Saint Joseph Square
Albuquerque, New Mexico, 87102, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87102, United States
Memorial Medical Center - Las Cruces
Las Cruces, New Mexico, 88011, United States
Hematology Oncology Associates of Central New York-East Syracuse
East Syracuse, New York, 13057, United States
Northwell Health NCORP
Lake Success, New York, 11042, United States
Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
Long Island Jewish Medical Center
New Hyde Park, New York, 11040, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016, United States
Mount Sinai Hospital
New York, New York, 10029, United States
NYP/Weill Cornell Medical Center
New York, New York, 10065, United States
University of Rochester
Rochester, New York, 14642, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
State University of New York Upstate Medical University
Syracuse, New York, 13210, United States
Montefiore Medical Center-Weiler Hospital
The Bronx, New York, 10461, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467, United States
Randolph Hospital
Asheboro, North Carolina, 27203, United States
Mission Hospital
Asheville, North Carolina, 28801, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203, United States
Wayne Memorial Hospital
Goldsboro, North Carolina, 27534, United States
Cone Health Cancer Center
Greensboro, North Carolina, 27403, United States
East Carolina University
Greenville, North Carolina, 27834, United States
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, 28791, United States
Vidant Oncology-Kinston
Kinston, North Carolina, 28501, United States
Annie Penn Memorial Hospital
Reidsville, North Carolina, 27320, United States
Iredell Memorial Hospital
Statesville, North Carolina, 28677, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Mary Rutan Hospital
Bellefontaine, Ohio, 43311, United States
Aultman Health Foundation
Canton, Ohio, 44710, United States
Adena Regional Medical Center
Chillicothe, Ohio, 45601, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Columbus NCI Community Oncology Research Program
Columbus, Ohio, 43215, United States
Grant Medical Center
Columbus, Ohio, 43215, United States
Mount Carmel Health Center West
Columbus, Ohio, 43222, United States
Doctors Hospital
Columbus, Ohio, 43228, United States
Grandview Hospital
Dayton, Ohio, 45405, United States
Good Samaritan Hospital - Dayton
Dayton, Ohio, 45406, United States
Miami Valley Hospital
Dayton, Ohio, 45409, United States
Miami Valley Hospital North
Dayton, Ohio, 45415, United States
Dayton NCI Community Oncology Research Program
Dayton, Ohio, 45459, United States
Grady Memorial Hospital
Delaware, Ohio, 43015, United States
Blanchard Valley Hospital
Findlay, Ohio, 45840, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066, United States
Wayne Hospital
Greenville, Ohio, 45331, United States
Kettering Medical Center
Kettering, Ohio, 45429, United States
Fairfield Medical Center
Lancaster, Ohio, 43130, United States
Marietta Memorial Hospital
Marietta, Ohio, 45750, United States
Knox Community Hospital
Mount Vernon, Ohio, 43050, United States
Licking Memorial Hospital
Newark, Ohio, 43055, United States
Springfield Regional Medical Center
Springfield, Ohio, 45505, United States
Upper Valley Medical Center
Troy, Ohio, 45373, United States
Saint Ann's Hospital
Westerville, Ohio, 43081, United States
Clinton Memorial Hospital
Wilmington, Ohio, 45177, United States
Greene Memorial Hospital
Xenia, Ohio, 45385, United States
Genesis Healthcare System Cancer Care Center
Zanesville, Ohio, 43701, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Easton Hospital
Easton, Pennsylvania, 18042, United States
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, 18201, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
Lewistown Hospital
Lewistown, Pennsylvania, 17044, United States
Paoli Memorial Hospital
Paoli, Pennsylvania, 19301, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Pottstown Hospital
Pottstown, Pennsylvania, 19464, United States
Geisinger Medical Group
State College, Pennsylvania, 16801, United States
Mount Nittany Medical Center
State College, Pennsylvania, 16803, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711, United States
Geisinger South Wilkes-Barre
Wilkes-Barre, Pennsylvania, 18765, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096, United States
Main Line Health NCORP
Wynnewood, Pennsylvania, 19096, United States
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Prisma Health Cancer Institute - Easley
Easley, South Carolina, 29640, United States
McLeod Regional Medical Center
Florence, South Carolina, 29506, United States
Greenville Health System Cancer Institute-Andrews
Greenville, South Carolina, 29601, United States
Saint Francis Hospital
Greenville, South Carolina, 29601, United States
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, 29605, United States
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605, United States
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, 29605, United States
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615, United States
Self Regional Healthcare
Greenwood, South Carolina, 29646, United States
Prisma Health Cancer Institute - Greer
Greer, South Carolina, 29650, United States
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, 29672, United States
Thompson Cancer Survival Center
Knoxville, Tennessee, 37916, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont, 05602, United States
University of Vermont and State Agricultural College
Burlington, Vermont, 05405, United States
Norris Cotton Cancer Center-North
Saint Johnsbury, Vermont, 05819, United States
Danville Regional Medical Center
Danville, Virginia, 24541, United States
Sovah Health Martinsville
Martinsville, Virginia, 24115, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298, United States
West Virginia University Healthcare
Morgantown, West Virginia, 26506, United States
Wheeling Hospital/Schiffler Cancer Center
Wheeling, West Virginia, 26003, United States
Marshfield Clinic-Chippewa Center
Chippewa Falls, Wisconsin, 54729, United States
HSHS Sacred Heart Hospital
Eau Claire, Wisconsin, 54701, United States
Marshfield Clinic Cancer Center at Sacred Heart
Eau Claire, Wisconsin, 54701, United States
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, 54301-3526, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301, United States
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin, 54303, United States
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303, United States
UW Cancer Center Johnson Creek
Johnson Creek, Wisconsin, 53038, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792, United States
Holy Family Memorial Hospital
Manitowoc, Wisconsin, 54221, United States
Bay Area Medical Center
Marinette, Wisconsin, 54143, United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449, United States
Marshfield Medical Center
Marshfield, Wisconsin, 54449, United States
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, 54548, United States
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, 53066, United States
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin, 54154, United States
Ascension Saint Mary's Hospital
Rhinelander, Wisconsin, 54501, United States
Saint Mary's Hospital
Rhinelander, Wisconsin, 54501, United States
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868, United States
HSHS Saint Nicholas Hospital
Sheboygan, Wisconsin, 53081, United States
Ascension Saint Michael's Hospital
Stevens Point, Wisconsin, 54481, United States
Green Bay Oncology - Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235, United States
ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin, 53188, United States
Diagnostic and Treatment Center
Weston, Wisconsin, 54476, United States
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476, United States
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, 54494, United States
Rocky Mountain Oncology
Casper, Wyoming, 82609, United States
Welch Cancer Center
Sheridan, Wyoming, 82801, United States
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
QEII Health Sciences Centre/Nova Scotia Health Authority
Halifax, Nova Scotia, B3H 2Y9, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, L8V 5C2, Canada
University Health Network-Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
CSSS Champlain-Charles Le Moyne
Greenfield Park, Quebec, J4V 2H1, Canada
McGill University Health Centre at Royal Victoria Hospital
Montreal, Quebec, H3A 1A1, Canada
CHU de Quebec-Hopital du Saint-Sacrement (HSS)
Québec, Quebec, G1S 4L8, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- John Byrd, M.D.
- Organization
- Ohio State University
Study Officials
- PRINCIPAL INVESTIGATOR
John C Byrd
Alliance for Clinical Trials in Oncology
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2008
First Posted
January 28, 2008
Study Start
January 15, 2008
Primary Completion
December 1, 2014
Study Completion
April 15, 2023
Last Updated
May 22, 2023
Results First Posted
April 4, 2017
Record last verified: 2023-04