A Phase II Trial of PET-Directed Therapy for Limited Stage Diffuse Large B-Cell Lymphoma (DLBCL)
OBJECTIVES:
Primary
- To assess the 5-year progression-free survival (PFS) rate in patients with newly
diagnosed limited-stage diffuse, large B-cell lymphoma (DLBCL) using positron emission
tomography (PET)/CT scan to direct therapy after 3 courses of rituximab,
cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone
(R-CHOP).
Secondary
- To evaluate PFS within the PET-positive (+) and PET-negative (-) subgroups of patients
with newly diagnosed limited-stage DLBCL.
- To evaluate toxicity of the protocol treatments in this patient population.
- To evaluate the response probability in this patient population.
- To evaluate overall survival in the overall population, and within the PET+ and PET-
subgroups.
- To estimate the rate of upstaging at baseline by PET/CT at baseline among patients
newly diagnosed with limited-stage DLBCL by CT imaging and to describe outcomes in
patients upstaged by PET/CT at baseline to advanced DLBCL.
- To describe outcomes in the subgroup of patients upstaged by PET/CT.
- To evaluate the association of germinal center B-cell subtype (GCB) vs stromal-1 vs
stromal-2 gene expression signatures with PFS or overall survival.
OUTLINE: This is a multicenter study. Patients are stratified according to whether the
patient was upstaged to advanced stage DLBCL, based on local review of the baseline PET/CT
(yes vs no).
Chemotherapy: Patients receive R-CHOP comprising rituximab IV, cyclophosphamide IV over
30-60 minutes, vincristine sulfate IV, and doxorubicin hydrochloride IV on day 1, and
prednisone orally on days 1-5. Treatment repeats every 21 days for 3* courses. NOTE:
*Patients found to have advanced stage DLBCL based on local review of the baseline PET scan
receive 6 courses of R-CHOP.
FDG/PET - Radiotherapy: Patients undergo fludeoxyglucose F 18 positron emission tomography
(FDG-PET)/CT scan at baseline, on days 15-18 of course 3, and at 12 weeks after completion
of course 3. Patients with complete response (PET scan negative) receive one additional
course of R-CHOP as above. Patients with partial response (PET scan positive) undergo
involved-field radiotherapy (IFRT) 5 days a week for approximately 4-5 weeks.
Monoclonal antibody: Beginning 3-6 weeks after completion of IFRT, patients receive yttrium
Y 90 ibritumomab tiuxetan IV over 10 minutes and rituximab IV on day 1 and on day 7, 8, or
9.
Patients may undergo blood sample collection at baseline for correlative studies. Bone
marrow tissue samples may be also collected for correlative studies.
After completion of study therapy, patients are followed up every 6 months for 2 years and
then yearly for 5 years.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Five-year PFS rate of patients with DLBCL
No
Daniel O. Persky, MD
Principal Investigator
Yale University
Unspecified
CDR0000700624
NCT01359592
September 2011
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
Hurley Medical Center | Flint, Michigan 48503 |
University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
CCOP - Atlanta Regional | Atlanta, Georgia 30342-1701 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Aurora Presbyterian Hospital | Aurora, Colorado 80012 |
Boulder Community Hospital | Boulder, Colorado 80301-9019 |
Penrose Cancer Center at Penrose Hospital | Colorado Springs, Colorado 80933 |
CCOP - Colorado Cancer Research Program | Denver, Colorado 80224-2522 |
Porter Adventist Hospital | Denver, Colorado 80210 |
Presbyterian - St. Luke's Medical Center | Denver, Colorado 80218 |
St. Joseph Hospital | Denver, Colorado 80218 |
Rose Medical Center | Denver, Colorado 80220 |
Swedish Medical Center | Englewood, Colorado 80110 |
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center | Grand Junction, Colorado 81502 |
Sky Ridge Medical Center | Lone Tree, Colorado 80124 |
Hope Cancer Care Center at Longmont United Hospital | Longmont, Colorado 80502 |
St. Mary - Corwin Regional Medical Center | Pueblo, Colorado 81004 |
North Suburban Medical Center | Thornton, Colorado 80229 |
Mercy Medical Center - Sioux City | Sioux City, Iowa 51104 |
Siouxland Hematology-Oncology Associates, LLP | Sioux City, Iowa 51101 |
St. Luke's Regional Medical Center | Sioux City, Iowa 51104 |
CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
Saint Joseph Mercy Cancer Center | Ann Arbor, Michigan 48106-0995 |
Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn, Michigan 48123-2500 |
Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Borgess Medical Center | Kalamazooaa, Michigan 49001 |
Sparrow Regional Cancer Center | Lansing, Michigan 48912-1811 |
St. John Macomb Hospital | Warren, Michigan 48093 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids, Minnesota 55433 |
Duluth Clinic Cancer Center - Duluth | Duluth, Minnesota 55805-1983 |
CCOP - Duluth | Duluth, Minnesota 55805 |
Miller - Dwan Medical Center | Duluth, Minnesota 55805 |
Fairview Southdale Hospital | Edina, Minnesota 55435 |
Mercy and Unity Cancer Center at Unity Hospital | Fridley, Minnesota 55432 |
Hutchinson Area Health Care | Hutchinson, Minnesota 55350 |
HealthEast Cancer Care at St. John's Hospital | Maplewood, Minnesota 55109 |
Hennepin County Medical Center - Minneapolis | Minneapolis, Minnesota 55415 |
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis, Minnesota 55407 |
St. Francis Cancer Center at St. Francis Medical Center | Shakopee, Minnesota 55379 |
Park Nicollet Cancer Center | St. Louis Park, Minnesota 55416 |
Regions Hospital Cancer Care Center | St. Paul, Minnesota 55101 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
MeritCare Broadway | Fargo, North Dakota 58122 |
CCOP - MeritCare Hospital | Fargo, North Dakota 58122 |
Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa, Oklahoma 74136 |
Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls, South Dakota 57117-5039 |
Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
CCOP - Dayton | Kettering, Ohio 45429 |
CCOP - Greenville | Greenville, South Carolina 29615 |
Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |
Arizona Cancer Center at University of Arizona Health Sciences Center | Tucson, Arizona 85724 |
Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan 48202 |
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle, Washington 98104 |
Northside Hospital Cancer Center | Atlanta, Georgia 30342-1611 |
Yale Cancer Center | New Haven, Connecticut 06520-8028 |
Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Mary Babb Randolph Cancer Center at West Virginia University Hospitals | Morgantown, West Virginia 26506 |
James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
North Colorado Medical Center | Greeley, Colorado 80631 |
McKee Medical Center | Loveland, Colorado 80539 |
Hematology-Oncology Centers of the Northern Rockies - Billings | Billings, Montana 59101 |
St. Peter's Hospital | Helena, Montana 59601 |
Kalispell Regional Medical Center | Kalispell, Montana 59901 |
Glacier Oncology, PLLC | Kalispell, Montana 59901 |
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula, Montana 59802 |
Montana Cancer Specialists at Montana Cancer Center | Missoula, Montana 59802 |
Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
Olympic Hematology and Oncology | Bremerton, Washington 98310 |
Skagit Valley Hospital Cancer Care Center | Mt. Vernon, Washington 98273 |
University Cancer Center at University of Washington Medical Center | Seattle, Washington 98195 |
Harborview Medical Center | Seattle, Washington 98104 |
Group Health Central Hospital | Seattle, Washington 98104 |
North Puget Oncology at United General Hospital | Sedro-Wooley, Washington 98284 |
Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
Mountain States Tumor Institute at St. Luke's Regional Medical Center | Boise, Idaho 83712-6297 |
Lucille P. Markey Cancer Center at University of Kentucky | Lexington, Kentucky 40536-0093 |
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St. Louis, Missouri 63110 |
Geisinger Cancer Institute at Geisinger Health | Danville, Pennsylvania 17822-0001 |
Gundersen Lutheran Center for Cancer and Blood | La Crosse, Wisconsin 54601 |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
Hematology Oncology Associates - Skokie | Skokie, Illinois 60076 |
Saint Joseph's Hospital of Atlanta | Atlanta, Georgia 30342-1701 |
Piedmont Hospital | Atlanta, Georgia 30309 |
WellStar Cobb Hospital | Austell, Georgia 30106 |
Charles B. Eberhart Cancer Center at DeKalb Medical Center | Decatur, Georgia 30033 |
Gwinnett Medical Center | Lawrenceville, Georgia 30045 |
Kennestone Cancer Center at Wellstar Kennestone Hospital | Marietta, Georgia 30060 |
Southern Regional Medical Center | Riverdale, Georgia 30274-2600 |
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center | Boise, Idaho 83706 |
St. Joseph Medical Center | Bloomington, Illinois 61701 |
Graham Hospital | Canton, Illinois 61520 |
Memorial Hospital | Carthage, Illinois 62321 |
Hematology and Oncology Associates | Chicago, Illinois 60611 |
Eureka Community Hospital | Eureka, Illinois 61530 |
North Shore Oncology and Hematology Associates, Limited - Libertyville | Libertyville, Illinois 60048 |
McDonough District Hospital | Macomb, Illinois 61455 |
BroMenn Regional Medical Center | Normal, Illinois 61761 |
Community Cancer Center | Normal, Illinois 61761 |
Community Hospital of Ottawa | Ottawa, Illinois 61350 |
Oncology Hematology Associates of Central Illinois, PC - Ottawa | Ottawa, Illinois 61350 |
Cancer Treatment Center at Pekin Hospital | Pekin, Illinois 61554 |
Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria, Illinois 61615 |
OSF St. Francis Medical Center | Peoria, Illinois 61637 |
Proctor Hospital | Peoria, Illinois 61614 |
Illinois Valley Community Hospital | Peru, Illinois 61354 |
Perry Memorial Hospital | Princeton, Illinois 61356 |
St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove, Indiana 46107 |
Cancer Center of Kansas, PA - Dodge City | Dodge City, Kansas 67801 |
Iredell Memorial Hospital | Statesville, North Carolina 28677 |
Samaritan North Cancer Care Center | Dayton, Ohio 45415 |
Grandview Hospital | Dayton, Ohio 45405 |
David L. Rike Cancer Center at Miami Valley Hospital | Dayton, Ohio 45409 |
Good Samaritan Hospital | Dayton, Ohio 45406 |
Blanchard Valley Medical Associates | Findlay, Ohio 45840 |
Charles F. Kettering Memorial Hospital | Kettering, Ohio 45429 |
Middletown Regional Hospital | Middletown, Ohio 45044 |
UVMC Cancer Care Center at Upper Valley Medical Center | Troy, Ohio 45373-1300 |
Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia, Ohio 45385 |
Cancer Therapy and Research Center | San Antonio, Texas 78229 |
University Hospital - San Antonio | San Antonio, Texas 78229 |
Minor and James Medical, PLLC | Seattle, Washington 98104 |
Polyclinic First Hill | Seattle, Washington 98122 |
St. Anthony Central Hospital | Denver, Colorado 80204-1335 |
Exempla Lutheran Medical Center | Wheat Ridge, Colorado 80033 |
Kaiser Permanente - Denver | Denver, Colorado 80205 |
Kaiser Permanente - Lafayette | Lafayette, Colorado 80026 |
John B. Amos Cancer Center | Columbus, Georgia 31904 |
Harbin Clinic Cancer Center - Medical Oncology | Rome, Georgia 30165 |
Kellogg Cancer Care Center | Highland Park, Illinois 60035 |
Cancer Care and Hematology Specialists of Chicagoland - Niles | Niles, Illinois 60714 |
Reid Hospital & Health Care Services | Richmond, Indiana 47374 |
Cancer Center of Kansas, PA - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas, PA - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas - Fort Scott | Fort Scott, Kansas 66701 |
Cancer Center of Kansas-Independence | Independence, Kansas 67301 |
Cancer Center of Kansas, PA - Kingman | Kingman, Kansas 67068 |
Lawrence Memorial Hospital | Lawrence, Kansas 66044 |
Cancer Center of Kansas, PA - Liberal | Liberal, Kansas 67905 |
Cancer Center of Kansas, PA - Newton | Newton, Kansas 67114 |
Menorah Medical Center | Overland Park, Kansas 66209 |
Saint Luke's Hospital - South | Overland Park, Kansas 66213 |
Cancer Center of Kansas, PA - Parsons | Parsons, Kansas 67357 |
Cancer Center of Kansas, PA - Pratt | Pratt, Kansas 67124 |
Cancer Center of Kansas, PA - Salina | Salina, Kansas 67401 |
Cancer Center of Kansas, PA - Wellington | Wellington, Kansas 67152 |
Cancer Center of Kansas, PA - Wichita | Wichita, Kansas 67214 |
Associates in Womens Health, PA - North Review | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Medical Arts Tower | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Winfield | Winfield, Kansas 67156 |
Foote Memorial Hospital | Jackson, Michigan 49201 |
St. Mary Mercy Hospital | Livonia, Michigan 48154 |
St. Joseph Mercy Oakland | Pontiac, Michigan 48341-2985 |
Mercy Regional Cancer Center at Mercy Hospital | Port Huron, Michigan 48060 |
Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw, Michigan 48601 |
Willmar Cancer Center at Rice Memorial Hospital | Willmar, Minnesota 56201 |
Heartland Hematology Oncology Associates, Incorporated | Kansas City, Missouri 64118 |
North Kansas City Hospital | Kansas City, Missouri 64116 |
Saint Luke's Cancer Institute at Saint Luke's Hospital | Kansas City, Missouri 64111 |
Research Medical Center | Kansas City, Missouri 64132 |
Saint Luke's East - Lee's Summit | Lee's Summit, Missouri 64086 |
Heartland Regional Medical Center | Saint Joseph, Missouri 64506 |
Saint Joseph Oncology, Incorporated | Saint Joseph, Missouri 64507 |
Billings Clinic - Downtown | Billings, Montana 59107-7000 |
Bozeman Deaconess Cancer Center | Bozeman, Montana 59715 |
St. James Healthcare Cancer Care | Butte, Montana 59701 |
Great Falls Clinic - Main Facility | Great Falls, Montana 59405 |
Sletten Cancer Institute at Benefis Healthcare | Great Falls, Montana 59405 |
Kalispell Medical Oncology at KRMC | Kalispell, Montana 59901 |
Wayne Hospital | Greenville, Ohio 45331 |
St. Joseph Cancer Center | Bellingham, Washington 98225 |
Columbia Basin Hematology | Kennewick, Washington 99336 |
Harrison Poulsbo Hematology and Onocology | Poulsbo, Washington 98370 |
Evergreen Hematology and Oncology, PS | Spokane, Washington 99218 |
Wenatchee Valley Medical Center | Wenatchee, Washington 98801-2028 |
Rocky Mountain Oncology | Casper, Wyoming 82609 |
Genesys Regional Medical Center | Grand Blanc, Michigan 48439-8066 |
Queen's Cancer Institute at Queen's Medical Center | Honolulu, Hawaii 96813 |
Rex Cancer Center at Rex Hospital | Raleigh, North Carolina 27607 |
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
Greenville Hospital Cancer Center | Greenville, South Carolina 29605 |
Cancer Centers of the Carolinas - Grove Commons | Greenville, South Carolina 29605 |
Cancer Centers of the Carolinas - Faris Road | Greenville, South Carolina 29605 |
Cancer Centers of the Carolinas - Greer Medical Oncology | Greer, South Carolina 29650 |
Cancer Centers of the Carolinas - Seneca | Seneca, South Carolina 29672 |
Cancer Centers of the Carolinas - Spartanburg | Spartanburg, South Carolina 29307 |
Providence Cancer Center | Anchorage, Alaska 99508 |
Galesburg Clinic, PC | Galesburg, Illinois 61401 |
St. Vincent Healthcare Cancer Care Services | Billings, Montana 59101 |
Parvin Radiation Oncology | Kansas City, Missouri 64116 |
Kapiolani Medical Center at Pali Momi | Aiea, Hawaii 96701 |
Kapiolani Medical Center for Women and Children | Honolulu, Hawaii 96826 |
Straub Clinic and Hospital, Incorporated | Honolulu, Hawaii 96813 |
Hawaii Medical Center - East | Honolulu, Hawaii 96817 |
OnCare Hawaii, Incorporated - Kuakini | Honolulu, Hawaii 96817 |
OnCare Hawaii, Incorporated - Lusitana | Honolulu, Hawaii 96813 |
Illinois CancerCare - Bloomington | Bloomington%, Illinois 61701 |
Illinois CancerCare - Canton | Canton, Illinois 61520 |
Illinois CancerCare - Carthage | Carthage, Illinois 62321 |
Illinois CancerCare - Eureka | Eureka, Illinois 61530 |
Illinois CancerCare - Galesburg | Galesburg, Illinois 61401 |
Illinois CancerCare - Havana | Havana, Illinois 62644 |
Illinois CancerCare - Kewanee Clinic | Kewanee, Illinois 61443 |
Illinois CancerCare - Macomb | Macomb, Illinois 61455 |
OSF Holy Family Medical Center | Monmouth, Illinois 61462 |
Illinois CancerCare - Monmouth | Monmouth, Illinois 61462 |
Illinois CancerCare - Community Cancer Center | Normal, Illinois 61761 |
Illinois CancerCare - Pekin | Pekin, Illinois 61603 |
Illinois CancerCare - Peru | Peru, Illinois 61354 |
Illinois CancerCare - Princeton | Princeton, Illinois 61356 |
Illinois CancerCare - Spring Valley | Spring Valley, Illinois 61362 |
Provena St. Mary's Regional Cancer Center - Kankakee | Kankakee, Illinois 60901 |
Minnesota Oncology - Maplewood | Maplewood, Minnesota 55109 |
Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale, Minnesota 55422-2900 |
Lakeview Hospital | Stillwater, Minnesota 55082 |
Minnesota Oncology - Woodbury | Woodbury, Minnesota 55125 |
CCOP - Kansas City | Prairie Village, Kansas 66208 |
Piedmont Fayette Hospital | Fayetteville, Georgia 30214 |
Castle Medical Center | Kailua, Hawaii 96734 |
Kauai Medical Clinic | Lihue, Hawaii 96766 |
Island Hospital Cancer Care Center at Island Hospital | Anacortes, Washington 98221 |
Highline Medical Center Cancer Center | Burien, Washington 98166 |
Littleton Adventist Hospital | Littleton, Colorado 80122 |
Parker Adventist Hospital | Parker, Colorado 80138 |
New Ulm Medical Center | New Ulm, Minnesota 56073 |
Roger Maris Cancer Center at MeritCare Hospital | Fargo, North Dakota 58122 |
Kuakini Medical Center | Honolulu, Hawaii 96817 |
Cancer Center of Kansas, PA - McPherson | McPherson, Kansas 67460 |
Oncare Hawaii, Incorporated - Pali Momi | Aiea, Hawaii 96701 |
Leeward Radiation Oncology | Ewa Beach, Hawaii 96706 |