Bendamustine Hydrochloride and Rituximab With or Without Bortezomib Followed by Rituximab With or Without Lenalidomide in Treating Patients With High-Risk Stage II, Stage III, or Stage IV Follicular Lymphoma
Conditions
Lymphoma
Conditions: official terms
Lymphoma - Lymphoma, Follicular
Conditions: Keywords
contiguous stage II grade 1 follicular lymphoma, contiguous stage II grade 2 follicular lymphoma, contiguous stage II grade 3 follicular lymphoma, noncontiguous stage II grade 1 follicular lymphoma, noncontiguous stage II grade 2 follicular lymphoma, noncontiguous stage II grade 3 follicular lymphoma, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: rituximab Type: Biological
Name: bendamustine hydrochloride Type: Drug
Name: bortezomib Type: Drug
Name: lenalidomide Type: Drug
Overall Status
Recruiting
Summary
RATIONALE: Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. 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. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. It is not yet known whether giving bendamustine hydrochloride and rituximab together alone is more effective than giving bendamustine hydrochloride and rituximab together with bortezomib or lenalidomide in treating follicular lymphoma.

PURPOSE: This randomized phase II trial is studying giving bendamustine hydrochloride and rituximab together with or without bortezomib followed by rituximab with or without lenalidomide to see how well they work in treating patients with high-risk stage II, stage III, or stage IV follicular lymphoma.
Detailed Description
OBJECTIVES:

Primary

- To compare the complete remission rate in patients with high-risk follicular lymphoma receiving induction therapy comprising bendamustine hydrochloride and rituximab with vs without bortezomib.

- To compare the 1-year post-induction disease-free survival rate in patients receiving continuation therapy comprising rituximab with vs without lenalidomide.

Secondary

- To determine the 3-year progression-free survival and the 5-year overall survival of these patients.

- To evaluate patient-reported outcomes at baseline and during treatment to determine differences in symptom palliation, treatment-related symptoms, and overall health-related quality of life.

- To examine the association between baseline FLIPI information and outcome of these patients.

- To examine the association between baseline and end-of-treatment patient comorbidities assessed by the Cumulative Illness Rating Scale (CIRS) and outcome.

- To create an image and tissue bank including serial PET/CT scans, diagnostic paraffin-embedded tissue, germline DNA, and serial blood and bone marrow samples sufficient to support proposed and future studies of tumor and host characteristics that may predict for clinical outcome, including treatment arm effects, and enhance existing prognostic indices. (exploratory)

OUTLINE: Patients are stratified according to FLIPI-1score (1 or 2 vs 3 vs 4 or 5) and GELF tumor burden (low vs high). Patients are randomized to 1 of 3 treatment arms.

- Arm I: Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Beginning 4 weeks after the completion of induction therapy, patients receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.

- Arm II: Patients receive rituximab IV on day 1; bortezomib IV on days 1, 4, 8, and 11; and bendamustine hydrochloride IV over 1 hour on days 1 and 4. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Beginning 4 weeks after the completion of induction therapy, patients receive rituximab as in arm I.

- Arm III: Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Immediately after completing induction therapy, patients receive oral lenalidomide on days 1-21. Treatment repeats every 4 weeks for 13 courses in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the completion of induction therapy, patients receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.

Quality of life (including fatigue, neurotoxicity, anxiety, and depression) is assessed by questionnaire at baseline and periodically during study therapy.

Blood, bone marrow, and tissue samples may be collected periodically for correlative studies and for a repository.

After completion of study therapy, patients are followed up periodically for 15 years.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: DISEASE CHARACTERISTICS:

- Histologically confirmed (biopsy-proven) diagnosis of follicular B-cell non-Hodgkin lymphoma with no evidence of transformation to large cell histology

- Patients having both diffuse and follicular architectural elements are eligible if the histology is predominantly follicular (i.e., ≥ 50% of the cross-sectional area) and there is no evidence of transformation to a large cell histology

- Diagnostic confirmation (i.e., core needle or excisional lymph node biopsy) required if the interval since tissue diagnosis of low-grade malignant lymphoma is > 24 months

- Bone marrow biopsy alone not acceptable

- Stage II, III, or IV AND grade 1, 2, or 3a disease

- Must meet criteria for High Tumor Burden (higher risk) as defined by either the Groupe D'Etude des Lymphomes Follicularies (GELF) criteria OR the follicular lymphoma international prognostic index (FLIPI) as defined below:

- Patient must meet ≥ 1 of the following GELF criteria:

- Nodal or extranodal mass ≥ 7 cm

- At least 3 nodal masses > 3.0 cm in diameter

- Systemic symptoms due to lymphoma or B symptoms

- Splenomegaly with spleen > 16 cm by CT scan

- Evidence of compression syndrome (e.g., ureteral, orbital, gastrointestinal) or pleural or peritoneal serous effusion due to lymphoma (irrespective of cell content)

- Leukemic presentation (≥ 5.0 x 10^9/L malignant circulating follicular cells)

- Cytopenias (polymorphonuclear leukocytes < 1.0 X 10^9/L, hemoglobin < 10 g/dL, and/or platelets < 100 x 10^9/L)

- Patient must have a FLIPI-1 score of 3, 4, or 5 (1 point per criterion below):

- Age ≥ 60 years

- Stage III-IV disease

- Hemoglobin level < 12 g/dL

- > 4 nodal areas

- Serum LDH level above normal

- At least 1 objective measurable disease parameter

- Baseline measurements and evaluations (PET and CT) obtained within 6 weeks of randomization

- Measurable disease in the liver is required if the liver is the only site of lymphoma

PATIENT CHARACTERISTICS:

- See Disease Characteristics

- ECOG performance status 0-2

- ANC ≥ 1,500/mm³ (includes neutrophils and bands)

- Platelet count ≥ 100,000/mm³

- Creatinine ≤ 2.0 mg/dL

- AST and ALT ≤ 5 x upper limit of normal (ULN)

- Alkaline phosphatase ≤ 5 x ULN

- Total bilirubin ≤ 1.5 x ULN (patients with known Gilbert disease should contact the study PI)

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use 2 effective methods (1 highly effective and 1 additional effective method) of contraception ≥ 28 days before, during, and for ≥ 28 days after completing study treatment

- HIV-positive patients must meet all of the following criteria:

- HIV is sensitive to antiretroviral therapy

- Must be willing to take effective antiretroviral therapy if indicated

- No history of CD4 < 300 cells/mm³ prior to or at the time of lymphoma diagnosis

- No history of AIDS-defining conditions

- If on antiretroviral therapy, must not be taking zidovudine or stavudine

- Must be willing to take prophylaxis for Pneumocystis jiroveci pneumonia (PCP) during therapy and ≥ 2 months following completion of study therapy or until the CD4 cells recover to over 250 cells/mm³

- No recent history of malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for ≥ 2 years

- No active, uncontrolled infections (afebrile for > 48 hours off antibiotics)

- No ≥ grade 2 neuropathy

- No myocardial infarction within the past 6 months

- No NYHA class III-IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities

- No serious medical or psychiatric illness likely to interfere with participation in this clinical study

- No known hypersensitivity to boron or mannitol

- No chronic carriers of hepatitis B virus (HBV) with positive hepatitis surface antigen (HBsAg +)

- Patients with a prior history of HBV infection, but immune, with only IgG hepatitis core antibody positive (HBcAb+), must receive antiviral prophylaxis (e.g., lamivudine 100 mg po daily) for ≥ 1 week prior to course 1 and throughout induction and continuation therapy and for ≥ 12 months after the last rituximab dose

- Must register into the mandatory RevAssist® program and be willing and able to comply with the requirements of RevAssist® (for patients randomized to arm III)

PRIOR CONCURRENT THERAPY:

- No prior chemotherapy, radiotherapy, or immunotherapy for lymphoma

- Prednisone or other corticosteroids used for non-lymphomatous conditions will not be considered as prior chemotherapy

- A prior/recent short course (< 2 weeks) of steroids for symptom relief of lymphoma-related symptoms is allowed
Locations
Marin Cancer Care Inc
Greenbrae, California, United States
Status: Recruiting
Contact: Peter D. Eisenberg - 415-925-5000 - info@marinspecialtycare.com
Salinas Valley Memorial
Salinas, California, United States
Status: Recruiting
Contact: Geetha N. Varma - 831-759-1838 - tnielsen2@svmh.com
Stanford University Hospitals and Clinics
Stanford, California, United States
Status: Recruiting
Contact: Ranjana H. Advani - 650-498-7061 - clinicaltrials@med.stanford.edu
The Medical Center of Aurora
Aurora, Colorado, United States
Status: Recruiting
Contact: Keren Sturtz - 888-785-6789
Boulder Community Hospital
Boulder, Colorado, United States
Status: Recruiting
Contact: Keren Sturtz - 888-785-6789
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, United States
Status: Recruiting
Contact: Keren Sturtz - 888-785-6789
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States
Status: Recruiting
Contact: Keren Sturtz - 888-785-6789
Colorado Blood Cancer Institute
Denver, Colorado, United States
Status: Recruiting
Contact: Keren Sturtz - 888-785-6789
Colorado Cancer Research Program CCOP
Denver, Colorado, United States
Status: Recruiting
Contact: Keren Sturtz - 888-785-6789
Exempla Saint Joseph Hospital
Denver, Colorado, United States
Status: Recruiting
Contact: Keren Sturtz - 888-785-6789
Porter Adventist Hospital
Denver, Colorado, United States
Status: Recruiting
Contact: Keren Sturtz - 888-785-6789
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, United States
Status: Recruiting
Contact: Keren Sturtz - 888-785-6789
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado, United States
Status: Recruiting
Contact: Keren Sturtz - 888-785-6789
Rocky Mountain Cancer Centers-Rose
Denver, Colorado, United States
Status: Recruiting
Contact: Keren Sturtz - 888-785-6789
Rose Medical Center
Denver, Colorado, United States
Status: Recruiting
Contact: Keren Sturtz - 888-785-6789
Comprehensive Cancer Care and Research Institute of Colorado LLC
Englewood, Colorado, United States
Status: Recruiting
Contact: Keren Sturtz - 888-785-6789
Swedish Medical Center
Englewood, Colorado, United States
Status: Recruiting
Contact: Keren Sturtz - 888-785-6789
Poudre Valley Hospital
Fort Collins, Colorado, United States
Status: Recruiting
Contact: Regina J. Brown - 970-297-6150
Mountain Blue Cancer Care Center
Golden, Colorado, United States
Status: Recruiting
Contact: Keren Sturtz - 888-785-6789
North Colorado Medical Center
Greeley, Colorado, United States
Status: Recruiting
Contact: Keren Sturtz - 888-785-6789
Rocky Mountain Cancer Centers-Greenwood Village
Greenwood Village, Colorado, United States
Status: Recruiting
Contact: Keren Sturtz - 888-785-6789
Rocky Mountain Cancer Centers-Lakewood
Lakewood, Colorado, United States
Status: Recruiting
Contact: Keren Sturtz - 888-785-6789
Saint Anthony Hospital
Lakewood, Colorado, United States
Status: Recruiting
Contact: Keren Sturtz - 888-785-6789
Littleton Adventist Hospital
Littleton, Colorado, United States
Status: Recruiting
Contact: Keren Sturtz - 888-785-6789
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado, United States
Status: Recruiting
Contact: Keren Sturtz - 888-785-6789
Sky Ridge Medical Center
Lone Tree, Colorado, United States
Status: Recruiting
Contact: Keren Sturtz - 888-785-6789
Longmont United Hospital
Longmont, Colorado, United States
Status: Recruiting
Contact: Keren Sturtz - 888-785-6789
McKee Medical Center
Loveland, Colorado, United States
Status: Recruiting
Contact: Keren Sturtz - 888-785-6789
Parker Adventist Hospital
Parker, Colorado, United States
Status: Recruiting
Contact: Keren Sturtz - 888-785-6789
Rocky Mountain Cancer Centers-Parker
Parker, Colorado, United States
Status: Recruiting
Contact: Keren Sturtz - 888-785-6789
Saint Mary Corwin Medical Center
Pueblo, Colorado, United States
Status: Recruiting
Contact: Keren Sturtz - 888-785-6789
North Suburban Medical Center
Thornton, Colorado, United States
Status: Terminated
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, United States
Status: Recruiting
Contact: Keren Sturtz - 888-785-6789
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States
Status: Recruiting
Contact: Gregory A. Masters - 302-733-6227
Emory University/Winship Cancer Institute
Atlanta, Georgia, United States
Status: Recruiting
Contact: Christopher R. Flowers - 404-778-1868
Georgia Regents University Medical Center
Augusta, Georgia, United States
Status: Recruiting
Contact: Sharad A. Ghamande - 706-721-1663 - cancer@georgiahealth.edu
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States
Status: Recruiting
Contact: Christopher M. Reynolds - 734-712-4673
Rush - Copley Medical Center
Aurora, Illinois, United States
Status: Recruiting
Contact: Ronnie F. Luyun - 800-446-5532
Illinois CancerCare-Bloomington
Bloomington, Illinois, United States
Status: Recruiting
Contact: Nguyet A. Le-Lindqwister - 800-793-2262
Saint Joseph Medical Center
Bloomington, Illinois, United States
Status: Recruiting
Contact: Nguyet A. Le-Lindqwister - 800-793-2262
Graham Hospital Association
Canton, Illinois, United States
Status: Terminated
Illinois CancerCare-Canton
Canton, Illinois, United States
Status: Recruiting
Contact: Nguyet A. Le-Lindqwister - 800-793-2262
Illinois CancerCare-Carthage
Carthage, Illinois, United States
Status: Recruiting
Contact: Nguyet A. Le-Lindqwister - 800-793-2262
Memorial Hospital
Carthage, Illinois, United States
Status: Terminated
Centralia Oncology Clinic
Centralia, Illinois, United States
Status: Active, not recruiting
Northwestern University
Chicago, Illinois, United States
Status: Recruiting
Contact: Jane N. Winter - 312-695-1301 - cancer@northwestern.edu
Rush University Medical Center
Chicago, Illinois, United States
Status: Terminated
Carle on Vermilion
Danville, Illinois, United States
Status: Recruiting
Contact: Ronnie F. Luyun - 800-446-5532
Cancer Care Center of Decatur
Decatur, Illinois, United States
Status: Active, not recruiting
Decatur Memorial Hospital
Decatur, Illinois, United States
Status: Active, not recruiting
Carle Physician Group-Effingham
Effingham, Illinois, United States
Status: Recruiting
Contact: Ronnie F. Luyun - 800-446-5532
Crossroads Cancer Center
Effingham, Illinois, United States
Status: Active, not recruiting
Eureka Hospital
Eureka, Illinois, United States
Status: Active, not recruiting
Illinois CancerCare-Eureka
Eureka, Illinois, United States
Status: Recruiting
Contact: Nguyet A. Le-Lindqwister - 800-793-2262
Illinois CancerCare Galesburg
Galesburg, Illinois, United States
Status: Recruiting
Contact: Nguyet A. Le-Lindqwister - 800-793-2262
Mason District Hospital
Havana, Illinois, United States
Status: Terminated
Hinsdale Hematology Oncology Associates Incorporated
Hinsdale, Illinois, United States
Status: Recruiting
Contact: Elyse C. Schneiderman - 630-654-1790 - info@hhoaltd.com
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, United States
Status: Recruiting
Contact: Nguyet A. Le-Lindqwister - 800-793-2262
North Shore Hematology Oncology
Libertyville, Illinois, United States
Status: Recruiting
Contact: Jane N. Winter - 312-695-1301 - cancer@northwestern.edu
Illinois CancerCare-Macomb
Macomb, Illinois, United States
Status: Recruiting
Contact: Nguyet A. Le-Lindqwister - 800-793-2262
Mcdonough District Hospital
Macomb, Illinois, United States
Status: Terminated
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States
Status: Recruiting
Contact: Ronnie F. Luyun - 800-446-5532
Illinois CancerCare-Monmouth
Monmouth, Illinois, United States
Status: Terminated
Illinois Cancer Specialists-Niles
Niles, Illinois, United States
Status: Recruiting
Contact: Jane N. Winter - 312-695-1301 - cancer@northwestern.edu
Bromenn Regional Medical Center
Normal, Illinois, United States
Status: Terminated
Community Cancer Center Foundation
Normal, Illinois, United States
Status: Terminated
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States
Status: Recruiting
Contact: Nguyet A. Le-Lindqwister - 800-793-2262
Ottawa Regional Hospital and Healthcare Center
Ottawa, Illinois, United States
Status: Active, not recruiting
Illinois CancerCare-Pekin
Pekin, Illinois, United States
Status: Recruiting
Contact: Nguyet A. Le-Lindqwister - 800-793-2262
Pekin Cancer Treatment Center
Pekin, Illinois, United States
Status: Recruiting
Contact: Nguyet A. Le-Lindqwister - 800-793-2262
Illinois CancerCare-Peoria
Peoria, Illinois, United States
Status: Recruiting
Contact: Nguyet A. Le-Lindqwister - 800-793-2262
Illinois Oncology Research Association CCOP
Peoria, Illinois, United States
Status: Terminated
Methodist Medical Center of Illinois
Peoria, Illinois, United States
Status: Recruiting
Contact: Nguyet A. Le-Lindqwister - 800-793-2262
OSF Saint Francis Medical Center
Peoria, Illinois, United States
Status: Recruiting
Contact: Nguyet A. Le-Lindqwister - 800-793-2262
Proctor Hospital
Peoria, Illinois, United States
Status: Terminated
Illinois CancerCare-Peru
Peru, Illinois, United States
Status: Recruiting
Contact: Nguyet A. Le-Lindqwister - 800-793-2262
Illinois Valley Hospital
Peru, Illinois, United States
Status: Terminated
Illinois CancerCare-Princeton
Princeton, Illinois, United States
Status: Recruiting
Contact: Nguyet A. Le-Lindqwister - 800-793-2262
Perry Memorial Hospital
Princeton, Illinois, United States
Status: Terminated
Swedish American Hospital
Rockford, Illinois, United States
Status: Withdrawn
SwedishAmerican Regional Cancer Center/ACT
Rockford, Illinois, United States
Status: Recruiting
Contact: Harvey E. Einhorn - 779-696-9400 - cancercare@swedishamerican.org
Memorial Medical Center
Springfield, Illinois, United States
Status: Recruiting
Contact: James L. Wade - 217-876-4740 - kcheek@dmhhs.org
Carle Cancer Center
Urbana, Illinois, United States
Status: Recruiting
Contact: Ronnie F. Luyun - 800-446-5532
The Carle Foundation Hospital
Urbana, Illinois, United States
Status: Recruiting
Contact: Ronnie F. Luyun - 800-446-5532
Horizon Oncology Center
Lafayette, Indiana, United States
Status: Withdrawn
IU Health Arnett Cancer Care
Lafayette, Indiana, United States
Status: Active, not recruiting
Franciscan Saint Anthony Health-Michigan City
Michigan City, Indiana, United States
Status: Recruiting
Contact: Ronnie F. Luyun - 800-446-5532
McFarland Clinic PC-William R Bliss Cancer Center
Ames, Iowa, United States
Status: Recruiting
Contact: Joseph J. Merchant - 515-239-2621
Ottumwa Regional Health Center
Ottumwa, Iowa, United States
Status: Active, not recruiting
Mercy Medical Center-Sioux City
Sioux City, Iowa, United States
Status: Terminated
Saint Luke's Regional Medical Center
Sioux City, Iowa, United States
Status: Terminated
Siouxland Hematology Oncology Associates
Sioux City, Iowa, United States
Status: Recruiting
Contact: Donald B. Wender - 712-252-0088
Lawrence Memorial Hospital
Lawrence, Kansas, United States
Status: Recruiting
Contact: Shaker R. Dakhil - 316-262-4467
Wesley Medical Center
Wichita, Kansas, United States
Status: Recruiting
Contact: Shaker R. Dakhil - 316-262-4467
Ochsner Health Center-Summa
Baton Rouge, Louisiana, United States
Status: Recruiting
Contact: Robert V. Emmons - 888-562-4763
Ochsner Baptist Medical Center
New Orleans, Louisiana, United States
Status: Recruiting
Contact: Robert V. Emmons - 888-562-4763
Ochsner Medical Center Jefferson
New Orleans, Louisiana, United States
Status: Recruiting
Contact: Robert V. Emmons - 888-562-4763
Greater Baltimore Medical Center
Baltimore, Maryland, United States
Status: Recruiting
Contact: Marshall A. Levine - 443-849-3706
Dana-Farber Harvard Cancer Center
Boston, Massachusetts, United States
Status: Recruiting
Contact: Jon E. Arnason - jarnason@bidmc.harvard.edu
Tufts Medical Center
Boston, Massachusetts, United States
Status: Recruiting
Contact: Andrew M. Evens - 617-636-5000 - ContactUsCancerCenter@TuftsMedicalCenter.org
University of Massachusetts Medical School
Worcester, Massachusetts, United States
Status: Recruiting
Contact: Alan G. Rosmarin - 508-856-3216 - cancer.research@umassmed.edu
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States
Status: Recruiting
Contact: Christopher M. Reynolds - 734-712-4673
Saint John Hospital and Medical Center
Detroit, Michigan, United States
Status: Recruiting
Contact: Christopher M. Reynolds - 734-712-4673
Green Bay Oncology - Escanaba
Escanaba, Michigan, United States
Status: Recruiting
Contact: Brian L. Burnette - 800-432-6049
Green Bay Oncology - Iron Mountain
Iron Mountain, Michigan, United States
Status: Recruiting
Contact: Brian L. Burnette - 800-432-6049
Allegiance Health
Jackson, Michigan, United States
Status: Recruiting
Contact: Christopher M. Reynolds - 734-712-4673
Borgess Medical Center
Kalamazoo, Michigan, United States
Status: Recruiting
Contact: Sunil Nagpal - 269-373-7458
Bronson Methodist Hospital
Kalamazoo, Michigan, United States
Status: Recruiting
Contact: Sunil Nagpal - 269-373-7458
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Status: Recruiting
Contact: Sunil Nagpal - 269-373-7458
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States
Status: Recruiting
Contact: Christopher M. Reynolds - 734-712-4673
Saint Mary's of Michigan
Saginaw, Michigan, United States
Status: Recruiting
Contact: Christopher M. Reynolds - 734-712-4673
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States
Status: Recruiting
Contact: Christopher M. Reynolds - 734-712-4673
Sanford Clinic North-Bemidgi
Bemidji, Minnesota, United States
Status: Recruiting
Contact: Preston D. Steen - 701-234-6161
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, United States
Status: Recruiting
Contact: Bret E. Friday - 888-203-7267
Fairview Ridges Hospital
Burnsville, Minnesota, United States
Status: Recruiting
Contact: Joseph W. Leach - 952-993-1517 - MMCCOP@parknicollet.com
Mercy Hospital
Coon Rapids, Minnesota, United States
Status: Recruiting
Contact: Joseph W. Leach - 952-993-1517 - MMCCOP@parknicollet.com
Essentia Health Cancer Center
Duluth, Minnesota, United States
Status: Recruiting
Contact: Bret E. Friday - 888-203-7267
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, United States
Status: Recruiting
Contact: Bret E. Friday - 888-203-7267
Miller-Dwan Hospital
Duluth, Minnesota, United States
Status: Recruiting
Contact: Bret E. Friday - 888-203-7267
Fairview-Southdale Hospital
Edina, Minnesota, United States
Status: Recruiting
Contact: Joseph W. Leach - 952-993-1517 - MMCCOP@parknicollet.com
Unity Hospital
Fridley, Minnesota, United States
Status: Recruiting
Contact: Joseph W. Leach - 952-993-1517 - MMCCOP@parknicollet.com
Hutchinson Area Health Care
Hutchinson, Minnesota, United States
Status: Recruiting
Contact: Joseph W. Leach - 952-993-1517 - MMCCOP@parknicollet.com
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, United States
Status: Recruiting
Contact: Joseph W. Leach - 952-993-1517 - MMCCOP@parknicollet.com
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States
Status: Recruiting
Contact: Joseph W. Leach - 952-993-1517 - MMCCOP@parknicollet.com
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States
Status: Recruiting
Contact: Joseph W. Leach - 952-993-1517 - MMCCOP@parknicollet.com
Hennepin County Medical Center
Minneapolis, Minnesota, United States
Status: Recruiting
Contact: Joseph W. Leach - 952-993-1517 - MMCCOP@parknicollet.com
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States
Status: Recruiting
Contact: Joseph W. Leach - 952-993-1517 - MMCCOP@parknicollet.com
Mayo Clinic
Rochester, Minnesota, United States
Status: Recruiting
Contact: Thomas M. Habermann - 507-538-7623
Metro-Minnesota CCOP
Saint Louis Park, Minnesota, United States
Status: Terminated
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States
Status: Recruiting
Contact: Joseph W. Leach - 952-993-1517 - MMCCOP@parknicollet.com
Regions Hospital
Saint Paul, Minnesota, United States
Status: Recruiting
Contact: Joseph W. Leach - 952-993-1517 - MMCCOP@parknicollet.com
United Hospital
Saint Paul, Minnesota, United States
Status: Recruiting
Contact: Joseph W. Leach - 952-993-1517 - MMCCOP@parknicollet.com
Saint Francis Regional Medical Center
Shakopee, Minnesota, United States
Status: Recruiting
Contact: Joseph W. Leach - 952-993-1517 - MMCCOP@parknicollet.com
Lakeview Hospital
Stillwater, Minnesota, United States
Status: Active, not recruiting
Ridgeview Medical Center
Waconia, Minnesota, United States
Status: Recruiting
Contact: Joseph W. Leach - 952-993-1517 - MMCCOP@parknicollet.com
Rice Memorial Hospital
Willmar, Minnesota, United States
Status: Recruiting
Contact: Joseph W. Leach - 952-993-1517 - MMCCOP@parknicollet.com
Minnesota Oncology and Hematology PA-Woodbury
Woodbury, Minnesota, United States
Status: Recruiting
Contact: Joseph W. Leach - 952-993-1517 - MMCCOP@parknicollet.com
Saint Francis Medical Center
Cape Girardeau, Missouri, United States
Status: Active, not recruiting
Cooper Hospital University Medical Center
Camden, New Jersey, United States
Status: Withdrawn
Veterans Adminstration New Jersey Health Care System
East Orange, New Jersey, United States
Status: Recruiting
Contact: Basil S. Kasimis - 800-475-2336 - patricia.goyer@med.va.gov
Hunterdon Medical Center
Flemington, New Jersey, United States
Status: Terminated
Cancer Institute of New Jersey At Hamilton
Hamilton, New Jersey, United States
Status: Recruiting
Contact: Kevin A. David - 732-235-8675
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County
Mount Holly, New Jersey, United States
Status: Withdrawn
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Status: Recruiting
Contact: Kevin A. David - 732-235-8675
UMDNJ - New Jersey Medical School
Newark, New Jersey, United States
Status: Active, not recruiting
New York University Langone Medical Center
New York, New York, United States
Status: Active, not recruiting
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota, United States
Status: Active, not recruiting
Roger Maris Cancer Center
Fargo, North Dakota, United States
Status: Recruiting
Contact: Preston D. Steen - 701-234-6161
Sanford Clinic North-Fargo
Fargo, North Dakota, United States
Status: Recruiting
Contact: Preston D. Steen - 701-234-6161
Sanford Medical Center-Fargo
Fargo, North Dakota, United States
Status: Recruiting
Contact: Preston D. Steen - 701-234-6161
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, United States
Status: Recruiting
Contact: Jennifer E. Payne - 330-375-6101
Toledo Clinic Cancer Centers-Bowling Green
Bowling Green, Ohio, United States
Status: Terminated
Aultman Health Foundation
Canton, Ohio, United States
Status: Withdrawn
Mercy Medical Center
Canton, Ohio, United States
Status: Recruiting
Contact: Mitchell Haut - 888-293-4673
Geaugra Hospital
Chardon, Ohio, United States
Status: Recruiting
Contact: Paolo F. Caimi - 800-641-2422
Case Western Reserve University
Cleveland, Ohio, United States
Status: Recruiting
Contact: Paolo F. Caimi - 800-641-2422
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Status: Recruiting
Contact: Paolo F. Caimi - 800-641-2422
MetroHealth Medical Center
Cleveland, Ohio, United States
Status: Recruiting
Contact: Bruce J. Averbook - 216-778-8526 - kbauchens@metrohealth.org
Ireland Cancer Center Landerbrook Health Center
Mayfield Heights, Ohio, United States
Status: Recruiting
Contact: Paolo F. Caimi - 800-641-2422
Lake University Ireland Cancer Center
Mentor, Ohio, United States
Status: Recruiting
Contact: Paolo F. Caimi - 800-641-2422
Southwest General Health Center Ireland Cancer Center
Middleburg Heights, Ohio, United States
Status: Recruiting
Contact: Paolo F. Caimi - 800-641-2422
UHHS-Chagrin Highlands Medical Center
Orange Village, Ohio, United States
Status: Recruiting
Contact: Paolo F. Caimi - 800-641-2422
Toledo Clinic Cancer Centers-Oregon
Oregon, Ohio, United States
Status: Terminated
Ireland Cancer Center at Firelands Regional Medical Center
Sandusky, Ohio, United States
Status: Recruiting
Contact: Paolo F. Caimi - 800-641-2422
Flower Hospital
Sylvania, Ohio, United States
Status: Terminated
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, United States
Status: Recruiting
Contact: Rex B. Mowat - 517-265-0116
Toledo Community Hospital Oncology Program CCOP
Toledo, Ohio, United States
Status: Active, not recruiting
University Hospitals Sharon Health Center
Wadsworth, Ohio, United States
Status: Recruiting
Contact: Paolo F. Caimi - 800-641-2422
UH-Seidman Cancer Center at Saint John Medical Center
Westlake, Ohio, United States
Status: Recruiting
Contact: Paolo F. Caimi - 800-641-2422
UHHS-Westlake Medical Center
Westlake, Ohio, United States
Status: Recruiting
Contact: Paolo F. Caimi - 800-641-2422
Abington Memorial Hospital
Abington, Pennsylvania, United States
Status: Recruiting
Contact: Willard G. Andrews - 215-481-2402
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States
Status: Withdrawn
Geisinger Medical Center
Danville, Pennsylvania, United States
Status: Recruiting
Contact: Edward J. Gorak - 570-271-5251
Ephrata Cancer Center
Ephrata, Pennsylvania, United States
Status: Withdrawn
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, United States
Status: Recruiting
Contact: Edward J. Gorak - 570-271-5251
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States
Status: Active, not recruiting
Geisinger Medical Oncology at Evangelical Community Hospital
Lewisburg, Pennsylvania, United States
Status: Recruiting
Contact: Edward J. Gorak - 570-271-5251
Lewistown Hospital
Lewistown, Pennsylvania, United States
Status: Recruiting
Contact: Edward J. Gorak - 570-271-5251
Paoli Memorial Hospital
Paoli, Pennsylvania, United States
Status: Withdrawn
Aria Health-Torresdale Campus
Philadelphia, Pennsylvania, United States
Status: Terminated
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
Status: Active, not recruiting
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Status: Recruiting
Contact: Barbara Pro - 215-955-6084
Geisinger Medical Oncology-Pottsville
Pottsville, Pennsylvania, United States
Status: Recruiting
Contact: Edward J. Gorak - 570-271-5251
Hematology and Oncology Associates of North East Pennsylvania
Scranton, Pennsylvania, United States
Status: Recruiting
Contact: Barbara Pro - 215-955-6084
Geisinger Medical Group
State College, Pennsylvania, United States
Status: Recruiting
Contact: Edward J. Gorak - 570-271-5251
Mount Nittany Medical Center
State College, Pennsylvania, United States
Status: Active, not recruiting
Reading Hospital
West Reading, Pennsylvania, United States
Status: Recruiting
Contact: Terrence P. Cescon - 610-988-9323
Geisinger Wyoming Valley
Wilkes-Barre, Pennsylvania, United States
Status: Recruiting
Contact: Edward J. Gorak - 570-271-5251
Lankenau Medical Center
Wynnewood, Pennsylvania, United States
Status: Withdrawn
Sanford Cancer Center-Oncology Clinic
Sioux Falls, South Dakota, United States
Status: Recruiting
Contact: Preston D. Steen - 701-234-6161
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States
Status: Recruiting
Contact: Preston D. Steen - 701-234-6161
Vanderbilt-Ingram Cancer Center Cool Springs
Franklin, Tennessee, United States
Status: Active, not recruiting
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Status: Recruiting
Contact: Nishitha Reddy - 800-811-8480
Parkland Memorial Hospital
Dallas, Texas, United States
Status: Active, not recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Status: Recruiting
Contact: Harris V. Naina - 214-648-7097
West Virginia University Charleston
Charleston, West Virginia, United States
Status: Recruiting
Contact: Steven J. Jubelirer - 304-344-3457
West Virginia University Healthcare
Morgantown, West Virginia, United States
Status: Recruiting
Contact: Abraham S. Kanate - 304-293-2745 - sfilburn@hsc.wvu.edu
Langlade Hospital and Cancer Center
Antigo, Wisconsin, United States
Status: Recruiting
Contact: Hamied R. Rezazadeh - 877-405-6866
Fox Valley Hematology and Oncology
Appleton, Wisconsin, United States
Status: Recruiting
Contact: William A. Conkright - 920-749-1171
Marshfield Clinic-Chippewa Center
Chippewa Falls, Wisconsin, United States
Status: Active, not recruiting
Marshfield Clinic Cancer Center at Sacred Heart
Eau Claire, Wisconsin, United States
Status: Active, not recruiting
Aurora BayCare Medical Center
Green Bay, Wisconsin, United States
Status: Active, not recruiting
Bellin Memorial Hospital
Green Bay, Wisconsin, United States
Status: Active, not recruiting
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, United States
Status: Recruiting
Contact: Brian L. Burnette - 800-432-6049
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin, United States
Status: Recruiting
Contact: Brian L. Burnette - 800-432-6049
Saint Mary's Hospital
Green Bay, Wisconsin, United States
Status: Recruiting
Contact: Brian L. Burnette - 800-432-6049
Saint Vincent Hospital
Green Bay, Wisconsin, United States
Status: Recruiting
Contact: Brian L. Burnette - 800-432-6049
UW Cancer Center Johnson Creek
Johnson Creek, Wisconsin, United States
Status: Active, not recruiting
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States
Status: Recruiting
Contact: Kurt Oettel - 608-775-2385 - cancerctr@gundluth.org
Dean Hematology and Oncology Clinic
Madison, Wisconsin, United States
Status: Active, not recruiting
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Status: Recruiting
Contact: Brad S. Kahl - 877-405-6866
Vince Lombardi Cancer Clinic-Marinette
Marinette, Wisconsin, United States
Status: Active, not recruiting
Marshfield Clinic
Marshfield, Wisconsin, United States
Status: Active, not recruiting
Saint Joseph's Hospital
Marshfield, Wisconsin, United States
Status: Active, not recruiting
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Status: Recruiting
Contact: Timothy S. Fenske - 414-805-4380
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, United States
Status: Active, not recruiting
Oconomowoc Memorial Hospital-ProHealth Care Inc
Oconomowoc, Wisconsin, United States
Status: Recruiting
Contact: Timothy R. Wassenaar - 262-928-7878
Green Bay Oncology - Oconto Falls
Oconto Falls, Wisconsin, United States
Status: Recruiting
Contact: Brian L. Burnette - 800-432-6049
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, United States
Status: Active, not recruiting
Marshfield Clinic at James Beck Cancer Center
Rhinelander, Wisconsin, United States
Status: Active, not recruiting
Saint Mary's Hospital
Rhinelander, Wisconsin, United States
Status: Active, not recruiting
Marshfield Clinic-Rice Lake Center
Rice Lake, Wisconsin, United States
Status: Active, not recruiting
Saint Nicholas Hospital
Sheboygan, Wisconsin, United States
Status: Recruiting
Contact: Brian L. Burnette - 800-432-6049
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, United States
Status: Active, not recruiting
Marshfield Clinic Cancer Care at Saint Michael's Hospital
Stevens Point, Wisconsin, United States
Status: Active, not recruiting
Saint Michael's Hospital
Stevens Point, Wisconsin, United States
Status: Active, not recruiting
Green Bay Oncology - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States
Status: Recruiting
Contact: Brian L. Burnette - 800-432-6049
Aurora Medical Center in Summit
Summit, Wisconsin, United States
Status: Active, not recruiting
Vince Lombardi Cancer Clinic
Two Rivers, Wisconsin, United States
Status: Active, not recruiting
Waukesha Memorial Hospital - ProHealth Care
Waukesha, Wisconsin, United States
Status: Recruiting
Contact: Timothy R. Wassenaar - 262-928-7878
Aspirus Regional Cancer Center
Wausau, Wisconsin, United States
Status: Recruiting
Contact: Hamied R. Rezazadeh - 877-405-6866
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, United States
Status: Active, not recruiting
Diagnostic and Treatment Center
Weston, Wisconsin, United States
Status: Active, not recruiting
Marshfield Clinic - Weston Center
Weston, Wisconsin, United States
Status: Active, not recruiting
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, United States
Status: Active, not recruiting
Riverview Hospital
Wisconsin Rapids, Wisconsin, United States
Status: Recruiting
Contact: Ronnie J. Kirschling - 877-405-6866
Start Date
December 2010
Sponsors
Eastern Cooperative Oncology Group
Source
Eastern Cooperative Oncology Group
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page