Rituximab, Bendamustine Hydrochloride, and Bortezomib Followed by Rituximab and Lenalidomide in Treating Older Patients With Previously Untreated Mantle Cell Lymphoma

Sponsor
Eastern Cooperative Oncology Group (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01415752
Collaborator
National Cancer Institute (NCI) (NIH)
373
418
8
231.3
0.9
0

Study Details

Study Description

Brief Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as bendamustine hydrochloride, also work in different ways to kill cancer cells or stop them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may stop the growth of mantle cell lymphoma by blocking blood flow to the cancer. It is not yet known whether giving rituximab together with bendamustine and bortezomib is more effective than rituximab and bendamustine, followed by rituximab alone or with lenalidomide in treating mantle cell lymphoma.

PURPOSE: This randomized phase II trial studies rituximab, bortezomib, bendamustine, and lenalidomide in treating previously untreated older patients with mantle cell lymphoma.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

OBJECTIVES:

Primary

  • To determine whether the addition of bortezomib (RBV) to an induction regimen of rituximab-bendamustine hydrochloride (RB) improves progression-free survival (PFS) compared to RB alone in patients ≥ 60 years of age with previously untreated mantle cell lymphoma.

  • To determine whether the addition of lenalidomide to a consolidation regimen of rituximab following an induction regimen of RB or RBV improves PFS compared to consolidation rituximab alone in this patient population.

Secondary

  • To determine whether the addition of bortezomib to induction therapy improves the positron emission tomography (PET)-documented complete response (CR) rate compared to RB alone.

  • To determine the objective response rate (ORR) for RB and RBV.

  • Among patients who do not have PET-documented CR at the end of induction, to determine whether the addition of lenalidomide to consolidation therapy improves CR and ORR compared with rituximab alone.

  • To determine overall survival (OS) in the treatment arms.

  • To determine safety, with attention to the addition of bortezomib in the induction regimen and lenalidomide-rituximab (LR) as consolidation therapy.

  • To collect paraffin-embedded tissue for creation of tissue microarray.

  • To collect and bank serum and blood mononuclear cells for future studies.

  • To collect formalin-fixed paraffin-embedded (FFPE) tissue to analyze potential prognostic factors (Ki-67 proliferation index by immunohistochemistry and correlation with proposed 5-gene set of proliferation markers analyzed by RNA PCR; SOX 11 expression by immunohistochemistry; and Micro-RNA levels by microarray).

  • Using patient-reported outcomes data, to determine the extent and severity of neuropathy associated with the addition of bortezomib to induction treatment.

  • Using patient-reported outcomes data, to determine the extent and severity of fatigue associated with the addition of lenalidomide to consolidation treatment.

  • To evaluate the effects of the addition of bortezomib and lenalidomide on patient-reported health-related quality of life.

  • To evaluate the effects of bortezomib-related neuropathy on patient-reported health-related quality of life.

  • To evaluate the response of lymphoma-specific symptoms to treatment.

  • Using longitudinal patient-reported outcomes data, to describe the trajectory of lymphoma symptoms, neuropathy, fatigue, and overall health-related quality of life prior to, during, and following treatment among older adults with MCL.

Tertiary

  • To assess the proportion of patients up and down staging when fludeoxyglucose F 18- (FDG) PET/CT is added to standard Ann Arbor staging.

  • To assess the ability of pre-treatment FDG-PET/CT (SUVmax) to predict response rate and PFS.

  • Among patients with interim (post-cycle 3) FDG-PET/CT imaging, to assess the correlation of interim FDG-PET/CT imaging with response rate and PFS both during induction and consolidation therapy.

  • To assess standard FDG-PET/CT metrics including SUVmax, tumor metabolic burden, total tumor burden, and association with pathology features (blastoid variant vs other, and Ki67) in the setting of MCL.

  • To assess differences in overall and CR rates when using Deauville vs International Harmonization Project FDG-PET/CT interpretation criteria.

  • To determine whether there is a correlation between FDG-PET/CT response and residual disease assessment by molecular and/or flow cytometric techniques.

  • To determine whether the number of malignant cells in circulation predict the number of cells in marrow.

  • To determine whether the number of malignant cells in circulation/in marrow at the end of induction correlate with CR and 2-year PFS.

  • To determine whether there is a higher rate of minimal residual disease (MRD) negativity among patients randomized to RBV as compared with RB, and among patients treated with LR maintenance compared with rituximab.

  • To compare the two methods of MRD detection - molecular techniques and flow cytometry - as prognostic markers for outcome.

OUTLINE: This is a multicenter study. Patients are stratified according to mantle cell lymphoma International Prognostic Index risk score (low vs intermediate vs high). Patients are randomized to 1 of 4 treatment arms.

  • Arm A: Patients receive induction therapy comprising rituximab IV on day 1 and bendamustine hydrochloride IV over 60 minutes on days 1-2. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

  • Arm E: Patients receive consolidation therapy comprising rituximab IV on day 1. Courses repeat every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.

  • Arm B: Patients receive induction therapy comprising bortezomib IV or subcutaneously (SC) on days 1, 4, 8, and 11 and rituximab and bendamustine hydrochloride as patients in arm A. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

  • Arm F: Patients receive consolidation therapy comprising rituximab IV on day 1. Courses repeat every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.

  • Arm C: Patients receive induction therapy comprising rituximab and bendamustine hydrochloride as patients in arm A. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

  • Arm G: Patients receive consolidation therapy comprising lenalidomide orally (PO) daily on days 1-21 every 4 weeks and rituximab IV every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.

  • Arm D: Patients receive bortezomib, rituximab, and bendamustine hydrochloride as patients in arm B. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

  • Arm H: Patients receive consolidation therapy comprising lenalidomide PO daily on days 1-21 every 4 weeks and rituximab IV every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.

Patients may undergo blood and bone marrow sample collection at baseline and during treatment for correlative studies.

Patients complete the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym), the FACT/GOG-Neurotoxicity scale (FACT/GOG-Ntx), FACT-Fatigue, and FACT-General questionnaires at baseline and periodically during study and follow up.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually for 10 years.

Study Design

Study Type:
Interventional
Actual Enrollment :
373 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Intergroup Randomized Phase 2 Four Arm Study In Patients ≥ 60 With Previously Untreated Mantle Cell Lymphoma Of Therapy With: Arm A = Rituximab+ Bendamustine Followed By Rituximab Consolidation (RB → R); Arm B = Rituximab + Bendamustine + Bortezomib Followed By Rituximab Consolidation (RBV→ R), Arm C = Rituximab + Bendamustine Followed By Lenalidomide + Rituximab Consolidation (RB → LR) or Arm D = Rituximab + Bendamustine + Bortezomib Followed By Lenalidomide + Rituximab Consolidation (RBV → LR)
Actual Study Start Date :
May 22, 2012
Actual Primary Completion Date :
May 28, 2022
Anticipated Study Completion Date :
Sep 1, 2031

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A

Patients receive induction therapy comprising rituximab IV on day 1 and bendamustine hydrochloride IV over 60 minutes on days 1-2. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to arm E.

Biological: rituximab
Given IV

Drug: bendamustine hydrochloride
Given IV

Experimental: Arm B

Patients receive induction therapy comprising bortezomib IV subcutaneously (SC) on days 1, 4, 8, and 11 and rituximab and bendamustine hydrochloride as patients in arm A. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to arm F.

Biological: rituximab
Given IV

Drug: bendamustine hydrochloride
Given IV

Drug: bortezomib
Given IV or SC

Experimental: Arm C

Patients receive induction therapy comprising rituximab and bendamustine hydrochloride as patients in arm A. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to arm G.

Biological: rituximab
Given IV

Drug: bendamustine hydrochloride
Given IV

Drug: lenalidomide
Given PO

Experimental: Arm D

Patients receive bortezomib, rituximab, and bendamustine hydrochloride as patients in arm B. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to arm H.

Biological: rituximab
Given IV

Drug: bendamustine hydrochloride
Given IV

Drug: bortezomib
Given IV or SC

Drug: lenalidomide
Given PO

Experimental: Arm E

Patients receive consolidation therapy comprising rituximab IV on day 1. Courses repeat every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.

Biological: rituximab
Given IV

Experimental: Arm F

Patients receive consolidation therapy comprising rituximab IV on day 1. Courses repeat every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.

Biological: rituximab
Given IV

Experimental: Arm G

Patients receive consolidation therapy comprising lenalidomide orally (PO) daily on days 1-21 every 4 weeks and rituximab IV every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.

Biological: rituximab
Given IV

Drug: lenalidomide
Given PO

Experimental: Arm H

Patients receive consolidation therapy comprising lenalidomide PO daily on days 1-21 every 4 weeks and rituximab IV every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.

Biological: rituximab
Given IV

Drug: lenalidomide
Given PO

Outcome Measures

Primary Outcome Measures

  1. 2-year PFS rate of patients treated with RBV to an induction regimen of RB compared to RB alone []

  2. PFS improvement of patients treated with lenalidomide added to a consolidation regimen []

Secondary Outcome Measures

  1. PET-documented CR rate []

  2. Response rate to RB and RBV []

  3. Toxicity []

  4. Quality of life []

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years to 120 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
DISEASE CHARACTERISTICS:
  • Histologically confirmed untreated mantle cell lymphoma (MCL), with documented cyclin D1 by immunohistochemical stains and/or t(11;14) by cytogenetics or fluorescence in situ hybridization (FISH)

  • Patients must have at least one objective measurable disease parameter

  • Abnormal PET scans will not constitute evaluable disease, unless verified by CT scan or other appropriate imaging

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

  • Patient must have no CNS involvement

PATIENT CHARACTERISTICS:
  • ECOG performance status 0-2

  • ANC ≥ 1,500/mcL (1.5 x 10^9/L)*

  • Platelets ≥ 100,000/mcL (100 x 10^9/L)* NOTE: *Unless due to marrow involvement.

  • AST/ALT ≤ 2 times upper limit of normal (ULN)

  • Bilirubin ≤ 2 times ULN

  • Calculated creatinine clearance by Cockroft-Gault formula ≥ 30 mL/min

  • Women (sexually mature female) must not be pregnant or breast-feeding

  • Negative pregnancy test

  • Women of childbearing potential and sexually active males use an accepted and effective method of contraception

  • Men must agree to use a latex condom during sexual contact with a female of child-bearing potential, even if they have had a successful vasectomy

  • All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure

  • No evidence of prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical carcinoma, or any surgically or radiation-cured malignancy continuously disease free for ≥ 5 years so as not to interfere with interpretation of radiographic response

  • Patient agrees that if randomized to Arms C or D, and proceed onto Arms G or H, they must register into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®

  • Patients must have no medical contra-indications to, and be willing to take, deep vein thrombosis (DVT) prophylaxis as all patients registering to the lenalidomide/rituximab Arms G and H will be required to have DVT prophylaxis

  • Patients randomized to Arms G or H who have a history of a thrombotic vascular event will be required to have therapeutic doses of low-molecular weight heparin or warfarin to maintain an INR between 2.0 - 3.0

  • Patients on Arms G and H without a history of a thromboembolic event are required to take a daily aspirin (81 mg or 325 mg) for DVT prophylaxis

  • Patients who are unable to tolerate aspirin should receive low molecular weight heparin therapy or warfarin treatment

  • Women must agree to abstain from donating blood during study participation and for at least 28 days after discontinuation from protocol treatment

  • Males must agree to abstain from donating blood, semen, or sperm during study participation and for at least 28 days after discontinuation from protocol treatment

  • HIV-positive patients are not excluded but, to enroll, must meet all of the below criteria:

  • HIV is sensitive to antiretroviral therapy

  • Must be willing to take effective antiretroviral therapy, if indicated

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

  • 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 until at least 2 months following the completion of therapy or until the CD4 cells recover to over 250 cells/mm³, whichever occurs later

  • Patients must not have grade 2 or greater peripheral neuropathy

  • Patients must not have NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia

  • Patients must not have hypersensitivity to bortezomib, boron, or mannitol

  • Patients must not have a serious medical or psychiatric illness likely to interfere with study participation

PRIOR CONCURRENT THERAPY:
  • No prior therapy for MCL, except < 1 week of steroid therapy for symptom control

  • HIV-positive patients are not excluded, but to enroll, must meet all of the below criteria:

  • Must be willing to take effective antiretroviral therapy if indicated

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

  • Patients must not be participating in any other clinical trial or taking any other experimental medications within 14 days prior to registration

Contacts and Locations

Locations

Site City State Country Postal Code
1 Alaska Breast Care and Surgery LLC Anchorage Alaska United States 99508
2 Alaska Women's Cancer Care Anchorage Alaska United States 99508
3 Anchorage Oncology Centre Anchorage Alaska United States 99508
4 Katmai Oncology Group Anchorage Alaska United States 99508
5 Providence Alaska Medical Center Anchorage Alaska United States 99508
6 Kaiser Permanente-Deer Valley Medical Center Antioch California United States 94531
7 Kaiser Permanente, Fremont Fremont California United States 94538
8 Kaiser Permanente Fresno California United States 93720
9 Los Angeles County-USC Medical Center Los Angeles California United States 90033
10 USC / Norris Comprehensive Cancer Center Los Angeles California United States 90033
11 Kaiser Permanente-Modesto Modesto California United States 95356
12 Kaiser Permanente-Oakland Oakland California United States 94611
13 Kaiser Permanente-Redwood City Redwood City California United States 94063
14 Kaiser Permanente-Richmond Richmond California United States 94801
15 Kaiser Permanente-Roseville Roseville California United States 95661
16 Kaiser Permanente-South Sacramento Sacramento California United States 95823
17 Kaiser Permanente - Sacramento Sacramento California United States 95825
18 Kaiser Permanente-San Francisco San Francisco California United States 94115
19 Kaiser Permanente-Santa Teresa-San Jose San Jose California United States 95119
20 Kaiser Permanente San Leandro San Leandro California United States 94577
21 Kaiser Permanente-San Rafael San Rafael California United States 94903
22 Kaiser Permanente Medical Center - Santa Clara Santa Clara California United States 95051
23 Kaiser Permanente-Santa Rosa Santa Rosa California United States 95403
24 Kaiser Permanente-South San Francisco South San Francisco California United States 94080
25 Stanford University Hospitals and Clinics Stanford California United States 94305
26 Kaiser Permanente-Stockton Stockton California United States 95210
27 Kaiser Permanente Medical Center-Vacaville Vacaville California United States 95688
28 Kaiser Permanente-Vallejo Vallejo California United States 94589
29 Kaiser Permanente-Walnut Creek Walnut Creek California United States 94596
30 Rocky Mountain Cancer Centers-Aurora Aurora Colorado United States 80012
31 The Medical Center of Aurora Aurora Colorado United States 80012
32 Boulder Community Hospital Boulder Colorado United States 80301
33 Rocky Mountain Cancer Centers-Boulder Boulder Colorado United States 80304
34 Penrose-Saint Francis Healthcare Colorado Springs Colorado United States 80907
35 Rocky Mountain Cancer Centers-Penrose Colorado Springs Colorado United States 80907
36 Kaiser Permanente-Franklin Denver Colorado United States 80205
37 Porter Adventist Hospital Denver Colorado United States 80210
38 Exempla Saint Joseph Hospital Denver Colorado United States 80218
39 Presbyterian - Saint Lukes Medical Center - Health One Denver Colorado United States 80218
40 Rocky Mountain Cancer Centers-Midtown Denver Colorado United States 80218
41 Rocky Mountain Cancer Centers-Rose Denver Colorado United States 80220
42 Rose Medical Center Denver Colorado United States 80220
43 Colorado Cancer Research Program CCOP Denver Colorado United States 80224-2522
44 Colorado Blood Cancer Institute Denver Colorado United States 80907
45 Mercy Medical Center Durango Colorado United States 81301
46 Southwest Oncology PC Durango Colorado United States 81301
47 Comprehensive Cancer Care and Research Institute of Colorado LLC Englewood Colorado United States 80113
48 Swedish Medical Center Englewood Colorado United States 80113
49 Poudre Valley Hospital Fort Collins Colorado United States 80524
50 Mountain Blue Cancer Care Center Golden Colorado United States 80401
51 North Colorado Medical Center Greeley Colorado United States 80631
52 Rocky Mountain Cancer Centers-Greenwood Village Greenwood Village Colorado United States 80111
53 Kaiser Permanente-Rock Creek Lafayette Colorado United States 80026
54 Rocky Mountain Cancer Centers-Lakewood Lakewood Colorado United States 80228
55 Saint Anthony Hospital Lakewood Colorado United States 80228
56 Rocky Mountain Cancer Centers-Littleton Littleton Colorado United States 80120
57 Littleton Adventist Hospital Littleton Colorado United States 80122
58 Kaiser Permanente-Lone Tree Lone Tree Colorado United States 80124
59 Rocky Mountain Cancer Centers-Sky Ridge Lone Tree Colorado United States 80124
60 Sky Ridge Medical Center Lone Tree Colorado United States 80124
61 Longmont United Hospital Longmont Colorado United States 80501
62 Rocky Mountain Cancer Centers-Longmont Longmont Colorado United States 80501
63 McKee Medical Center Loveland Colorado United States 80539
64 Parker Adventist Hospital Parker Colorado United States 80138
65 Rocky Mountain Cancer Centers-Parker Parker Colorado United States 80138
66 Saint Mary Corwin Medical Center Pueblo Colorado United States 81004
67 Rocky Mountain Cancer Centers - Pueblo Pueblo Colorado United States 81008
68 Rocky Mountain Cancer Centers-Thornton Thornton Colorado United States 80260
69 Exempla Lutheran Medical Center Wheat Ridge Colorado United States 80033
70 Saint Francis Hospital and Medical Center Hartford Connecticut United States 06105
71 Beebe Medical Center Lewes Delaware United States 19958
72 Christiana Gynecologic Oncology LLC Newark Delaware United States 19713
73 Delaware Clinical and Laboratory Physicians PA Newark Delaware United States 19713
74 Helen F Graham Cancer Center Newark Delaware United States 19713
75 Medical Oncology Hematology Consultants PA Newark Delaware United States 19713
76 Regional Hematology and Oncology PA Newark Delaware United States 19713
77 Christiana Care Health System-Christiana Hospital Newark Delaware United States 19718
78 Beebe Health Campus Rehoboth Beach Delaware United States 19971
79 Nanticoke Memorial Hospital Seaford Delaware United States 19973
80 Christiana Care Health System-Wilmington Hospital Wilmington Delaware United States 19801
81 Lombardi Comprehensive Cancer Center at Georgetown University Washington District of Columbia United States 20057
82 Baptist Cancer Institute Jacksonville Florida United States 32207
83 UF Cancer Center at Orlando Health Orlando Florida United States 32806
84 Oncare Hawaii Inc-Pali Momi 'Aiea Hawaii United States 96701
85 Pali Momi Medical Center 'Aiea Hawaii United States 96701
86 Oncare Hawaii Inc-POB II Honolulu Hawaii United States 96813
87 Queen's Medical Center Honolulu Hawaii United States 96813
88 Straub Clinic and Hospital Honolulu Hawaii United States 96813
89 University of Hawaii Cancer Center Honolulu Hawaii United States 96813
90 OnCare Hawaii-Liliha Honolulu Hawaii United States 96817-3169
91 Oncare Hawaii Inc-Kuakini Honolulu Hawaii United States 96817
92 Kaiser Permanente Moanalua Medical Center Honolulu Hawaii United States 96819
93 Kapiolani Medical Center for Women and Children Honolulu Hawaii United States 96826
94 Castle Medical Center Kailua Hawaii United States 96734
95 Wilcox Memorial Hospital and Kauai Medical Clinic Lihue Hawaii United States 96766
96 Saint Alphonsus Cancer Care Center-Boise Boise Idaho United States 83706
97 Idaho Urologic Institute-Meridian Meridian Idaho United States 83642
98 Kootenai Cancer Center Post Falls Idaho United States 83854
99 Kootenai Cancer Sandpoint Idaho United States 83864
100 Memorial Hospital of Carbondale Carbondale Illinois United States 62902
101 Centralia Oncology Clinic Centralia Illinois United States 62801
102 Mount Sinai Hospital Medical Center Chicago Illinois United States 60608
103 Hematology and Oncology Associates Chicago Illinois United States 60611
104 Northwestern University Chicago Illinois United States 60611
105 John H Stroger Jr Hospital of Cook County Chicago Illinois United States 60612-3785
106 Carle on Vermilion Danville Illinois United States 61832
107 Cancer Care Center of Decatur Decatur Illinois United States 62526
108 Decatur Memorial Hospital Decatur Illinois United States 62526
109 Carle Physician Group-Effingham Effingham Illinois United States 62401
110 Crossroads Cancer Center Effingham Illinois United States 62401
111 Hematology Oncology Associates of Illinois-Highland Park Highland Park Illinois United States 60035
112 Presence Saint Mary's Hospital Kankakee Illinois United States 60901
113 North Shore Hematology Oncology Libertyville Illinois United States 60048
114 Carle Physician Group-Mattoon/Charleston Mattoon Illinois United States 61938
115 Good Samaritan Regional Health Center Mount Vernon Illinois United States 62864
116 Illinois Cancer Specialists-Niles Niles Illinois United States 60714
117 SwedishAmerican Regional Cancer Center/ACT Rockford Illinois United States 61107
118 Hematology Oncology Associates of Illinois - Skokie Skokie Illinois United States 60076
119 Memorial Medical Center Springfield Illinois United States 62781-0001
120 Carle Cancer Center Urbana Illinois United States 61801
121 The Carle Foundation Hospital Urbana Illinois United States 61801
122 IU Health Arnett Cancer Care Lafayette Indiana United States 47904
123 Franciscan Saint Anthony Health-Michigan City Michigan City Indiana United States 46360
124 Woodland Cancer Care Center Michigan City Indiana United States 46360
125 Reid Hospital and Health Care Services Richmond Indiana United States 47374
126 Mary Greeley Medical Center Ames Iowa United States 50010
127 McFarland Clinic PC-William R Bliss Cancer Center Ames Iowa United States 50010
128 Hematology Oncology Associates-Quad Cities Bettendorf Iowa United States 52722
129 McFarland Clinic PC-Boone Boone Iowa United States 50036
130 Cedar Rapids Oncology Association Cedar Rapids Iowa United States 52403
131 Mercy Hospital Cedar Rapids Iowa United States 52403
132 Oncology Associates at Mercy Medical Center Cedar Rapids Iowa United States 52403
133 McFarland Clinic PC-Trinity Cancer Center Fort Dodge Iowa United States 50501
134 McFarland Clinic PC-Jefferson Jefferson Iowa United States 50129
135 McFarland Clinic PC-Marshalltown Marshalltown Iowa United States 50158
136 Siouxland Hematology Oncology Associates Sioux City Iowa United States 51101
137 Mercy Medical Center-Sioux City Sioux City Iowa United States 51104
138 Saint Luke's Regional Medical Center Sioux City Iowa United States 51104
139 Lawrence Memorial Hospital Lawrence Kansas United States 66044
140 Menorah Medical Center Overland Park Kansas United States 66209
141 Saint Luke's South Hospital Overland Park Kansas United States 66213
142 Kansas City CCOP Prairie Village Kansas United States 66208
143 Wesley Medical Center Wichita Kansas United States 67214
144 Oncology Hematology Care Inc-Crestview Crestview Hills Kentucky United States 41017
145 Ochsner Health Center-Summa Baton Rouge Louisiana United States 70809
146 Ochsner Baptist Medical Center New Orleans Louisiana United States 70115
147 Ochsner Medical Center Jefferson New Orleans Louisiana United States 70121
148 Harold Alfond Center for Cancer Care Augusta Maine United States 04330
149 Eastern Maine Medical Center Bangor Maine United States 04401
150 Penobscot Bay Medical Center Rockport Maine United States 04856
151 Franklin Square Hospital Center Baltimore Maryland United States 21237
152 Union Hospital of Cecil County Elkton Maryland United States 21921
153 Holy Cross Hospital Silver Spring Maryland United States 20910
154 Tufts Medical Center Boston Massachusetts United States 02111
155 Simonds-Sinon Regional Cancer Center Fitchburg Massachusetts United States 01420
156 Baystate Medical Center Springfield Massachusetts United States 01199
157 University of Massachusetts Medical School Worcester Massachusetts United States 01655
158 Saint Joseph Mercy Hospital Ann Arbor Michigan United States 48106-0995
159 Michigan Cancer Research Consortium Community Clinical Oncology Program Ann Arbor Michigan United States 48106
160 Bronson Battle Creek Battle Creek Michigan United States 49017
161 Spectrum Health Big Rapids Hospital Big Rapids Michigan United States 49307
162 Oakwood Hospital and Medical Center Dearborn Michigan United States 48124
163 Wayne State University/Karmanos Cancer Institute Detroit Michigan United States 48201
164 Saint John Hospital and Medical Center Detroit Michigan United States 48236
165 Green Bay Oncology - Escanaba Escanaba Michigan United States 49431
166 Weisberg Cancer Treatment Center Farmington Hills Michigan United States 48334
167 Hurley Medical Center Flint Michigan United States 48502
168 Genesys Hurley Cancer Institute Flint Michigan United States 48503
169 Genesys Regional Medical Center Grand Blanc Michigan United States 48439
170 Grand Rapids Clinical Oncology Program Grand Rapids Michigan United States 49503
171 Mercy Health Saint Mary's Grand Rapids Michigan United States 49503
172 Spectrum Health at Butterworth Campus Grand Rapids Michigan United States 49503
173 Green Bay Oncology - Iron Mountain Iron Mountain Michigan United States 49801
174 Allegiance Health Jackson Michigan United States 49201
175 Borgess Medical Center Kalamazoo Michigan United States 49001
176 Bronson Methodist Hospital Kalamazoo Michigan United States 49007
177 West Michigan Cancer Center Kalamazoo Michigan United States 49007
178 Sparrow Hospital Lansing Michigan United States 48912
179 Saint Mary Mercy Hospital Livonia Michigan United States 48154
180 Mercy Health Mercy Campus Muskegon Michigan United States 49444
181 Lakeland Community Hospital Niles Michigan United States 49120
182 Saint Joseph Mercy Oakland Pontiac Michigan United States 48341
183 Saint Joseph Mercy Port Huron Port Huron Michigan United States 48060
184 Spectrum Health Reed City Hospital Reed City Michigan United States 49677
185 Saint Mary's of Michigan Saginaw Michigan United States 48601
186 Lakeland Hospital Saint Joseph Michigan United States 49085
187 Marie Yeager Cancer Center Saint Joseph Michigan United States 49085
188 Munson Medical Center Traverse City Michigan United States 49684
189 Saint John Macomb-Oakland Hospital Warren Michigan United States 48093
190 Sanford Clinic North-Bemidgi Bemidji Minnesota United States 56601
191 Fairview Ridges Hospital Burnsville Minnesota United States 55337
192 Mercy Hospital Coon Rapids Minnesota United States 55433
193 Essentia Health Cancer Center Duluth Minnesota United States 55805
194 Essentia Health Saint Mary's Medical Center Duluth Minnesota United States 55805
195 Miller-Dwan Hospital Duluth Minnesota United States 55805
196 Fairview-Southdale Hospital Edina Minnesota United States 55435
197 Unity Hospital Fridley Minnesota United States 55432
198 Hutchinson Area Health Care Hutchinson Minnesota United States 55350
199 Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota United States 55109
200 Saint John's Hospital - Healtheast Maplewood Minnesota United States 55109
201 Abbott-Northwestern Hospital Minneapolis Minnesota United States 55407
202 Hennepin County Medical Center Minneapolis Minnesota United States 55415
203 Health Partners Inc Minneapolis Minnesota United States 55454
204 New Ulm Medical Center New Ulm Minnesota United States 56073
205 North Memorial Medical Health Center Robbinsdale Minnesota United States 55422
206 Mayo Clinic Rochester Minnesota United States 55905
207 Metro-Minnesota CCOP Saint Louis Park Minnesota United States 55416
208 Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota United States 55416
209 Regions Hospital Saint Paul Minnesota United States 55101
210 United Hospital Saint Paul Minnesota United States 55102
211 Saint Francis Regional Medical Center Shakopee Minnesota United States 55379
212 Lakeview Hospital Stillwater Minnesota United States 55082
213 Ridgeview Medical Center Waconia Minnesota United States 55387
214 Rice Memorial Hospital Willmar Minnesota United States 56201
215 Minnesota Oncology and Hematology PA-Woodbury Woodbury Minnesota United States 55125
216 Parkland Health Center-Bonne Terre Bonne Terre Missouri United States 63628
217 Saint Francis Medical Center Cape Girardeau Missouri United States 63703
218 Southeast Cancer Center Cape Girardeau Missouri United States 63703
219 University of Missouri - Ellis Fischel Columbia Missouri United States 65212
220 Centerpoint Medical Center LLC Independence Missouri United States 64057
221 Capital Region Medical Center-Goldschmidt Cancer Center Jefferson City Missouri United States 65109
222 Freeman Health System Joplin Missouri United States 64804
223 Saint Luke's Hospital of Kansas City Kansas City Missouri United States 64111
224 Heartland Hematology and Oncology Associates Incorporated Kansas City Missouri United States 64118
225 Research Medical Center Kansas City Missouri United States 64132
226 Saint Luke's East - Lee's Summit Lee's Summit Missouri United States 64086
227 Liberty Radiation Oncology Center Liberty Missouri United States 64068
228 Phelps County Regional Medical Center Rolla Missouri United States 65401
229 Saint John's Clinic-Rolla-Cancer and Hematology Rolla Missouri United States 65401
230 Heartland Regional Medical Center Saint Joseph Missouri United States 64506
231 Saint Louis Cancer and Breast Institute-South City Saint Louis Missouri United States 63109
232 Washington University School of Medicine Saint Louis Missouri United States 63110
233 Missouri Baptist Medical Center Saint Louis Missouri United States 63131
234 Comprehensive Cancer Care PC Saint Louis Missouri United States 63141
235 Saint John's Mercy Medical Center Saint Louis Missouri United States 63141
236 Mercy Hospital Springfield Springfield Missouri United States 65804
237 Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield Springfield Missouri United States 65804
238 CoxHealth South Hospital Springfield Missouri United States 65807
239 Missouri Baptist Sullivan Hospital Sullivan Missouri United States 63080
240 Missouri Baptist Outpatient Center-Sunset Hills Sunset Hills Missouri United States 63127
241 Montana Cancer Consortium CCOP Billings Montana United States 59101
242 Saint Vincent Healthcare Billings Montana United States 59101
243 Frontier Cancer Center and Blood Institute-Billings Billings Montana United States 59102
244 Billings Clinic Cancer Center Billings Montana United States 59107
245 Bozeman Deaconess Hospital Bozeman Montana United States 59715
246 Saint James Community Hospital and Cancer Treatment Center Butte Montana United States 59701
247 Benefis Healthcare- Sletten Cancer Institute Great Falls Montana United States 59405
248 Great Falls Clinic Great Falls Montana United States 59405
249 Northern Montana Hospital Havre Montana United States 59501
250 Saint Peter's Community Hospital Helena Montana United States 59601
251 Glacier Oncology PLLC Kalispell Montana United States 59901
252 Kalispell Medical Oncology Kalispell Montana United States 59901
253 Kalispell Regional Medical Center Kalispell Montana United States 59901
254 Community Medical Hospital Missoula Montana United States 59801
255 Montana Cancer Specialists Missoula Montana United States 59802
256 Saint Patrick Hospital - Community Hospital Missoula Montana United States 59802
257 Dartmouth Hitchcock Medical Center Lebanon New Hampshire United States 03756
258 Norris Cotton Cancer Center Nashua Nashua New Hampshire United States 03063
259 Cooper Hospital University Medical Center Camden New Jersey United States 08103
260 Veterans Adminstration New Jersey Health Care System East Orange New Jersey United States 07018-1095
261 Hematology Oncology Associates of Central New York-Auburn Auburn New York United States 13021
262 Albert Einstein College of Medicine Bronx New York United States 10461
263 Montefiore Medical Center - Moses Campus Bronx New York United States 10467-2490
264 Hematology Oncology Associates of Central New York-East Syracuse East Syracuse New York United States 13057
265 Glens Falls Hospital Glens Falls New York United States 12801
266 Hematology Oncology Associates of Central New York-Liverpool Liverpool New York United States 13088
267 Orange Regional Medical Center Middletown New York United States 10940
268 Mount Sinai Medical Center New York New York United States 10029
269 Weill Medical College of Cornell University New York New York United States 10065
270 University of Rochester Rochester New York United States 14642
271 Hematology Oncology Associates of Central New York-Rome Rome New York United States 13440
272 Hematology Oncology Associates of Central New York-Onondaga Hill Syracuse New York United States 13215
273 Southeastern Medical Oncology Center-Clinton Clinton North Carolina United States 28328
274 Southeastern Medical Oncology Center-Goldsboro Goldsboro North Carolina United States 27534
275 Wayne Memorial Hospital Goldsboro North Carolina United States 27534
276 Hendersonville Hematology and Oncology at Pardee Hendersonville North Carolina United States 28739
277 Margaret R Pardee Memorial Hospital Hendersonville North Carolina United States 28791
278 Park Ridge Hospital Breast Health Center Hendersonville North Carolina United States 28792
279 Southeastern Medical Oncology Center-Jacksonville Jacksonville North Carolina United States 28546
280 Kinston Medical Specialists PA Kinston North Carolina United States 28501
281 Iredell Memorial Hospital Statesville North Carolina United States 28677
282 Southeastern Medical Oncology Center-Wilson Wilson North Carolina United States 27893
283 Wake Forest University Health Sciences Winston-Salem North Carolina United States 27157
284 Roger Maris Cancer Center Fargo North Dakota United States 58122
285 Sanford Clinic North-Fargo Fargo North Dakota United States 58122
286 Sanford Medical Center-Fargo Fargo North Dakota United States 58122
287 Summa Akron City Hospital/Cooper Cancer Center Akron Ohio United States 44304
288 Summa Barberton Hospital Barberton Ohio United States 44203
289 Cleveland Clinic Cancer Center Beachwood Beachwood Ohio United States 44122
290 Oncology Hematology Care Inc-Mercy West Cincinnati Ohio United States 45211
291 Oncology and Hematology Care Inc-Taft Cincinnati Ohio United States 45219
292 Oncology Hematology Care Inc - Anderson Cincinnati Ohio United States 45230
293 Oncology Hematology Care Inc - Kenwood Cincinnati Ohio United States 45236
294 Oncology Hematology Care Inc-Blue Ash Cincinnati Ohio United States 45242
295 University of Cincinnati Cincinnati Ohio United States 45267
296 Case Western Reserve University Cleveland Ohio United States 44106
297 MetroHealth Medical Center Cleveland Ohio United States 44109
298 Cleveland Clinic Cancer Center/Fairview Hospital Cleveland Ohio United States 44111
299 Cleveland Clinic Foundation Cleveland Ohio United States 44195
300 Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Columbus Ohio United States 43210
301 Grandview Hospital Dayton Ohio United States 45405
302 Good Samaritan Hospital - Dayton Dayton Ohio United States 45406
303 Miami Valley Hospital Dayton Ohio United States 45409
304 Samaritan North Health Center Dayton Ohio United States 45415
305 Dayton CCOP Dayton Ohio United States 45420
306 Mercy Cancer Center-Elyria Elyria Ohio United States 44035
307 Oncology Hematology Care Inc-Healthplex Fairfield Ohio United States 45014
308 Blanchard Valley Hospital Findlay Ohio United States 45840
309 Atrium Medical Center-Middletown Regional Hospital Franklin Ohio United States 45005-1066
310 Wayne Hospital Greenville Ohio United States 45331
311 Cleveland Clinic Cancer Center Independence Independence Ohio United States 44131
312 Kettering Medical Center Kettering Ohio United States 45429
313 Cleveland Clinic Cancer Center Mansfield Mansfield Ohio United States 44906
314 Hillcrest Hospital Cancer Center Mayfield Heights Ohio United States 44124
315 Lake University Ireland Cancer Center Mentor Ohio United States 44060
316 North Coast Cancer Care Sandusky Ohio United States 44870
317 Cleveland Clinic Cancer Center Strongsville Strongsville Ohio United States 44136
318 Upper Valley Medical Center Troy Ohio United States 45373
319 South Pointe Hospital Warrensville Heights Ohio United States 44122
320 University Pointe West Chester Ohio United States 45069
321 UH-Seidman Cancer Center at Saint John Medical Center Westlake Ohio United States 44145
322 Cleveland Clinic Wooster Specialty Center Wooster Ohio United States 44691
323 Greene Memorial Hospital Xenia Ohio United States 45385
324 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
325 Tulsa Cancer Institute Tulsa Oklahoma United States 74146
326 Clackamas Radiation Oncology Center Clackamas Oregon United States 97015
327 Providence Milwaukie Hospital Milwaukie Oregon United States 97222
328 Providence Newberg Medical Center Newberg Oregon United States 97132
329 Providence Willamette Falls Medical Center Oregon City Oregon United States 97045
330 Providence Portland Medical Center Portland Oregon United States 97213
331 Western Oncology Research Consortium Portland Oregon United States 97213
332 Providence Saint Vincent Medical Center Portland Oregon United States 97225
333 Geisinger Medical Center Danville Pennsylvania United States 17822
334 Geisinger Medical Center-Cancer Center Hazleton Hazleton Pennsylvania United States 18201
335 Geisinger Medical Oncology at Evangelical Community Hospital Lewisburg Pennsylvania United States 17837
336 Lewistown Hospital Lewistown Pennsylvania United States 17044
337 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111
338 Pottstown Memorial Medical Center Pottstown Pennsylvania United States 19464
339 Geisinger Medical Oncology-Pottsville Pottsville Pennsylvania United States 17901
340 Geisinger Medical Group State College Pennsylvania United States 16801
341 Mount Nittany Medical Center State College Pennsylvania United States 16803
342 Reading Hospital West Reading Pennsylvania United States 19611
343 Geisinger Wyoming Valley Wilkes-Barre Pennsylvania United States 18711
344 AnMed Health Cancer Center Anderson South Carolina United States 29621
345 Saint Francis Hospital Greenville South Carolina United States 29601
346 Gibbs Cancer Center-Pelham Greer South Carolina United States 29651
347 Spartanburg Regional Medical Center Spartanburg South Carolina United States 29303
348 Upstate Carolina CCOP Spartanburg South Carolina United States 29303
349 Wellmont Bristol Regional Medical Center Bristol Tennessee United States 37620
350 Wellmont Medical Associates Oncology and Hematology-Bristol Bristol Tennessee United States 37620
351 Wellmont Holston Valley Hospital and Medical Center Kingsport Tennessee United States 37660
352 Wellmont Medical Associates Oncology and Hematology-Kingsport Kingsport Tennessee United States 37660
353 Vanderbilt-Ingram Cancer Center Nashville Tennessee United States 37232
354 Parkland Memorial Hospital Dallas Texas United States 75235
355 University of Texas Southwestern Medical Center Dallas Texas United States 75390
356 University of Virginia Charlottesville Virginia United States 22908
357 Memorial Hospital Of Martinsville Martinsville Virginia United States 24115
358 Southwest VA Regional Cancer Center Norton Virginia United States 24273
359 Massey Cancer Center at Virginia Commonwealth University Richmond Virginia United States 23298-0037
360 Kadlec Clinic Hematology and Oncology Kennewick Washington United States 99336
361 EvergreenHealth Medical Center Kirkland Washington United States 98033
362 Seattle Cancer Care Alliance at EvergreenHealth Kirkland Washington United States 98034
363 Saint John Medical Center Longview Washington United States 98632
364 Skagit Valley Hospital Regional Cancer Care Center Mount Vernon Washington United States 98273
365 Skagit Valley Hospital Mount Vernon Washington United States 98274
366 Olympic Medical Center Port Angeles Washington United States 98362
367 Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Seattle Washington United States 98109
368 Seattle Cancer Care Alliance Seattle Washington United States 98109
369 University of Washington Medical Center Seattle Washington United States 98195
370 Olympic Medical Cancer Care Center Sequim Washington United States 98384
371 Cancer Care Northwest - Spokane South Spokane Washington United States 99202
372 Cancer Care Northwest-Valley Spokane Washington United States 99216
373 Cancer Care Northwest-North Spokane Spokane Washington United States 99218
374 PeaceHealth Southwest Medical Center Vancouver Washington United States 98664
375 Compass Oncology Vancouver Vancouver Washington United States 98684
376 Wenatchee Valley Hospital and Clinics Wenatchee Washington United States 98801
377 West Virginia University Healthcare Morgantown West Virginia United States 26506
378 Langlade Hospital and Cancer Center Antigo Wisconsin United States 54409
379 Marshfield Clinic Cancer Center at Sacred Heart Eau Claire Wisconsin United States 54701
380 Sacred Heart Hospital Eau Claire Wisconsin United States 54701
381 Agnesian Cancer Center Fond Du Lac Wisconsin United States 54935
382 Green Bay Oncology at Saint Vincent Hospital Green Bay Wisconsin United States 54301-3526
383 Saint Vincent Hospital Green Bay Wisconsin United States 54301
384 Green Bay Oncology Limited at Saint Mary's Hospital Green Bay Wisconsin United States 54303
385 Saint Mary's Hospital Green Bay Wisconsin United States 54303
386 UW Cancer Center Johnson Creek Johnson Creek Wisconsin United States 53038
387 Gundersen Lutheran Medical Center La Crosse Wisconsin United States 54601
388 University of Wisconsin Hospital and Clinics Madison Wisconsin United States 53792
389 Holy Family Memorial Hospital Manitowoc Wisconsin United States 54221
390 Bay Area Medical Center Marinette Wisconsin United States 54143
391 Marshfield Clinic Marshfield Wisconsin United States 54449
392 Saint Joseph's Hospital Marshfield Wisconsin United States 54449
393 Froedtert and the Medical College of Wisconsin Milwaukee Wisconsin United States 53226
394 Marshfield Clinic-Minocqua Center Minocqua Wisconsin United States 54548
395 D N Greenwald Center Mukwonago Wisconsin United States 53149
396 Cancer Center of Western Wisconsin New Richmond Wisconsin United States 54017
397 Oconomowoc Memorial Hospital-ProHealth Care Inc Oconomowoc Wisconsin United States 53066-3896
398 Green Bay Oncology - Oconto Falls Oconto Falls Wisconsin United States 54154
399 Marshfield Clinic at James Beck Cancer Center Rhinelander Wisconsin United States 54501
400 Saint Mary's Hospital Rhinelander Wisconsin United States 54501
401 Marshfield Clinic-Rice Lake Center Rice Lake Wisconsin United States 54868
402 Saint Nicholas Hospital Sheboygan Wisconsin United States 53081
403 Marshfield Clinic Cancer Care at Saint Michael's Hospital Stevens Point Wisconsin United States 54481
404 Saint Michael's Hospital Stevens Point Wisconsin United States 54481
405 Green Bay Oncology - Sturgeon Bay Sturgeon Bay Wisconsin United States 54235
406 Waukesha Memorial Hospital - ProHealth Care Waukesha Wisconsin United States 53188
407 Aspirus Regional Cancer Center Wausau Wisconsin United States 54401
408 Marshfield Clinic-Wausau Center Wausau Wisconsin United States 54401
409 Diagnostic and Treatment Center Weston Wisconsin United States 54476
410 Marshfield Clinic - Weston Center Weston Wisconsin United States 54476
411 Saint Clare's Hospital Weston Wisconsin United States 54476
412 Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids Wisconsin United States 54494
413 Rocky Mountain Oncology Casper Wyoming United States 82609
414 Big Horn Basin Cancer Center Cody Wyoming United States 82414
415 Billings Clinic-Cody Cody Wyoming United States 82414
416 Welch Cancer Center Sheridan Wyoming United States 82801
417 The Moncton Hospital Moncton New Brunswick Canada E1C 6Z8
418 Allan Blair Cancer Centre Regina Saskatchewan Canada S4T 7T1

Sponsors and Collaborators

  • Eastern Cooperative Oncology Group
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Mitchell R. Smith, MD, PhD, Fox Chase Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT01415752
Other Study ID Numbers:
  • E1411
  • ECOG-E1411
  • NCI-2011-02980
  • CDR0000707057
First Posted:
Aug 12, 2011
Last Update Posted:
Aug 12, 2022
Last Verified:
Aug 1, 2022

Study Results

No Results Posted as of Aug 12, 2022