Rituximab, Bendamustine Hydrochloride, and Bortezomib Followed by Rituximab and Lenalidomide in Treating Older Patients With Previously Untreated Mantle Cell Lymphoma
NCT ID: NCT01415752
Last Updated: 2025-04-08
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE2
373 participants
INTERVENTIONAL
2012-08-09
2031-09-30
Brief Summary
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PURPOSE: This randomized phase II trial studies rituximab, bortezomib, bendamustine, and lenalidomide in treating previously untreated older patients with mantle cell lymphoma.
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Detailed Description
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Primary
* To determine whether the addition of bortezomib (RBV) to an induction regimen of rituximab-bendamustine (RB) improves progression-free survival (PFS) compared to RB alone in patients 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.
Laboratory
* 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).
Quality of Life
* 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.
Imaging
* 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.
Residual Disease Assessment by Molecular and 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Induction: (A) Bendamustine + Rituximab then Maintenance: (E) Rituximab
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 maintenance treatment.
Patients receive maintenance therapy comprising rituximab IV on day 1. Courses repeat every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
rituximab
Given IV
Bendamustine
Given IV
Induction: (B) Bendamustine + Rituximab + Bortezomib then Maintenance: (F) Rituximab
Patients receive induction therapy comprising rituximab IV on day 1, bendamustine hydrochloride IV over 60 minutes on days 1-2 and bortezomib IV subcutaneously (SC) on days 1 and 8. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to maintenance treatment.
Patients receive maintenance therapy comprising rituximab IV on day 1. Courses repeat every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
rituximab
Given IV
Bendamustine
Given IV
bortezomib
Given IV or SC
Induction: (C) Bendamustine + Rituximab then Maintenance: (G) Lenalidomide + Rituximab
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 maintenance treatment. Patients then proceed to maintenance treatment.
Patients receive maintenance 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.
rituximab
Given IV
Bendamustine
Given IV
lenalidomide
Given PO
Induction: (D) Bendamustine + Rituximab + Bortezomib then Maintenance: (H) Lenalidomide + Rituximab
Patients receive induction therapy comprising rituximab IV on day 1, bendamustine hydrochloride IV over 60 minutes on days 1-2 and bortezomib IV subcutaneously (SC) on days 1 and 8. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to maintenance treatment.
Patients receive maintenance 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.
rituximab
Given IV
Bendamustine
Given IV
bortezomib
Given IV or SC
lenalidomide
Given PO
Interventions
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rituximab
Given IV
Bendamustine
Given IV
bortezomib
Given IV or SC
lenalidomide
Given PO
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Negative pregnancy test
* Women of childbearing potential and sexually active males use an accepted and effective method of contraception
* ECOG performance status 0-2
* Absolute neutrophil count (ANC) ≥ 1,500/mcL (1.5 x 10\^9/L)
* Platelets ≥ 100,000/mcL (100 x 10\^9/L)
* Aspartate transaminase (AST)/alanine transaminase (ALT) ≤ 2 times upper limit of normal (ULN)
* Bilirubin ≤ 2 times ULN
* Calculated creatinine clearance by Cockroft-Gault formula ≥ 30 mL/min
* Patient agrees that if randomized to Arms C or D, and proceeding 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, DVT prophylaxis as all patients registering to the lenalidomide/rituximab Arms G and H will be required to have deep vein thrombosis (DVT) prophylaxis. Patients randomized to Arms G or H who have a history of a thrombotic vascular event will be required to have full anticoagulation, therapeutic doses of low molecular weight heparin or warfarin to maintain an INR between 2.0 - 3.0, or any other accepted full anticoagulation regimen (e.g. direct thrombin inhibitors or Factor Xa inhibitors) with appropriate monitoring for that agent. 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 or another accepted full anticoagulation regimen. Ways to minimize risk of DVT should be discussed with patients, including, but not limited to, avoiding smoking, minimizing prothrombotic hormone replacement, avoiding prolonged periods of inactivity (e.g. uninterrupted long car or plane trips).
* 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
* CD4 count at screening \>= 300 cells/mm³
* 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
* ECOG performance status between 0-2
* Complete response, partial response or stable disease after Step 1
* ANC \>= 1000 cells/mm3 (1.0 x 10\^9/L)
* Platelets \>= 75,000 cells/mm3 (75 x 10\^9/L)
* AST/ALT \<= 2 x upper limit of normal (ULN)
* Total bilirubin \<= 2 x upper limit of normal (ULN) or, if total elevated, direct bilirubin \<= 2 x upper limit of normal (ULN)
* Calculated creatinine clearance by Cockroft-Gault formula \>= 30 ml/min
* Patient agrees that if randomized to Arms C or D, and proceeding onto Arms G or H, they must register into the mandatory REMS program, and be willing and able to comply with the requirements of REMS.
* Pregnancy tests must occur within 10 - 14 days and again within 24 hours prior to initiation of Cycle 1 of lenalidomide.
* Females of childbearing potential (FCBP)\* with regular or no menstruation must have a pregnancy test weekly for the first 28 days and then every 28 days while on lenalidomide therapy (including breaks in therapy); at discontinuation of lenalidomide and at Day 28 post the last dose of lenalidomide. Females with irregular menstruation must have a pregnancy test weekly for the first 28 days and then every 14 days while on lenalidomide therapy (including breaks in therapy), at discontinuation of lenalidomide and at Day 14 and Day 28 post the last dose of lenalidomide (see Appendix VI: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods).
* Females of childbearing potential (FCBP)\* must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 - 14 days and again within 24 hours prior to starting Cycle 1 of lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP 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.
* A female of childbearing potential is any sexually mature female, regardless of sexual orientation of whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
* Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study/lenaliomide: 1) for at least 28 days before starting lenalidomide; 2) while participating in the study including interruptions in therapy; and 3) for at least 28 days after discontinuation/stopping lenalidomide. The two methods of reliable contraception must include one highly effective method (i.e. intrauterine device (IUD), hormonal \[birth control pills, injections, or implants\], tubal ligation, partner's vasectomy) and one additional effective (barrier) method (i.e. latex condom, diaphragm, cervical cap). FCBP must be referred to a qualified provider of contraceptive methods if needed.
* 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. All males, regardless of whether they have undergone a successful vasectomy, must agree to use a latex condom during sexual contact with a female of childbearing potential, or to practice complete abstinence from heterosexual intercourse with any female of childbearing potential during all cycles of study treatment and for at least 28 days following discontinuation of protocol treatment
* Patients must have no medical contra-indications to, and be willing to take, DVT prophylaxis as all patients registering to the lenalidomide/rituximab Arms G and H will be required to have deep vein thrombosis (DVT) prophylaxis. Patients randomized to Arms G or H who have full anticoagulation, 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, or any other accepted full anticoagulation regimen (e.g. direct thrombin inhibitors or Factor Xa inhibitors) with appropriate monitoring for that agent. 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 or another accepted full anticoagulation regimen. Ways to minimize risk of DVT should be discussed with patients, including, but not limited to, avoiding smoking, minimizing pro-thrombotic hormone replacement, avoiding prolonged periods of inactivity (e.g. uninterrupted long car or plane trips).
Exclusion Criteria
* Evidence of prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical carcinoma, low grade prostate carcinoma (Gleason grade ≤ 6) managed with observation that has been stable for at least 6 months, or any malignancy treated with curative intent continuously disease free for \>=3 years so as not to interfere with interpretation of radiographic response
* Prior therapy for MCL, except: \< 2 weeks of steroid therapy for symptom control or local radiation therapy for symptom control if there is measurable disease outside the radiation portal. Patients may be on chronic steroids for non-malignant disease if on a stable dose equivalent to ≤ 20 mg prednisone per day.
* CNS involvement
* History of AIDS-defining conditions
* Grade 2 or greater peripheral neuropathy.
* NYHA Class III or IV heart failure, uncontrolled angina severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia
* Hypersensitivity to bortezomib, boron or mannitol
* A serious medical or psychiatric illness likely to interfere with study participation
* Participating in any other therapeutic clinical trial or taking any other experimental medications within 14 days prior to registration.
18 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Eastern Cooperative Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Mitchell R. Smith, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Fox Chase Cancer Center
Locations
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Eastern Maine Medical Center
Bangor, Maine, United States
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, United States
Alaska Women's Cancer Care
Anchorage, Alaska, United States
Anchorage Oncology Centre
Anchorage, Alaska, United States
Katmai Oncology Group
Anchorage, Alaska, United States
Providence Alaska Medical Center
Anchorage, Alaska, United States
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, United States
Kaiser Permanente, Fremont
Fremont, California, United States
Kaiser Permanente
Fresno, California, United States
Los Angeles County-USC Medical Center
Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Kaiser Permanente-Modesto
Modesto, California, United States
Kaiser Permanente-Oakland
Oakland, California, United States
Kaiser Permanente-Redwood City
Redwood City, California, United States
Kaiser Permanente-Richmond
Richmond, California, United States
Kaiser Permanente-Roseville
Roseville, California, United States
Kaiser Permanente-South Sacramento
Sacramento, California, United States
Kaiser Permanente - Sacramento
Sacramento, California, United States
Kaiser Permanente-San Francisco
San Francisco, California, United States
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, United States
Kaiser Permanente San Leandro
San Leandro, California, United States
Kaiser Permanente-San Rafael
San Rafael, California, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States
Kaiser Permanente-Santa Rosa
Santa Rosa, California, United States
Kaiser Permanente-South San Francisco
South San Francisco, California, United States
Stanford University Hospitals and Clinics
Stanford, California, United States
Kaiser Permanente-Stockton
Stockton, California, United States
Kaiser Permanente Medical Center-Vacaville
Vacaville, California, United States
Kaiser Permanente-Vallejo
Vallejo, California, United States
Kaiser Permanente-Walnut Creek
Walnut Creek, California, United States
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, United States
The Medical Center of Aurora
Aurora, Colorado, United States
Boulder Community Hospital
Boulder, Colorado, United States
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, United States
Kaiser Permanente-Franklin
Denver, Colorado, United States
Porter Adventist Hospital
Denver, Colorado, United States
Exempla Saint Joseph Hospital
Denver, Colorado, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, United States
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado, United States
Rocky Mountain Cancer Centers-Rose
Denver, Colorado, United States
Rose Medical Center
Denver, Colorado, United States
Colorado Cancer Research Program CCOP
Denver, Colorado, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Mercy Medical Center
Durango, Colorado, United States
Southwest Oncology PC
Durango, Colorado, United States
Comprehensive Cancer Care and Research Institute of Colorado LLC
Englewood, Colorado, United States
Swedish Medical Center
Englewood, Colorado, United States
Poudre Valley Hospital
Fort Collins, Colorado, United States
Mountain Blue Cancer Care Center
Golden, Colorado, United States
North Colorado Medical Center
Greeley, Colorado, United States
Rocky Mountain Cancer Centers-Greenwood Village
Greenwood Village, Colorado, United States
Kaiser Permanente-Rock Creek
Lafayette, Colorado, United States
Rocky Mountain Cancer Centers-Lakewood
Lakewood, Colorado, United States
Saint Anthony Hospital
Lakewood, Colorado, United States
Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado, United States
Littleton Adventist Hospital
Littleton, Colorado, United States
Kaiser Permanente-Lone Tree
Lone Tree, Colorado, United States
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado, United States
Sky Ridge Medical Center
Lone Tree, Colorado, United States
Longmont United Hospital
Longmont, Colorado, United States
Rocky Mountain Cancer Centers-Longmont
Longmont, Colorado, United States
McKee Medical Center
Loveland, Colorado, United States
Parker Adventist Hospital
Parker, Colorado, United States
Rocky Mountain Cancer Centers-Parker
Parker, Colorado, United States
Saint Mary Corwin Medical Center
Pueblo, Colorado, United States
Rocky Mountain Cancer Centers - Pueblo
Pueblo, Colorado, United States
Rocky Mountain Cancer Centers-Thornton
Thornton, Colorado, United States
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, United States
Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States
Beebe Medical Center
Lewes, Delaware, United States
Christiana Gynecologic Oncology LLC
Newark, Delaware, United States
Delaware Clinical and Laboratory Physicians PA
Newark, Delaware, United States
Helen F Graham Cancer Center
Newark, Delaware, United States
Medical Oncology Hematology Consultants PA
Newark, Delaware, United States
Regional Hematology and Oncology PA
Newark, Delaware, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States
Beebe Health Campus
Rehoboth Beach, Delaware, United States
Nanticoke Memorial Hospital
Seaford, Delaware, United States
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware, United States
Lombardi Comprehensive Cancer Center at Georgetown University
Washington D.C., District of Columbia, United States
Baptist Cancer Institute
Jacksonville, Florida, United States
UF Cancer Center at Orlando Health
Orlando, Florida, United States
Oncare Hawaii Inc-POB II
Honolulu, Hawaii, United States
Queen's Medical Center
Honolulu, Hawaii, United States
Straub Clinic and Hospital
Honolulu, Hawaii, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, United States
OnCare Hawaii-Liliha
Honolulu, Hawaii, United States
Oncare Hawaii Inc-Kuakini
Honolulu, Hawaii, United States
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States
Castle Medical Center
Kailua, Hawaii, United States
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, United States
Oncare Hawaii Inc-Pali Momi
‘Aiea, Hawaii, United States
Pali Momi Medical Center
‘Aiea, Hawaii, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States
Idaho Urologic Institute-Meridian
Meridian, Idaho, United States
Kootenai Cancer Center
Post Falls, Idaho, United States
Kootenai Cancer
Sandpoint, Idaho, United States
Memorial Hospital of Carbondale
Carbondale, Illinois, United States
Centralia Oncology Clinic
Centralia, Illinois, United States
Mount Sinai Hospital Medical Center
Chicago, Illinois, United States
Hematology and Oncology Associates
Chicago, Illinois, United States
Northwestern University
Chicago, Illinois, United States
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, United States
Carle on Vermilion
Danville, Illinois, United States
Cancer Care Center of Decatur
Decatur, Illinois, United States
Decatur Memorial Hospital
Decatur, Illinois, United States
Carle Physician Group-Effingham
Effingham, Illinois, United States
Crossroads Cancer Center
Effingham, Illinois, United States
Hematology Oncology Associates of Illinois-Highland Park
Highland Park, Illinois, United States
Presence Saint Mary's Hospital
Kankakee, Illinois, United States
North Shore Hematology Oncology
Libertyville, Illinois, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, United States
Illinois Cancer Specialists-Niles
Niles, Illinois, United States
SwedishAmerican Regional Cancer Center/ACT
Rockford, Illinois, United States
Hematology Oncology Associates of Illinois - Skokie
Skokie, Illinois, United States
Memorial Medical Center
Springfield, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
The Carle Foundation Hospital
Urbana, Illinois, United States
IU Health Arnett Cancer Care
Lafayette, Indiana, United States
Franciscan Saint Anthony Health-Michigan City
Michigan City, Indiana, United States
Woodland Cancer Care Center
Michigan City, Indiana, United States
Reid Hospital and Health Care Services
Richmond, Indiana, United States
Mary Greeley Medical Center
Ames, Iowa, United States
McFarland Clinic PC-William R Bliss Cancer Center
Ames, Iowa, United States
Hematology Oncology Associates-Quad Cities
Bettendorf, Iowa, United States
McFarland Clinic PC-Boone
Boone, Iowa, United States
Cedar Rapids Oncology Association
Cedar Rapids, Iowa, United States
Mercy Hospital
Cedar Rapids, Iowa, United States
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, United States
McFarland Clinic PC-Trinity Cancer Center
Fort Dodge, Iowa, United States
McFarland Clinic PC-Jefferson
Jefferson, Iowa, United States
McFarland Clinic PC-Marshalltown
Marshalltown, Iowa, United States
Siouxland Hematology Oncology Associates
Sioux City, Iowa, United States
Mercy Medical Center-Sioux City
Sioux City, Iowa, United States
Saint Luke's Regional Medical Center
Sioux City, Iowa, United States
Lawrence Memorial Hospital
Lawrence, Kansas, United States
Menorah Medical Center
Overland Park, Kansas, United States
Saint Luke's South Hospital
Overland Park, Kansas, United States
Kansas City CCOP
Prairie Village, Kansas, United States
Wesley Medical Center
Wichita, Kansas, United States
Oncology Hematology Care Inc-Crestview
Crestview Hills, Kentucky, United States
Ochsner Health Center-Summa
Baton Rouge, Louisiana, United States
Ochsner Baptist Medical Center
New Orleans, Louisiana, United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana, United States
Harold Alfond Center for Cancer Care
Augusta, Maine, United States
Penobscot Bay Medical Center
Rockport, Maine, United States
Franklin Square Hospital Center
Baltimore, Maryland, United States
Union Hospital of Cecil County
Elkton, Maryland, United States
Holy Cross Hospital
Silver Spring, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Simonds-Sinon Regional Cancer Center
Fitchburg, Massachusetts, United States
Baystate Medical Center
Springfield, Massachusetts, United States
University of Massachusetts Medical School
Worcester, Massachusetts, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States
Michigan Cancer Research Consortium Community Clinical Oncology Program
Ann Arbor, Michigan, United States
Bronson Battle Creek
Battle Creek, Michigan, United States
Spectrum Health Big Rapids Hospital
Big Rapids, Michigan, United States
Oakwood Hospital and Medical Center
Dearborn, Michigan, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States
Saint John Hospital and Medical Center
Detroit, Michigan, United States
Green Bay Oncology - Escanaba
Escanaba, Michigan, United States
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
Genesys Hurley Cancer Institute
Flint, Michigan, United States
Genesys Regional Medical Center
Grand Blanc, Michigan, United States
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States
Mercy Health Saint Mary's
Grand Rapids, Michigan, United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States
Green Bay Oncology - Iron Mountain
Iron Mountain, Michigan, United States
Allegiance Health
Jackson, Michigan, United States
Borgess Medical Center
Kalamazoo, Michigan, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Sparrow Hospital
Lansing, Michigan, United States
Saint Mary Mercy Hospital
Livonia, Michigan, United States
Mercy Health Mercy Campus
Muskegon, Michigan, United States
Lakeland Community Hospital
Niles, Michigan, United States
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States
Saint Joseph Mercy Port Huron
Port Huron, Michigan, United States
Spectrum Health Reed City Hospital
Reed City, Michigan, United States
Saint Mary's of Michigan
Saginaw, Michigan, United States
Lakeland Hospital
Saint Joseph, Michigan, United States
Marie Yeager Cancer Center
Saint Joseph, Michigan, United States
Munson Medical Center
Traverse City, Michigan, United States
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States
Sanford Clinic North-Bemidgi
Bemidji, Minnesota, United States
Fairview Ridges Hospital
Burnsville, Minnesota, United States
Mercy Hospital
Coon Rapids, Minnesota, United States
Essentia Health Cancer Center
Duluth, Minnesota, United States
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, United States
Miller-Dwan Hospital
Duluth, Minnesota, United States
Fairview-Southdale Hospital
Edina, Minnesota, United States
Unity Hospital
Fridley, Minnesota, United States
Hutchinson Area Health Care
Hutchinson, Minnesota, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
Health Partners Inc
Minneapolis, Minnesota, United States
New Ulm Medical Center
New Ulm, Minnesota, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Metro-Minnesota CCOP
Saint Louis Park, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
United Hospital
Saint Paul, Minnesota, United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, United States
Lakeview Hospital
Stillwater, Minnesota, United States
Ridgeview Medical Center
Waconia, Minnesota, United States
Rice Memorial Hospital
Willmar, Minnesota, United States
Minnesota Oncology and Hematology PA-Woodbury
Woodbury, Minnesota, United States
Parkland Health Center-Bonne Terre
Bonne Terre, Missouri, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, United States
Southeast Cancer Center
Cape Girardeau, Missouri, United States
University of Missouri - Ellis Fischel
Columbia, Missouri, United States
Centerpoint Medical Center LLC
Independence, Missouri, United States
Capital Region Medical Center-Goldschmidt Cancer Center
Jefferson City, Missouri, United States
Freeman Health System
Joplin, Missouri, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Heartland Hematology and Oncology Associates Incorporated
Kansas City, Missouri, United States
Research Medical Center
Kansas City, Missouri, United States
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, United States
Liberty Radiation Oncology Center
Liberty, Missouri, United States
Phelps County Regional Medical Center
Rolla, Missouri, United States
Saint John's Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, United States
Mercy Hospital Springfield
Springfield, Missouri, United States
Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield
Springfield, Missouri, United States
CoxHealth South Hospital
Springfield, Missouri, United States
Saint Louis Cancer and Breast Institute-South City
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Missouri Baptist Medical Center
St Louis, Missouri, United States
Comprehensive Cancer Care PC
St Louis, Missouri, United States
Saint John's Mercy Medical Center
St Louis, Missouri, United States
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, United States
Missouri Baptist Outpatient Center-Sunset Hills
Sunset Hills, Missouri, United States
Montana Cancer Consortium CCOP
Billings, Montana, United States
Saint Vincent Healthcare
Billings, Montana, United States
Frontier Cancer Center and Blood Institute-Billings
Billings, Montana, United States
Billings Clinic Cancer Center
Billings, Montana, United States
Bozeman Deaconess Hospital
Bozeman, Montana, United States
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, United States
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, United States
Great Falls Clinic
Great Falls, Montana, United States
Northern Montana Hospital
Havre, Montana, United States
Saint Peter's Community Hospital
Helena, Montana, United States
Glacier Oncology PLLC
Kalispell, Montana, United States
Kalispell Medical Oncology
Kalispell, Montana, United States
Kalispell Regional Medical Center
Kalispell, Montana, United States
Community Medical Hospital
Missoula, Montana, United States
Montana Cancer Specialists
Missoula, Montana, United States
Saint Patrick Hospital - Community Hospital
Missoula, Montana, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Norris Cotton Cancer Center Nashua
Nashua, New Hampshire, United States
Cooper Hospital University Medical Center
Camden, New Jersey, United States
Veterans Adminstration New Jersey Health Care System
East Orange, New Jersey, United States
Hematology Oncology Associates of Central New York-Auburn
Auburn, New York, United States
Hematology Oncology Associates of Central New York-East Syracuse
East Syracuse, New York, United States
Glens Falls Hospital
Glens Falls, New York, United States
Hematology Oncology Associates of Central New York-Liverpool
Liverpool, New York, United States
Orange Regional Medical Center
Middletown, New York, United States
Mount Sinai Medical Center
New York, New York, United States
Weill Medical College of Cornell University
New York, New York, United States
University of Rochester
Rochester, New York, United States
Hematology Oncology Associates of Central New York-Rome
Rome, New York, United States
Hematology Oncology Associates of Central New York-Onondaga Hill
Syracuse, New York, United States
Albert Einstein College of Medicine
The Bronx, New York, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina, United States
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina, United States
Wayne Memorial Hospital
Goldsboro, North Carolina, United States
Hendersonville Hematology and Oncology at Pardee
Hendersonville, North Carolina, United States
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, United States
Park Ridge Hospital Breast Health Center
Hendersonville, North Carolina, United States
Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina, United States
Kinston Medical Specialists PA
Kinston, North Carolina, United States
Iredell Memorial Hospital
Statesville, North Carolina, United States
Southeastern Medical Oncology Center-Wilson
Wilson, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Roger Maris Cancer Center
Fargo, North Dakota, United States
Sanford Clinic North-Fargo
Fargo, North Dakota, United States
Sanford Medical Center-Fargo
Fargo, North Dakota, United States
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, United States
Summa Barberton Hospital
Barberton, Ohio, United States
Cleveland Clinic Cancer Center Beachwood
Beachwood, Ohio, United States
Oncology Hematology Care Inc-Mercy West
Cincinnati, Ohio, United States
Oncology and Hematology Care Inc-Taft
Cincinnati, Ohio, United States
Oncology Hematology Care Inc - Anderson
Cincinnati, Ohio, United States
Oncology Hematology Care Inc - Kenwood
Cincinnati, Ohio, United States
Oncology Hematology Care Inc-Blue Ash
Cincinnati, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
Case Western Reserve University
Cleveland, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States
Grandview Hospital
Dayton, Ohio, United States
Good Samaritan Hospital - Dayton
Dayton, Ohio, United States
Miami Valley Hospital
Dayton, Ohio, United States
Samaritan North Health Center
Dayton, Ohio, United States
Dayton CCOP
Dayton, Ohio, United States
Mercy Cancer Center-Elyria
Elyria, Ohio, United States
Oncology Hematology Care Inc-Healthplex
Fairfield, Ohio, United States
Blanchard Valley Hospital
Findlay, Ohio, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, United States
Wayne Hospital
Greenville, Ohio, United States
Cleveland Clinic Cancer Center Independence
Independence, Ohio, United States
Kettering Medical Center
Kettering, Ohio, United States
Cleveland Clinic Cancer Center Mansfield
Mansfield, Ohio, United States
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, United States
Lake University Ireland Cancer Center
Mentor, Ohio, United States
North Coast Cancer Care
Sandusky, Ohio, United States
Cleveland Clinic Cancer Center Strongsville
Strongsville, Ohio, United States
Upper Valley Medical Center
Troy, Ohio, United States
South Pointe Hospital
Warrensville Heights, Ohio, United States
University Pointe
West Chester, Ohio, United States
UH-Seidman Cancer Center at Saint John Medical Center
Westlake, Ohio, United States
Cleveland Clinic Wooster Specialty Center
Wooster, Ohio, United States
Greene Memorial Hospital
Xenia, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Tulsa Cancer Institute
Tulsa, Oklahoma, United States
Clackamas Radiation Oncology Center
Clackamas, Oregon, United States
Providence Milwaukie Hospital
Milwaukie, Oregon, United States
Providence Newberg Medical Center
Newberg, Oregon, United States
Providence Willamette Falls Medical Center
Oregon City, Oregon, United States
Providence Portland Medical Center
Portland, Oregon, United States
Western Oncology Research Consortium
Portland, Oregon, United States
Providence Saint Vincent Medical Center
Portland, Oregon, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, United States
Geisinger Medical Oncology at Evangelical Community Hospital
Lewisburg, Pennsylvania, United States
Lewistown Hospital
Lewistown, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Pottstown Memorial Medical Center
Pottstown, Pennsylvania, United States
Geisinger Medical Oncology-Pottsville
Pottsville, Pennsylvania, United States
Geisinger Medical Group
State College, Pennsylvania, United States
Mount Nittany Medical Center
State College, Pennsylvania, United States
Reading Hospital
West Reading, Pennsylvania, United States
Geisinger Wyoming Valley
Wilkes-Barre, Pennsylvania, United States
AnMed Health Cancer Center
Anderson, South Carolina, United States
Saint Francis Hospital
Greenville, South Carolina, United States
Gibbs Cancer Center-Pelham
Greer, South Carolina, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
Upstate Carolina CCOP
Spartanburg, South Carolina, United States
Wellmont Bristol Regional Medical Center
Bristol, Tennessee, United States
Wellmont Medical Associates Oncology and Hematology-Bristol
Bristol, Tennessee, United States
Wellmont Holston Valley Hospital and Medical Center
Kingsport, Tennessee, United States
Wellmont Medical Associates Oncology and Hematology-Kingsport
Kingsport, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Parkland Memorial Hospital
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Memorial Hospital Of Martinsville
Martinsville, Virginia, United States
Southwest VA Regional Cancer Center
Norton, Virginia, United States
Massey Cancer Center at Virginia Commonwealth University
Richmond, Virginia, United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, United States
EvergreenHealth Medical Center
Kirkland, Washington, United States
Seattle Cancer Care Alliance at EvergreenHealth
Kirkland, Washington, United States
Saint John Medical Center
Longview, Washington, United States
Skagit Valley Hospital Regional Cancer Care Center
Mount Vernon, Washington, United States
Skagit Valley Hospital
Mount Vernon, Washington, United States
Olympic Medical Center
Port Angeles, Washington, United States
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
Olympic Medical Cancer Care Center
Sequim, Washington, United States
Cancer Care Northwest - Spokane South
Spokane, Washington, United States
Cancer Care Northwest-Valley
Spokane, Washington, United States
Cancer Care Northwest-North Spokane
Spokane, Washington, United States
PeaceHealth Southwest Medical Center
Vancouver, Washington, United States
Compass Oncology Vancouver
Vancouver, Washington, United States
Wenatchee Valley Hospital and Clinics
Wenatchee, Washington, United States
West Virginia University Healthcare
Morgantown, West Virginia, United States
Langlade Hospital and Cancer Center
Antigo, Wisconsin, United States
Marshfield Clinic Cancer Center at Sacred Heart
Eau Claire, Wisconsin, United States
Sacred Heart Hospital
Eau Claire, Wisconsin, United States
Agnesian Cancer Center
Fond du Lac, Wisconsin, United States
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, United States
Saint Vincent Hospital
Green Bay, Wisconsin, United States
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin, United States
Saint Mary's Hospital
Green Bay, Wisconsin, United States
UW Cancer Center Johnson Creek
Johnson Creek, Wisconsin, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Holy Family Memorial Hospital
Manitowoc, Wisconsin, United States
Bay Area Medical Center
Marinette, Wisconsin, United States
Marshfield Clinic
Marshfield, Wisconsin, United States
Saint Joseph's Hospital
Marshfield, Wisconsin, United States
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, United States
D N Greenwald Center
Mukwonago, Wisconsin, United States
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, United States
Oconomowoc Memorial Hospital-ProHealth Care Inc
Oconomowoc, Wisconsin, United States
Green Bay Oncology - Oconto Falls
Oconto Falls, Wisconsin, United States
Marshfield Clinic at James Beck Cancer Center
Rhinelander, Wisconsin, United States
Saint Mary's Hospital
Rhinelander, Wisconsin, United States
Marshfield Clinic-Rice Lake Center
Rice Lake, Wisconsin, United States
Saint Nicholas Hospital
Sheboygan, Wisconsin, United States
Marshfield Clinic Cancer Care at Saint Michael's Hospital
Stevens Point, Wisconsin, United States
Saint Michael's Hospital
Stevens Point, Wisconsin, United States
Green Bay Oncology - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States
Waukesha Memorial Hospital - ProHealth Care
Waukesha, Wisconsin, United States
Aspirus Regional Cancer Center
Wausau, Wisconsin, United States
Marshfield Clinic-Wausau Center
Wausau, Wisconsin, United States
Diagnostic and Treatment Center
Weston, Wisconsin, United States
Marshfield Clinic - Weston Center
Weston, Wisconsin, United States
Saint Clare's Hospital
Weston, Wisconsin, United States
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, United States
Rocky Mountain Oncology
Casper, Wyoming, United States
Big Horn Basin Cancer Center
Cody, Wyoming, United States
Billings Clinic-Cody
Cody, Wyoming, United States
Welch Cancer Center
Sheridan, Wyoming, United States
The Moncton Hospital
Moncton, New Brunswick, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada
Countries
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References
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Smith MR, Jegede OA, Martin P, Till BG, Parekh SS, Yang DT, Hsi ED, Witzig T, Dave S, Scott D, Hanson C, Kostakoglu Shields L, Abdel-Samad N, Casulo C, Bartlett NL, Caimi PF, Al Baghdadi T, Blum KA, Romer MD, Inwards DJ, Lerner RE, Wagner LI, Little RF, Friedberg JW, Leonard JP, Kahl BS. Randomized study of induction with bendamustine-rituximab +/- bortezomib and maintenance with rituximab +/- lenalidomide for MCL. Blood. 2024 Sep 5;144(10):1083-1092. doi: 10.1182/blood.2024023962.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NCI-2011-02980
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000707057
Identifier Type: OTHER
Identifier Source: secondary_id
E1411
Identifier Type: -
Identifier Source: org_study_id
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