S1001 PET-Directed Therapy in Treating Patients With Limited-Stage Diffuse Large B-Cell Lymphoma

NCT01359592 | Completed Phase 2 Results

• 3 other identifiers: CDR0000700624S1001U10CA032102
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 240

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Comparing results of diagnostic procedures, such as PET scan and CT scan, done before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment. PURPOSE: This phase II trial studies how well PET-directed chemotherapy works in treating patients with limited-stage diffuse large B-cell lymphoma.

Conditions

Lymphoma

Keywords

stage I adult diffuse large cell lymphoma; contiguous stage II adult diffuse large cell lymphoma; noncontiguous stage II adult diffuse large cell lymphoma; stage III adult diffuse large cell lymphoma; stage IV adult diffuse large cell lymphoma

Outcome Measures

Primary Outcomes (1)

• Five-year Progression-free Survival (PFS) Rate in Patients With Newly Diagnosed Limited Stage Diffuse Large B-cell Lymphoma (DLBCL)

  Measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive without report of progression or relapse are censored at date of last contact. Progressions is defined using the 2007 revised Cheson et. Al. criteria, as ≥50% increase in the sum of the products of diameters (SPD) of target measurable lesions, appearance of any new bone marrow involvement, or appearance of any new lesion \>1.5 cm in the longest axis.

  up to 5 years

Secondary Outcomes (5)

• Progression-free Survival (PFS) Within the PET+ and PET- Subgroups of Patients With Newly Diagnosed Limited-stage Diffuse Large B-Cell Lymphoma (DLBCL)

  up to 5 years

• Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug

  up to 4 months or time of disease progression.

• Overall Survival of Patients With Newly Diagnosed Limited-stage Diffuse Large B-Cell Lymphoma (DLBCL)

  up to 5 years

• Response Rates in Patients With Newly Diagnosed Limited Stage Diffuse Large B-cell Lymphoma Using PET/CT Scan to Direct Therapy After 3 Cycles of R-CHOP

  Up to 4 months

• Association of Germinal Center B-cell Subtype (GCB) vs Stromal-1 vs Stromal-2 Gene Expression Signatures With PFS or Overall Survival.

  5 years

Study Arms (2)

PET Negative: R-CHOP

ACTIVE COMPARATOR

R-CHOP x 3 Cycles

Biological: rituximab; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: prednisone; Drug: vincristine sulfate; Other: R-CHOP regimen; Other: laboratory biomarker analysis

PET Positive: IFRT +Zevalin

EXPERIMENTAL

Standard IFRT+ Zevalin IV per ABW

Biological: rituximab; Other: laboratory biomarker analysis; Radiation: fludeoxyglucose F 18; Radiation: selective external radiation therapy; Radiation: yttrium Y 90 ibritumomab tiuxetan

Interventions

rituximab BIOLOGICAL

PET Negative: R-CHOP; PET Positive: IFRT +Zevalin

cyclophosphamide DRUG

PET Negative: R-CHOP

doxorubicin hydrochloride DRUG

PET Negative: R-CHOP

prednisone DRUG

PET Negative: R-CHOP

vincristine sulfate DRUG

PET Negative: R-CHOP

R-CHOP regimen OTHER

PET Negative: R-CHOP

laboratory biomarker analysis OTHER

PET Negative: R-CHOP; PET Positive: IFRT +Zevalin

fludeoxyglucose F 18 RADIATION

PET Positive: IFRT +Zevalin

selective external radiation therapy RADIATION

PET Positive: IFRT +Zevalin

yttrium Y 90 ibritumomab tiuxetan RADIATION

PET Positive: IFRT +Zevalin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Patients must have biopsy-proven diffuse large B-cell lymphoma (DLBCL) * Adequate sections or a paraffin block from the original diagnostic specimen must be submitted for review by the lymphoma pathology group * Lymphoma must express CD20 antigen by either flow cytometry using anti-CD20 antibodies or by immunoperoxidase staining of paraffin sections * Patients with primary mediastinal lymphoma or testicular lymphoma are not eligible * Patients must have non-bulky stage I or II disease by Ann Arbor classification * This staging excludes FDG-PET evaluation * Patients who have stage I or II non-bulky disease on diagnostic CT scan, but are upstaged to stage III or IV based on FDG-PET evaluation, are also eligible * Patients must have a diagnostic quality contrast-enhanced CT scan of the chest, abdomen, and pelvis AND baseline FDG-PET scan performed within 28 days prior to registration * Low-resolution "localization" CT scans performed as part of a combined PET/CT scan are not adequate for enrollment or response determination on this protocol * If a patient has an allergy to CT contrast, then a non-enhanced CT will be acceptable * Patients must not have clinical evidence of central nervous system (CNS) involvement by lymphoma * Any laboratory or radiographic tests performed to assess CNS involvement must be negative and must be performed within 42 days prior to registration * Patients may have either measurable or evaluable limited-stage DLBCL * Patients rendered free of measurable or evaluable disease by virtue of biopsy (resection) are also eligible * If patient has measurable disease it must be documented on the Lymphoma Baseline Tumor Assessment Form (Form #15187) * All measurable disease must be assessed within 28 days prior to registration * Patients with non-measurable disease in addition to measurable disease must have all non-measurable disease assessed within 42 days prior to registration * Patients must have a unilateral or bilateral bone marrow biopsy performed within 42 days prior to registration PATIENT CHARACTERISTICS: * Zubrod performance status 0-2 * Absolute neutrophil count (ANC) ≥ 1,000/mm³ * Platelet count ≥ 100,000/mm³ * Total bilirubin ≤ 2 times upper limit of normal (ULN) (unless due to Gilbert syndrome) * Patients must not be pregnant or nursing * Women/men of reproductive potential must have agreed to use an effective contraceptive method during the study period * Patients must not be known to be HIV-positive * No other prior malignancy is allowed except for the following: * Adequately treated basal cell or squamous cell skin cancer * In situ cervical cancer * Adequately treated stage I or II cancer from which the patient is currently in complete remission * Any other cancer from which the patient has been disease-free for 5 years PRIOR CONCURRENT THERAPY: * Patients must not have received prior chemotherapy, radiotherapy, or antibody therapy for lymphoma

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

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator

Study Sites (240)

Providence Cancer Center

Anchorage, Alaska, 99508, United States

Location

Arizona Cancer Center at University of Arizona Health Sciences Center

Tucson, Arizona, 85724-5024, United States

Location

Aurora Presbyterian Hospital

Aurora, Colorado, 80012, United States

Location

Boulder Community Hospital

Boulder, Colorado, 80301-9019, United States

Location

Penrose Cancer Center at Penrose Hospital

Colorado Springs, Colorado, 80933, United States

Location

St. Anthony Central Hospital

Denver, Colorado, 80204, United States

Location

Kaiser Permanente - Denver

Denver, Colorado, 80205, United States

Location

Porter Adventist Hospital

Denver, Colorado, 80210, United States

Location

Presbyterian - St. Luke's Medical Center

Denver, Colorado, 80218, United States

Location

St. Joseph Hospital

Denver, Colorado, 80218, United States

Location

Rose Medical Center

Denver, Colorado, 80220, United States

Location

CCOP - Colorado Cancer Research Program

Denver, Colorado, 80222, United States

Location

Swedish Medical Center

Englewood, Colorado, 80110, United States

Location

St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center

Grand Junction, Colorado, 81502, United States

Location

North Colorado Medical Center

Greeley, Colorado, 80631, United States

Location

Kaiser Permanente - Lafayette

Lafayette, Colorado, 80026, United States

Location

Littleton Adventist Hospital

Littleton, Colorado, 80122, United States

Location

Sky Ridge Medical Center

Lone Tree, Colorado, 80124, United States

Location

Hope Cancer Care Center at Longmont United Hospital

Longmont, Colorado, 80501, United States

Location

McKee Medical Center

Loveland, Colorado, 80539, United States

Location

Parker Adventist Hospital

Parker, Colorado, 80138, United States

Location

St. Mary - Corwin Regional Medical Center

Pueblo, Colorado, 81004, United States

Location

North Suburban Medical Center

Thornton, Colorado, 80229, United States

Location

Exempla Lutheran Medical Center

Wheat Ridge, Colorado, 80033, United States

Location

Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

Hartford, Connecticut, 06105, United States

Location

Yale Cancer Center

New Haven, Connecticut, 06520-8028, United States

Location

Piedmont Hospital

Atlanta, Georgia, 30309, United States

Location

Northside Hospital Cancer Center

Atlanta, Georgia, 30342-1611, United States

Location

Saint Joseph's Hospital of Atlanta

Atlanta, Georgia, 30342-1701, United States

Location

CCOP - Atlanta Regional

Atlanta, Georgia, 30342, United States

Location

WellStar Cobb Hospital

Austell, Georgia, 30106, United States

Location

John B. Amos Cancer Center

Columbus, Georgia, 31904, United States

Location

Charles B. Eberhart Cancer Center at DeKalb Medical Center

Decatur, Georgia, 30033, United States

Location

Piedmont Fayette Hospital

Fayetteville, Georgia, 30214, United States

Location

Gwinnett Medical Center

Lawrenceville, Georgia, 30045, United States

Location

Kennestone Cancer Center at Wellstar Kennestone Hospital

Marietta, Georgia, 30060, United States

Location

Southern Regional Medical Center

Riverdale, Georgia, 30274-2600, United States

Location

Harbin Clinic Cancer Center - Medical Oncology

Rome, Georgia, 30165, United States

Location

Cancer Research Center of Hawaii

Honolulu, Hawaii, 96813, United States

Location

OnCare Hawaii, Incorporated - Lusitana

Honolulu, Hawaii, 96813, United States

Location

Queen's Cancer Institute at Queen's Medical Center

Honolulu, Hawaii, 96813, United States

Location

Straub Clinic and Hospital, Incorporated

Honolulu, Hawaii, 96813, United States

Location

OnCare Hawaii, Incorporated - Kuakini

Honolulu, Hawaii, 96817-3169, United States

Location

Hawaii Medical Center - East

Honolulu, Hawaii, 96817, United States

Location

Kuakini Medical Center

Honolulu, Hawaii, 96817, United States

Location

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826, United States

Location

Castle Medical Center

Kailua, Hawaii, 96734, United States

Location

Kauai Medical Clinic

Lihue, Hawaii, 96766, United States

Location

Kapiolani Medical Center at Pali Momi

‘Aiea, Hawaii, 96701, United States

Location

Oncare Hawaii, Incorporated - Pali Momi

‘Aiea, Hawaii, 96701, United States

Location

Leeward Radiation Oncology

‘Ewa Beach, Hawaii, 96706, United States

Location

Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center

Boise, Idaho, 83706, United States

Location

Mountain States Tumor Institute at St. Luke's Regional Medical Center

Boise, Idaho, 83712, United States

Location

Illinois CancerCare - Bloomington

Bloomington, Illinois, 61701, United States

Location

St. Joseph Medical Center

Bloomington, Illinois, 61701, United States

Location

Graham Hospital

Canton, Illinois, 61520, United States

Location

Illinois CancerCare - Canton

Canton, Illinois, 61520, United States

Location

Illinois CancerCare - Carthage

Carthage, Illinois, 62321, United States

Location

Memorial Hospital

Carthage, Illinois, 62321, United States

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

Hematology and Oncology Associates

Chicago, Illinois, 60611, United States

Location

Eureka Community Hospital

Eureka, Illinois, 61530, United States

Location

Illinois CancerCare - Eureka

Eureka, Illinois, 61530, United States

Location

Galesburg Clinic, PC

Galesburg, Illinois, 61401, United States

Location

Illinois CancerCare - Galesburg

Galesburg, Illinois, 61401, United States

Location

Illinois CancerCare - Havana

Havana, Illinois, 62644, United States

Location

Kellogg Cancer Care Center

Highland Park, Illinois, 60035, United States

Location

Provena St. Mary's Regional Cancer Center - Kankakee

Kankakee, Illinois, 60901, United States

Location

Illinois CancerCare - Kewanee Clinic

Kewanee, Illinois, 61443, United States

Location

North Shore Oncology and Hematology Associates, Limited - Libertyville

Libertyville, Illinois, 60048, United States

Location

Illinois CancerCare - Macomb

Macomb, Illinois, 61455, United States

Location

McDonough District Hospital

Macomb, Illinois, 61455, United States

Location

Illinois CancerCare - Monmouth

Monmouth, Illinois, 61462, United States

Location

OSF Holy Family Medical Center

Monmouth, Illinois, 61462, United States

Location

Cancer Care and Hematology Specialists of Chicagoland - Niles

Niles, Illinois, 60714, United States

Location

BroMenn Regional Medical Center

Normal, Illinois, 61761, United States

Location

Community Cancer Center

Normal, Illinois, 61761, United States

Location

Illinois CancerCare - Community Cancer Center

Normal, Illinois, 61761, United States

Location

Community Hospital of Ottawa

Ottawa, Illinois, 61350, United States

Location

Oncology Hematology Associates of Central Illinois, PC - Ottawa

Ottawa, Illinois, 61350, United States

Location

Cancer Treatment Center at Pekin Hospital

Pekin, Illinois, 61554, United States

Location

Illinois CancerCare - Pekin

Pekin, Illinois, 61603, United States

Location

Proctor Hospital

Peoria, Illinois, 61614, United States

Location

CCOP - Illinois Oncology Research Association

Peoria, Illinois, 61615, United States

Location

Oncology Hematology Associates of Central Illinois, PC - Peoria

Peoria, Illinois, 61615, United States

Location

Methodist Medical Center of Illinois

Peoria, Illinois, 61636, United States

Location

OSF St. Francis Medical Center

Peoria, Illinois, 61637, United States

Location

Illinois CancerCare - Peru

Peru, Illinois, 61354, United States

Location

Illinois Valley Community Hospital

Peru, Illinois, 61354, United States

Location

Illinois CancerCare - Princeton

Princeton, Illinois, 61356, United States

Location

Perry Memorial Hospital

Princeton, Illinois, 61356, United States

Location

Hematology Oncology Associates - Skokie

Skokie, Illinois, 60076, United States

Location

Illinois CancerCare - Spring Valley

Spring Valley, Illinois, 61362, United States

Location

St. Francis Hospital and Health Centers - Beech Grove Campus

Beech Grove, Indiana, 46107, United States

Location

Reid Hospital & Health Care Services

Richmond, Indiana, 47374, United States

Location

Siouxland Hematology-Oncology Associates, LLP

Sioux City, Iowa, 51101, United States

Location

Mercy Medical Center - Sioux City

Sioux City, Iowa, 51102, United States

Location

St. Luke's Regional Medical Center

Sioux City, Iowa, 51104, United States

Location

Cancer Center of Kansas, PA - Chanute

Chanute, Kansas, 66720, United States

Location

Cancer Center of Kansas, PA - Dodge City

Dodge City, Kansas, 67801, United States

Location

Cancer Center of Kansas, PA - El Dorado

El Dorado, Kansas, 67042, United States

Location

Cancer Center of Kansas - Fort Scott

Fort Scott, Kansas, 66701, United States

Location

Cancer Center of Kansas-Independence

Independence, Kansas, 67301, United States

Location

Cancer Center of Kansas, PA - Kingman

Kingman, Kansas, 67068, United States

Location

Lawrence Memorial Hospital

Lawrence, Kansas, 66044, United States

Location

Cancer Center of Kansas, PA - Liberal

Liberal, Kansas, 67901, United States

Location

Cancer Center of Kansas, PA - McPherson

McPherson, Kansas, 67460, United States

Location

Cancer Center of Kansas, PA - Newton

Newton, Kansas, 67114, United States

Location

Menorah Medical Center

Overland Park, Kansas, 66209, United States

Location

Saint Luke's Hospital - South

Overland Park, Kansas, 66213, United States

Location

Cancer Center of Kansas, PA - Parsons

Parsons, Kansas, 67357, United States

Location

CCOP - Kansas City

Prairie Village, Kansas, 66208, United States

Location

Cancer Center of Kansas, PA - Pratt

Pratt, Kansas, 67124, United States

Location

Cancer Center of Kansas, PA - Salina

Salina, Kansas, 67401, United States

Location

Cancer Center of Kansas, PA - Wellington

Wellington, Kansas, 67152, United States

Location

Associates in Womens Health, PA - North Review

Wichita, Kansas, 67208, United States

Location

Cancer Center of Kansas, PA - Medical Arts Tower

Wichita, Kansas, 67208, United States

Location

Cancer Center of Kansas, PA - Wichita

Wichita, Kansas, 67214, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214, United States

Location

Via Christi Cancer Center at Via Christi Regional Medical Center

Wichita, Kansas, 67214, United States

Location

Cancer Center of Kansas, PA - Winfield

Winfield, Kansas, 67156, United States

Location

Lucille P. Markey Cancer Center at University of Kentucky

Lexington, Kentucky, 40536-0093, United States

Location

Saint Joseph Mercy Cancer Center

Ann Arbor, Michigan, 48106-0995, United States

Location

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, 48106, United States

Location

Oakwood Cancer Center at Oakwood Hospital and Medical Center

Dearborn, Michigan, 48123-2500, United States

Location

Josephine Ford Cancer Center at Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Genesys Hurley Cancer Institute

Flint, Michigan, 48503, United States

Location

Hurley Medical Center

Flint, Michigan, 48503, United States

Location

Genesys Regional Medical Center

Grand Blanc, Michigan, 48439, United States

Location

Van Elslander Cancer Center at St. John Hospital and Medical Center

Grosse Pointe Woods, Michigan, 48236, United States

Location

Foote Memorial Hospital

Jackson, Michigan, 49201, United States

Location

Borgess Medical Center

Kalamazoo, Michigan, 49001, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007-3731, United States

Location

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007, United States

Location

Sparrow Regional Cancer Center

Lansing, Michigan, 48912-1811, United States

Location

St. Mary Mercy Hospital

Livonia, Michigan, 48154, United States

Location

St. Joseph Mercy Oakland

Pontiac, Michigan, 48341-2985, United States

Location

Mercy Regional Cancer Center at Mercy Hospital

Port Huron, Michigan, 48060, United States

Location

Seton Cancer Institute at Saint Mary's - Saginaw

Saginaw, Michigan, 48601, United States

Location

St. John Macomb Hospital

Warren, Michigan, 48093, United States

Location

Fairview Ridges Hospital

Burnsville, Minnesota, 55337, United States

Location

Mercy and Unity Cancer Center at Mercy Hospital

Coon Rapids, Minnesota, 55433, United States

Location

Duluth Clinic Cancer Center - Duluth

Duluth, Minnesota, 55805-1983, United States

Location

CCOP - Duluth

Duluth, Minnesota, 55805, United States

Location

Miller - Dwan Medical Center

Duluth, Minnesota, 55805, United States

Location

Fairview Southdale Hospital

Edina, Minnesota, 55435, United States

Location

Mercy and Unity Cancer Center at Unity Hospital

Fridley, Minnesota, 55432, United States

Location

Hutchinson Area Health Care

Hutchinson, Minnesota, 55350, United States

Location

HealthEast Cancer Care at St. John's Hospital

Maplewood, Minnesota, 55109, United States

Location

Minnesota Oncology - Maplewood

Maplewood, Minnesota, 55109, United States

Location

Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Hennepin County Medical Center - Minneapolis

Minneapolis, Minnesota, 55415, United States

Location

New Ulm Medical Center

New Ulm, Minnesota, 56073, United States

Location

Humphrey Cancer Center at North Memorial Outpatient Center

Robbinsdale, Minnesota, 55422-2900, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

Park Nicollet Cancer Center

Saint Louis Park, Minnesota, 55416, United States

Location

Regions Hospital Cancer Care Center

Saint Paul, Minnesota, 55101, United States

Location

United Hospital

Saint Paul, Minnesota, 55102, United States

Location

St. Francis Cancer Center at St. Francis Medical Center

Shakopee, Minnesota, 55379, United States

Location

Lakeview Hospital

Stillwater, Minnesota, 55082, United States

Location

Ridgeview Medical Center

Waconia, Minnesota, 55387, United States

Location

Willmar Cancer Center at Rice Memorial Hospital

Willmar, Minnesota, 56201, United States

Location

Minnesota Oncology - Woodbury

Woodbury, Minnesota, 55125, United States

Location

Saint Luke's Cancer Institute at Saint Luke's Hospital

Kansas City, Missouri, 64111, United States

Location

North Kansas City Hospital

Kansas City, Missouri, 64116, United States

Location

Heartland Hematology Oncology Associates, Incorporated

Kansas City, Missouri, 64118, United States

Location

Research Medical Center

Kansas City, Missouri, 64132, United States

Location

Saint Luke's East - Lee's Summit

Lee's Summit, Missouri, 64086, United States

Location

Parvin Radiation Oncology

Liberty, Missouri, 64068, United States

Location

Heartland Regional Medical Center

Saint Joseph, Missouri, 64506, United States

Location

Saint Joseph Oncology, Incorporated

Saint Joseph, Missouri, 64507, United States

Location

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, 63110, United States

Location

CCOP - Montana Cancer Consortium

Billings, Montana, 59101, United States

Location

St. Vincent Healthcare Cancer Care Services

Billings, Montana, 59101, United States

Location

Hematology-Oncology Centers of the Northern Rockies - Billings

Billings, Montana, 59102, United States

Location

Billings Clinic - Downtown

Billings, Montana, 59107-7000, United States

Location

Bozeman Deaconess Cancer Center

Bozeman, Montana, 59715, United States

Location

St. James Healthcare Cancer Care

Butte, Montana, 59701, United States

Location

Great Falls Clinic - Main Facility

Great Falls, Montana, 59405, United States

Location

Sletten Cancer Institute at Benefis Healthcare

Great Falls, Montana, 59405, United States

Location

St. Peter's Hospital

Helena, Montana, 59601, United States

Location

Glacier Oncology, PLLC

Kalispell, Montana, 59901, United States

Location

Kalispell Medical Oncology at KRMC

Kalispell, Montana, 59901, United States

Location

Kalispell Regional Medical Center

Kalispell, Montana, 59901, United States

Location

Montana Cancer Specialists at Montana Cancer Center

Missoula, Montana, 59807-7877, United States

Location

Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

Missoula, Montana, 59807, United States

Location

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

Rochester, New York, 14642, United States

Location

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, 27534, United States

Location

Rex Cancer Center at Rex Hospital

Raleigh, North Carolina, 27607, United States

Location

Iredell Memorial Hospital

Statesville, North Carolina, 28677, United States

Location

MeritCare Broadway

Fargo, North Dakota, 58102, United States

Location

CCOP - MeritCare Hospital

Fargo, North Dakota, 58122, United States

Location

Roger Maris Cancer Center at MeritCare Hospital

Fargo, North Dakota, 58122, United States

Location

Grandview Hospital

Dayton, Ohio, 45405, United States

Location

Good Samaritan Hospital

Dayton, Ohio, 45406, United States

Location

David L. Rike Cancer Center at Miami Valley Hospital

Dayton, Ohio, 45409, United States

Location

Samaritan North Cancer Care Center

Dayton, Ohio, 45415, United States

Location

CCOP - Dayton

Dayton, Ohio, 45420, United States

Location

Blanchard Valley Medical Associates

Findlay, Ohio, 45840, United States

Location

Middletown Regional Hospital

Franklin, Ohio, 45005-1066, United States

Location

Wayne Hospital

Greenville, Ohio, 45331, United States

Location

Charles F. Kettering Memorial Hospital

Kettering, Ohio, 45429, United States

Location

UVMC Cancer Care Center at Upper Valley Medical Center

Troy, Ohio, 45373-1300, United States

Location

Ruth G. McMillan Cancer Center at Greene Memorial Hospital

Xenia, Ohio, 45385, United States

Location

Natalie Warren Bryant Cancer Center at St. Francis Hospital

Tulsa, Oklahoma, 74136, United States

Location

Geisinger Cancer Institute at Geisinger Health

Danville, Pennsylvania, 17822-0001, United States

Location

Cancer Centers of the Carolinas - Faris Road

Greenville, South Carolina, 29605, United States

Location

Cancer Centers of the Carolinas - Grove Commons

Greenville, South Carolina, 29605, United States

Location

Greenville Hospital Cancer Center

Greenville, South Carolina, 29605, United States

Location

CCOP - Greenville

Greenville, South Carolina, 29615, United States

Location

Cancer Centers of the Carolinas - Greer Medical Oncology

Greer, South Carolina, 29650, United States

Location

Cancer Centers of the Carolinas - Seneca

Seneca, South Carolina, 29672, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Cancer Centers of the Carolinas - Spartanburg

Spartanburg, South Carolina, 29307, United States

Location

Sanford Cancer Center at Sanford USD Medical Center

Sioux Falls, South Dakota, 57117-5039, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229-3900, United States

Location

Cancer Therapy and Research Center

San Antonio, Texas, 78229, United States

Location

University Hospital - San Antonio

San Antonio, Texas, 78229, United States

Location

Island Hospital Cancer Care Center at Island Hospital

Anacortes, Washington, 98221, United States

Location

St. Joseph Cancer Center

Bellingham, Washington, 98225, United States

Location

Olympic Hematology and Oncology

Bremerton, Washington, 98310, United States

Location

Highline Medical Center Cancer Center

Burien, Washington, 98166, United States

Location

Columbia Basin Hematology

Kennewick, Washington, 99336, United States

Location

Skagit Valley Hospital Cancer Care Center

Mount Vernon, Washington, 98274, United States

Location

Harrison Poulsbo Hematology and Onocology

Poulsbo, Washington, 98370, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Minor and James Medical, PLLC

Seattle, Washington, 98104, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Group Health Central Hospital

Seattle, Washington, 98112, United States

Location

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

Seattle, Washington, 98122-4307, United States

Location

Polyclinic First Hill

Seattle, Washington, 98122, United States

Location

University Cancer Center at University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

North Puget Oncology at United General Hospital

Sedro-Woolley, Washington, 98284, United States

Location

Cancer Care Northwest - Spokane South

Spokane, Washington, 99202, United States

Location

Evergreen Hematology and Oncology, PS

Spokane, Washington, 99218, United States

Location

Wenatchee Valley Medical Center

Wenatchee, Washington, 98801-2028, United States

Location

Mary Babb Randolph Cancer Center at West Virginia University Hospitals

Morgantown, West Virginia, 26506, United States

Location

Gundersen Lutheran Center for Cancer and Blood

La Crosse, Wisconsin, 54601, United States

Location

Rocky Mountain Oncology

Casper, Wyoming, 82609, United States

Location

MeSH Terms

Conditions

Lymphoma; Lymphoma, Large B-Cell, Diffuse

Interventions

Rituximab; Cyclophosphamide; Doxorubicin; Prednisone; Vincristine; Fluorodeoxyglucose F18; Serotonin Plasma Membrane Transport Proteins; ibritumomab tiuxetan

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Deoxyglucose; Deoxy Sugars; Symporters; Ion Pumps; Membrane Transport Proteins; Carrier Proteins; Plasma Membrane Neurotransmitter Transport Proteins; Neurotransmitter Transport Proteins; Solute Carrier Proteins; Membrane Proteins

Results Point of Contact

• Title: Lymphoma Committee Statistician
• Organization: SWOG Statistics and Data Management Center

lymph@crab.org

206-667-4623

Study Officials

• Daniel O. Persky, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2011
• First Posted: May 25, 2011
• Study Start: September 1, 2011
• Primary Completion: June 3, 2020
• Study Completion: December 1, 2023
• Last Updated: June 17, 2025
• Results First Posted: June 30, 2021

Record last verified: 2025-05

Locations

US (240)