Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML), or Low-Blast Acute Myelogenous Leukemia (AML)

IDENTIFIERS
Trial Protocol: Pevonedistat-3001
Clinicaltrials.gov: NCT03268954
JapicCTI: JapicCTI-183848
EudraCT: 2017-000318-40
PURPOSE

The purpose of this study is to determine whether the combination of pevonedistat and azacitidine improves event-free survival (EFS) when compared with single-agent azacitidine. (An event is defined as death or transformation to AML in participants with MDS or CMML, whichever occurs first, and is defined as death in participants with low-blast AML).

Recruitment Complete
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Trial at a glance

What medical condition is being studied?   Leukemia
What is the trial testing?   Azacitidine, Pevonedistat
How many participants are being enrolled?   472
When is the trial being conducted?    - 

Key requirements

Sex   
All
Age   
From 18 Years
Accepts Healthy Volunteers?   
No

Trial Details / Participation Requirements

CLICK TO EXPANDCLICK TO COLLAPSE
Trial Phase:   Phase 3
Trial Type:   Interventional
Trial Arms/Groups or Cohorts:   
Azacitidine + Pevonedistat: Azacitidine 75 milligram per square meter (mg/m^2), intravenous or subcutaneous, on Days 1 to 5, Days 8 and 9 and pevonedistat 20 mg/m^2, 60-minute (+/-10) infusion, intravenous, on Days 1, 3, and 5 in 28-day treatment cycles until disease progression or unacceptable toxicity.
Azacitidine: Azacitidine 75 mg/m^2, intravenous or subcutaneous, on Days 1 to 5, Days 8 and 9 in 28-day treatment cycles until disease progression or unacceptable toxicity.
Intervention:   Azacitidine, Pevonedistat
Primary Outcome Measure(s):
Event-Free Survival (EFS) [Time Frame: From randomization until transformation to acute myeloid leukemia, or death due to any cause : up to 6 years]
Secondary Outcome Measure(s):   
Overall Survival (OS) [Time Frame: From randomization until death : up to 6 years]
Six-Month Survival Rate [Time Frame: Month 6]
One-Year Survival Rate [Time Frame: Month 12]
Thirty-Day Survival Rate [Time Frame: Day 30]
Sixty-Day Survival Rate [Time Frame: Day 60]
Time to AML Transformation in HR MDS and CMML Participants [Time Frame: From randomization until transformation to AML : up to 6 years]
Percentage of Participants with complete remission (CR) and complete remission with incomplete blood count recovery (CRi) [Time Frame: From randomization until CR and CRi : up to 6 years]
Percentage of Participants with CR and Marrow CR [Time Frame: From randomization until CR or marrow CR : up to 6 years]
Percentage of Participants with CR, partial remission (PR) and Hematologic Improvement (HI) [Time Frame: From randomization until, CR, PR or HI : up to 6 years]
Percentage of Participants with CR and Marrow CR and PR [Time Frame: From randomization until CR or Marrow CR and PR : up to 6 years]
Percentage of Participants with CR and Marrow CR, PR and Hematologic Improvement (HI) [Time Frame: From randomization until CR, marrow CR, PR or HI : up to 6 years]
Percentage of Participants with Overall Response (OR) [Time Frame: From randomization until CR and PR or CR, CRi and PR : up to 6 years]
Percentage of Participants with Overall Response 2 (OR2) [Time Frame: From randomization until, CR, PR or HI or CR, CRi or PR : up to 6 years]
Duration of CR [Time Frame: From CR until first documentation of PD or relapse from CR or relapse after CR or PR : up to 6 years]
Duration of Overall Response (OR) [Time Frame: From CR or PR or CR, CRi or PR to the first documented PD or relapse from CR (in participants with low-blast AML) or relapse after CR or PR (in participants with HR MDS/CMML): up to 6 years]
Duration of Overall Response 2 (OR2) [Time Frame: From documented CR, PR or HI to the first documented PD or relapse from CR (in participants with low-blast AML) or relapse after CR or PR (in participants with HR MDS/CMML): up to 6 years]
Percentage of Participants with Red Blood Cells (RBCs) and Platelet-transfusion Independence [Time Frame: 8 weeks before the first dose of study drug through 30 days after last dose of any study drug : up to 6 years]
Duration of Red Blood Cells (RBCs) and Platelet-transfusion Independence [Time Frame: 8 weeks before the first dose of study drug through 30 days after last dose of any study drug : up to 6 years]
Time to First CR or PR [Time Frame: From randomization until CR or PR : up to 6 years]
Percentage of Participants with Hematologic Improvement (HI) [Time Frame: From randomization until HI : up to 6 years]
Percentage of Participants with at least 1 Inpatient Hospital Admissions Related to HR MDS, CMML or Low-blast AML [Time Frame: From randomization until transformation to AML or until initiation of subsequent therapy up to approximately up to 6 years]
Time to Progressive Disease (PD), Relapse after CR (Low-blast AML), Relapse After CR or PR (HR MDS/CMML), or Death [Time Frame: From randomization until PD, relapse after CR, or relapse after CR or PR, or death due to any cause, whichever occurs first (up to 6 years)]
Health-Related Quality of Life (HRQOL) using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire- Core 30 [Time Frame: Baseline Up to 6 years]
Plasma Concentration of Pevonedistat [Time Frame: Cycle 1 Day 1 predose and multiple time points (up to 4 hours) post dose; Cycle 1 Days 3 and 5 predose; Cycle 2 and 4 Day 1 at multiple time points (up to 3 hours) post dose; Cycle 4 Day 3 predose]
Percentage of Participants with Overall Response in Participants who have TP53 Mutations, 17p Deletions, and/or are Determined to be in an Adverse Cytogenetic Risk Group [Time Frame: From randomization until CR, CRi and PR : up to 6 years]
Event-Free Survival in Participants who have TP53 Mutations, 17p Deletions, and/or are Determined to be in an Adverse Cytogenetic Risk Group [Time Frame: From randomization until transformation to AML if eligible or death : up to 6 years]
Overall Survival in Participants who have TP53 Mutations, 17p Deletions, and/or are Determined to be in an Adverse Cytogenetic Risk Group [Time Frame: From randomization until death : up to 6 years]
Percentage of Participants with Overall Response by Cycle 6 [Time Frame: Up to Cycle 6 (up to approximately Day 168)]
Entry Criteria:
Inclusion Criteria: 1. Has morphologically confirmed diagnosis of myelodysplastic syndromes (MDS) or CMML (i.e., with white blood cell [WBC] <13,000/microliter [mcL]) or low-blast acute myelogenous leukemia (AML). 2. Has MDS or CMML and must also have one of the following Prognostic Risk Categories, based on the Revised International Prognostic Scoring System (IPSS-R): - Very high (>6 points). - High (>4.5-6 points). - Intermediate (>3-4.5 points): a participant determined to be in the Intermediate Prognostic Risk Category is only allowable in the setting of >=5% bone marrow myeloblasts. 3. Eastern Cooperative Oncology Group (ECOG) status of 0, 1, or 2. 4. Participants with AML (20%-30% blasts) must have a treatment-related mortality (TRM) score >=4 for intensive, induction chemotherapy as calculated using the simplified model described by Walter and coworkers. Calculation of TRM score: - 0 for (age <61 years), +2 for (age 61-70 years), +4 for (age >=71 years). - + 0 for (PS=0), +2 for (PS=1), +4 for (PS >1). - + 0 for (platelets <50), +1 for (platelets >=50). Exclusion Criteria: 1. Has previous treatment for HR MDS or CMML or low-blast AML with chemotherapy or other antineoplastic agents including hypomethylating agent (HMAs) such as decitabine or azacitidine. Previous treatment is permitted with hydroxyurea and with lenalidomide, except that lenalidomide may not be given within 8 weeks before the first dose of study drug. 2. Has acute promyelocytic leukemia as diagnosed by morphologic examination of bone marrow, by fluorescent in situ hybridization or cytogenetics of peripheral blood or bone marrow, or by other accepted analysis. 3. Participants with AML with a WBC count >50,000/mcL. Participants who are cytoreduced with leukapheresis or with hydroxyurea may be enrolled if they meet the eligibility criteria. 4. Is eligible for intensive chemotherapy and/or allogeneic stem cell transplantation. The reason a participant is not eligible for intensive chemotherapy and/or allogeneic stem cell transplantation may consist of one or more of the following factors: - Age >75. - Comorbidities. - Inability to tolerate intensive chemotherapy (e.g., participants with AML with 20%-30% blasts and TRM >=4). - Physician decision (e.g., lack of available stem cell donor). - The reason a participant is not eligible should be documented in the electronic case report form (eCRF). 5. Has either clinical evidence of or history of central nervous system involvement by AML. 6. Has active uncontrolled infection or severe infectious disease, such as severe pneumonia, meningitis, or septicemia. 7. Is diagnosed or treated for another malignancy within 2 years before randomization or previously diagnosed with another malignancy and have any evidence of residual disease. 8. Has nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone resection. 9. Has prothrombin time (PT) or aPTT >1.5× upper limit of normal (ULN) or active uncontrolled coagulopathy or bleeding disorder. Participants therapeutically anticoagulated with warfarin, direct thrombin inhibitors, direct factor Xa inhibitors, or heparin are excluded from enrollment. 10. Has known human immunodeficiency virus (HIV) seropositive. 11. Has known hepatitis B surface antigen seropositive, or known or suspected active hepatitis C infection. Note: Participants who have isolated positive hepatitis B core antibody (i.e., in the setting of negative hepatitis B surface antigen and negative hepatitis B surface antibody) must have an undetectable hepatitis B viral load. 12. Has known hepatic cirrhosis or severe preexisting hepatic impairment. 13. Has known cardiopulmonary disease defined as unstable angina, clinically significant arrhythmia, congestive heart failure (New York Heart Association Class III or IV), and/or myocardial infarction within 6 months before first dose, or severe pulmonary hypertension. 14. Has treatment with strong cytochrome P 3A (CYP3A) inducers within 14 days before the first dose of pevonedistat.

Trial Locations

Any
Active, not recruiting
Completed
Recruiting
Not yet recruiting
Any
RESULTS
Xuanwu Hospital Capital Medical University

45 Changchun St, Xicheng Qu, Beijing Shi, China

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Nanfang Hospital Southern Medical University

1838 Guangzhou N Ave, Baiyun Qu, Guangzhou Shi, Guangdong Sheng, China

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Henan Cancer Hospital

127 Dongming Rd, Zi Jing Shan Shang Quan, Jinshui Qu, Zhengzhou Shi, Henan Sheng, China

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Affiliated Hospital of Nantong University

20 Xisi Rd, Chongchuan Qu, Nantong Shi, Jiangsu Sheng, China

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Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

Tianjin, China

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Tianjin Medical University General Hospital

154 Anshan Rd, Heping Qu, China

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Peking Union Medical College Hospital

Dongdan, Beijing, Dongcheng, China

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Chinese PLA General Hospital (301 Hospital)

Side Rd of W. 4th Ring Rd Middle, Haidian Qu, Beijing Shi, China

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Guangdong General Hospital

106 Zhongshan 2nd Rd, Yuexiu Qu, Guangzhou Shi, Guangdong Sheng, China

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Shengjing Hospital of China Medical University

36 Sanhao St, Heping Qu, Shenyang Shi, Liaoning Sheng, China

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First Affiliated Hospital of Soochow University

China, Jiangsu Sheng, Suzhou Shi, 沧浪区凤凰街

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Tianjin Medical University General Hospital

154 Anshan Rd, Heping Qu, China

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The Affiliated Hospital of Xuzhou Medical Univeristy

Yunlong District, Xuzhou, China

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Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University

600 Yishan Rd, Xuhui Qu, Shanghai Shi, China

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The First Affiliated Hospital, College of Medicine, Zhejiang University

79 Qingchun Rd, Shangcheng Qu, Hangzhou Shi, Zhejiang Sheng, China

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Ruijin Hospital Shanghai Jiaotong University School of Medicine

182 Chongqing S Rd, Lu Wan Qu, Shanghai Shi, China

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Southern Cancer Center

29653 Anchor Cross Blvd, Daphne, AL 36526, USA

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Southern Cancer Center

Terrace Level, 6701 Airport Blvd Building B, Mobile, AL 36608, USA

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Southern Cancer Center

Terrace Level, 6701 Airport Blvd Building B, Mobile, AL 36608, USA

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Arizona Oncology Associates (Orange HOPE) - USOR

1845 W Orange Grove Rd Bldg 2, Tucson, AZ 85704, USA

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Arizona Oncology Associates (Rudasill HOPE) - USOR

2070 W Rudasill Rd #130, Tucson, AZ 85704, USA

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Arizona Oncology Associates (Wilmot HOPE) - USOR

603 N Wilmot Rd Suite 151, Tucson, AZ 85711, USA

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UC San Diego Moores Cancer Center

3855 Health Sciences Dr, La Jolla, CA 92037, USA

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Emad Ibrahim, MD, Inc

Center for Surgical and Specialty Care, 255 Terracina Blvd #104b, Redlands, CA 92373, USA

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Rocky Mountain Cancer Centers (Aurora) - USOR

1700 S Potomac St, Aurora, CO 80012, USA

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Rocky Mountain Cancer Centers (Boulder) - USOR

4715 Arapahoe Ave, Boulder, CO 80303, USA

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Rocky Mountain Cancer Centers (Colorado Springs) - USOR

2312 N Nevada Ave Suite 400, Colorado Springs, CO 80907, USA

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Quest Diagnostics, INC

695 S Broadway, Denver, CO 80209, USA

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Colorado Blood Cancer Institute - PPDS

1721 E 19th Ave ste 200-300, Denver, CO 80218, USA

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Presbyterian Saint Lukes Medical Center Laboratory

1719 E 19th Ave, Denver, CO 80218, USA

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Presbyterian/St. Luke's Medical Center

1719 E 19th Ave, Denver, CO 80218, USA

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Rocky Mountain Cancer Centers (Williams) - USOR

1800 N Williams St Suite 200, Denver, CO 80218, USA

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Rocky Mountain Cancer Centers (Denver) - USOR

4700 E Hale Pkwy Suite 400, Denver, CO 80220, USA

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Kaiser Foundation Health Plan

e, 11000 E 45th Ave, Denver, CO 80239, USA

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Laboratory Corporation of America

8490 Upland Dr, Englewood, CO 80112, USA

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Rocky Mountain Cancer Centers (Lakewood) - USOR

11750 W 2nd Pl Medical Plaza 1, Lakewood, CO 80228, USA

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Rocky Mountain Cancer Centers (Littleton) - USOR

22 W Dry Creek Cir, Littleton, CO 80120, USA

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Rocky Mountain Cancer Centers (Lone Tree) - USOR

10107 RidgeGate Parkway Suite 200, Lone Tree, CO 80124, USA

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Rocky Mountain Cancer Centers (Longmont) - USOR

2030 Mountain View Ave Suite 210, Longmont, CO 80501, USA

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Rocky Mountain Cancer Centers (Parker) - USOR

9397 Crown Crest Blvd, Parker, CO 80138, USA

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Rocky Mountain Cancer Centers (Pueblo) - USOR

3676 Parker Blvd #350, Pueblo, CO 81008, USA

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Rocky Mountain Cancer Centers (Thornton) - USOR

8820 Huron St, Thornton, CO 80260, USA

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Florida Cancer Specialists - NORTH - SCRI - PPDS

601 E Altamonte Dr, Altamonte Springs, FL 32701, USA

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SCRI Florida Cancer Specialists South

9776 Bonita Beach Rd SE Suite 201A, Bonita Springs, FL 34135, USA

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SCRI Florida Cancer Specialists South

2401 60th St Ct W, Bradenton, FL 34209, USA

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Florida Cancer Specialists - NORTH - SCRI - PPDS

403 S Kings Ave STE 100, Brandon, FL 33511, USA

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SCRI Florida Cancer Specialists South

1708 Cape Coral Pkwy W Suite 100, Cape Coral, FL 33914, USA

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Florida Cancer Specialists - NORTH - SCRI - PPDS

3280 McMullen Booth Rd STE 200, Clearwater, FL 33761, USA

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SCRI Florida Cancer Specialists South

3840 Broadway, Fort Myers, FL 33916, USA

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SCRI Florida Cancer Specialists South

3840 Broadway, Fort Myers, FL 33916, USA

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SCRI Florida Cancer Specialists South

3840 Broadway, Fort Myers, FL 33916, USA

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Florida Cancer Specialists - NORTH - SCRI - PPDS

6420 W. Newberry Road East Wing, Suite 100, Gainesville, FL 32605, USA

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Mayo Clinic Jacksonville - PPDS

4500 San Pablo Rd S, Jacksonville, FL 32224, USA

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Florida Cancer Specialists - NORTH - SCRI - PPDS

100 Highland Ave, Largo, FL 33770, USA

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Florida Cancer Specialists - NORTH - SCRI - PPDS

521 N Lecanto Hwy, Lecanto, FL 34461, USA

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University of Miami Miller School of Medicine

1150 NW 14th St, Miami, FL 33136, USA

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Baptist Health System (N Kendall) - USOR

8940 N Kendall Dr Suite 901E, Miami, FL 33176, USA

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SCRI Florida Cancer Specialists South

681 4th Ave S West, Naples, FL 34102, USA

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Florida Cancer Specialists - NORTH - SCRI - PPDS

8763 River Crossing Blvd, New Port Richey, FL 34655, USA

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Florida Cancer Specialists - NORTH - SCRI - PPDS

1630 SE 18th St STE 602, Ocala, FL 34471, USA

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Florida Cancer Specialists - NORTH - SCRI - PPDS

765 Image Way, Orange City, FL 32763, USA

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Florida Cancer Specialists - NORTH - SCRI - PPDS

70 W Gore St Suite 100, Orlando, FL 32806, USA

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SCRI Florida Cancer Specialists South

22395 Edgewater Dr, Port Charlotte, FL 33980, USA

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Florida Cancer Specialists - NORTH - SCRI - PPDS

1201 5th Ave N Suite 505, St. Petersburg, FL 33705, USA

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SCRI Florida Cancer Specialists South

1970 Golf St, Sarasota, FL 34236, USA

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SCRI Florida Cancer Specialists South

1970 Golf St, Sarasota, FL 34236, USA

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Florida Cancer Specialists - NORTH - SCRI - PPDS

7154 Medical Center Dr, Spring Hill, FL 34608, USA

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Florida Cancer Specialists - NORTH - SCRI - PPDS

3402 W Dr Martin Luther King Jr Blvd, Tampa, FL 33607, USA

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Florida Cancer Specialists - NORTH - SCRI - PPDS

4100 Waterman Way, Tavares, FL 32778, USA

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Florida Cancer Specialists - NORTH - SCRI - PPDS

1400 N, US-441 Suite 540, The Villages, FL 32159, USA

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SCRI Florida Cancer Specialists South

901 S Tamiami Trail, Venice, FL 34285, USA

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SCRI Florida Cancer Specialists South

901 S Tamiami Trail, Venice, FL 34285, USA

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Cleveland Clinic Florida

2950 Cleveland Clinic Blvd, Weston, FL 33331, USA

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Florida Cancer Specialists - NORTH - SCRI - PPDS

2100 Glenwood Dr Suite 102, Winter Park, FL 32792, USA

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Winship Cancer Institute, Emory University

1365 Clifton Rd, Atlanta, GA 30322, USA

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Saint Alphonsus Regional Medical Center

1055 N Curtis Rd, Boise, ID 83706, USA

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Saint Alphonsus Caldwell Cancer Care Center

3123 Medical Dr, Caldwell, ID 83605, USA

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Saint Alphonsus Medical Center

4300 E Flamingo Ave, Nampa, ID 83687, USA

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Menorah Medical Center

5721 W 119th St, Overland Park, KS 66209, USA

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Centerpoint Medical Center

19600 East 39th St S, Independence, MO 64057, USA

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HCA Midwest Health - SCRI - PPDS

5440 W 110th St Suite 400, Overland Park, KS 66211, USA

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Research Medical Center

2316 E Meyer Blvd, Kansas City, MO 64132, USA

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Nebraska Cancer Specialists

Midwest Cancer Center - Legacy, 17201 Wright St Suite 200, Omaha, NE 68130, USA

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Strong Memorial Hospital

601 Elmwood Ave, Rochester, NY 14642, USA

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University of North Carolina at Chapel Hill

Chapel Hill, NC, USA

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Oncology Hematology Care, Inc.

5053 Wooster Rd, Cincinnati, OH 45226, USA

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Oncology Hematology Care, Inc.

5053 Wooster Rd, Cincinnati, OH 45226, USA

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Oncology Hematology Care Inc - USOR

4350 Malsbary Rd 1st Floor, Cincinnati, OH 45242, USA

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Oncology Hematology Care Inc - USOR

4350 Malsbary Rd 1st Floor, Cincinnati, OH 45242, USA

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Fairview Hospital

18101 Lorain Ave, Cleveland, OH 44111, USA

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The Cleveland Clinic Foundation

9500 Euclid Ave, Cleveland, OH 44195, USA

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Oncology Hematology Care, Inc - Fairfield

3050 Mack Rd Suite 300, Fairfield, OH 45014, USA

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Hillcrest Hospital Cancer Care Center

6780 Mayfield Rd, Cleveland, OH 44124, USA

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St. Luke's Hospital

801 Ostrum St, Bethlehem, PA 18015, USA

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St. Luke's University Health Network

1872 St Luke's Blvd, Easton, PA 18045, USA

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Greenville Health System

109 Fleetwood Dr, Easley, SC 29640, USA

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Greenville Health System

701 Grove Rd, Greenville, SC 29605, USA

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Greenville Health System Cancer Institute

65 International Dr, Greenville, SC 29615, USA

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Greenville Health System

3308 Brushy Creek Rd, Greer, SC 29650, USA

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Greenville Health System

298 Memorial Dr, Seneca, SC 29672, USA

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Greenville Health System

333 S Pine St, Spartanburg, SC 29302, USA

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Tennessee Oncology - DICKSON - SCRI - PPDS

103 Natchez Park Dr Suite 103, Dickson, TN 37055, USA

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Tennessee Oncology - FRANKLIN - SCRI - PPDS

4488 Carothers Pkwy Suite 300, Franklin, TN 37067, USA

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Tennessee Oncology - GALLATIN - SCRI - PPDS

225 Big Station Camp Blvd #201, Gallatin, TN 37066, USA

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Tennessee Oncology - SUMMIT - SCRI - PPDS

5653 Frist Blvd #434, Hermitage, TN 37076, USA

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Tennessee Oncology - LEBANON - SCRI - PPDS

103 Physician's Way suite 103, Lebanon, TN 37090, USA

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Tennessee Oncology - MURFREESBORO - SCRI - PPDS

1840 Medical Center Pkwy #100, Murfreesboro, TN 37129, USA

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Sarah Cannon Center for Blood Centers - SCRI - PPDS

2300 Patterson St, Nashville, TN 37203, USA

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Tennessee Oncolgy - BAPTIST - SCRI - PPDS

2004 Hayes St #350, Nashville, TN 37203, USA

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Tennessee Oncology NASH - SCRI - PPDS

250 25th Ave N #412, Nashville, TN 37203, USA

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Tennessee Oncology - ST THOMAS WEST - SCRI - PPDS

4220 Harding Pike #200, Nashville, TN 37205, USA

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Tennessee Oncology SKYLINE - SCRI - PPDS

3443 Dickerson Pike #760, Nashville, TN 37207, USA

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Tennessee Oncology - SOUTHERN HILLS - SCRI - PPDS

397 Wallace Rd #201, Nashville, TN 37211, USA

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Tennessee Oncology - SHELBYVILLE - SCRI - PPDS

Shelbyville, TN, USA

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Tennessee Oncology - SMYRNA - SCRI - PPDS

300 StoneCrest Boulevard # 400, Smyrna, TN 37167, USA

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Baylor Sammons Cancer Center

3410 Worth St STE 400, Dallas, TX 75246, USA

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University of Texas Southwestern Medical Center

5323 Harry Hines Blvd, Dallas, TX 75390, USA

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Texas Oncology (Tyler) - USOR

1300 Fourth St, Longview, TX 75601, USA

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Texas Oncology (E Common) - USOR

1448 E Common St, New Braunfels, TX 78130, USA

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Texas Oncology - San Antonio Medical Center - USOR

5206 Research Dr, San Antonio, TX 78240, USA

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Texas Oncology (Tyler) - USOR

910 E Houston St Suite 100, Tyler, TX 75702, USA

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Oncology and Hematology Associates of Southwest Virginia (Blacksburg) - USOR

2600 Research Center Dr Suite A, Blacksburg, VA 24060, USA

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University of Virginia

Charlottesville, VA, USA

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Oncology and Hematology Associates of Southwest Virginia (Low Moor) - USOR

1 Arh Ln Suite 203, Low Moor, VA 24457, USA

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Oncology and Hematology Associates of Southwest Virginia (Roanoke) - USOR

2013 S Jefferson St, Roanoke, VA 24014, USA

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Oncology and Hematology Associates of Southwest Virginia Inc

1802 Braeburn Dr, Salem, VA 24153, USA

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Oncology and Hematology Associates of Southwest Virginia

1155 N 4th St, Wytheville, VA 24382, USA

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Royal Hobart Hospital

48 Liverpool St, Hobart TAS 7000, Australia

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Liverpool Hospital

Elizabeth &, Goulburn St, Liverpool NSW 2170, Australia

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AZ Sint-Jan AV

Ruddershove 10, 8000 Brugge, Belgium

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Cliniques Universitaires Saint-Luc

Avenue Hippocrate 10, 1200 Bruxelles, Belgium

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Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner

R. Dr. Ovande do Amaral, 201 - Jardim das Américas, Curitiba - PR, 81520-060, Brazil

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Liga Norte Riograndense Contra O Cancer

Av. Miguel Castro, 1355 - Dix-Sept Rosado, Natal - RN, 59075-740, Brazil

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Centro de Pesquisas Oncologicas

Rod. Admar Gonzaga, 655 - Itacorubi, Florianópolis - SC, 88034-000, Brazil

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Hospital de Clinicas de Porto Alegre (HCPA) - PPDS

Rua Ramiro Barcelos, 2350 - Av. Protásio Alves, 211 - Santa Cecilia, Porto Alegre - RS, 90035-903, Brazil

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Hospital Santa Marcelina

R. Santa Marcelina, 177 - Vila Carmosina, São Paulo - SP, 08270-070, Brazil

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Hospital Santa Marcelina

R. Santa Marcelina, 177 - Vila Carmosina, São Paulo - SP, 08270-070, Brazil

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Tom Baker Cancer Centre

1331 29 St NW, Calgary, AB T2N 4N2, Canada

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Sunnybrook Health Sciences Centre

43 Wellesley St E, Toronto, ON M4Y 1H1, Canada

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Princess Margaret Hospital

610 University Ave, Toronto, ON M5G 2M9, Canada

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Princess Margaret Hospital

610 University Ave, Toronto, ON M5G 2M9, Canada

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Fakultni nemocnice Hradec Kralove

Sokolská 581, Nový Hradec Králové, 500 05 Hradec Králové, Czechia

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Vseobecna Fakultni Nemocnice V Praze

U Nemocnice 499/2, 128 08 Praha 2-Nové Město, Czechia

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Fakultni nemocnice Kralovske Vinohrady

Šrobárova 1150/50, Vinohrady, 100 34 Praha 10, Czechia

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CHU Angers

4 Rue Larrey, 49100 Angers, France

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Centre Hospitalier Le Mans

194 Avenue Rubillard, 72037 Le Mans, France

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Hopital Saint Louis

1 Avenue Claude Vellefaux, 75010 Paris, France

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Hopital Saint Louis

1 Avenue Claude Vellefaux, 75010 Paris, France

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Universitatsklinikum Leipzig

Liebigstraße 20, 04103 Leipzig, Germany

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Universitatsklinikum Carl Gustav Carus an der TU Dresden

Fetscherstraße 74, 01307 Dresden, Germany

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Marien Hospital Akademisches Lehrkrankenhaus

Rochusstraße 2, 40479 Düsseldorf, Germany

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Laiko General Hospital of Athens

Athens, Greece

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Athens General Hospital 'G Gennimatas'

Leof. Mesogeion 154, Athina 115 27, Greece

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Attikon University General Hospital

Rimini 1, Chaidari 124 62, Greece

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University Hospital of Alexandroupolis

Alexandroupoli 681 00, Greece

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Laiko General Hospital of Athens

Athens, Greece

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University General Hospital of Larissa

Tsakalof 1, Larisa 412 21, Greece

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University General Hospital of Patras

Rio 265 04, Greece

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Georgios Papanikolaou General Hospital of Thessaloniki

Leof. Papanikolaou, Pilea Chortiatis 570 10, Greece

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Edith Wolfson Medical Center

Ha-Lokhamim St 62, Holon, 5822012, Israel

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Shaare Zedek Medical Center

Shmu'el Bait St 12, Jerusalem, 9103102, Israel

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Hadassah Medical Center PPDS -

Jerusalem, Israel

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ZIV Medical Center

Derech HaRambam, Tsfat, Israel

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Tel Aviv Sourasky Medical Center PPDS

Weizmann St 6, Tel Aviv-Yafo, Israel

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Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi

Via Giuseppe Massarenti, 13, 40138 Bologna BO, Italy

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ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia - INCIPIT - PIN

Viale Europa, 15, 25123 Brescia BS, Italy

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Azienda Ospedaliera Universitaria Careggi

Largo Piero Palagi, 1, 50139 Firenze FI, Italy

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Azienda Ospedaliero Universitaria San Giovanni Battista Di Torino

Corso Bramante, 88, 10126 Torino TO, Italy

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Azienda Ospedaliero Universitaria San Giovanni Battista Di Torino

Corso Bramante, 88, 10126 Torino TO, Italy

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Japan Mutual Aid Association of Public School Teachers Chugoku Central Hospital

Japan, 〒720-0001 Hiroshima, Fukuyama, Miyukichō, Kamiiwanari, 大字上岩成148−13

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Hokkaido University Hospital

5 Chome Kita 14 Jonishi, Kita Ward, Sapporo, Hokkaido 060-8648, Japan

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Fukushima Medical University Hospital

1-番地 Hikarigaoka, Fukushima, 960-1247, Japan

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Kobe City Medical Center General Hospital

Japan, 〒650-0047 Hyogo, Kobe, Chūō-ku, Minatojima Minamimachi, 2-chōme−1−1

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Kindai University Hospital

377-2 Ōnohigashi, Osakasayama, Osaka 589-8511, Japan

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Saitama Medical Center

1981番地 Kamoda, Kawagoe, Saitama 350-8550, Japan

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Juntendo University Hospital

3-chōme-1-番3号 Hongō, Bunkyo City, Tōkyō-to 113-8431, Japan

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NTT Medical Center Tokyo

5-chōme-9-22 Higashigotanda, Shinagawa City, Tōkyō-to 141-0022, Japan

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Kyushu University Hospital

3-chōme-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan

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Dokkyo Medical University Hospital

880 Kitakobayashi, Mibu, Shimotsuga-gun, Tochigi 321-0207, Japan

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Nagasaki University Hospital

1-chōme-7-1 Sakamoto, Nagasaki, 852-8501, Japan

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Osaka City University Hospital

1-chōme-5-7 Asahimachi, Abeno-ku, Osaka, 545-8586, Japan

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Yokohama City University Hospital

3 Chome-9 Fukuura, Kanazawa Ward, Yokohama, Kanagawa 236-0004, Japan

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University of Fukui Hospital

23-3 Matsuokashimoaizuki, Eiheiji, Yoshida-gun, Fukui 910-1193, Japan

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Kyungpook National University Hospital

130 Dongdeok-ro, Samdeokdong 2(i)-ga, Jung-gu, Daegu, South Korea

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Asan Medical Center - PPDS

88 Olympic-ro 43-gil, Pungnap 2(i)-dong, Songpa-gu, Seoul, South Korea

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Hematologica Alta Especialidad S.C.

South Carolina, USA

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Capital Humano para Investigacion Clinica SC

South Carolina, USA

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Instytut Hematologii i Transfuzjologii

Indiry Gandhi 14, 02-776 Warszawa, Poland

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Uniwersyteckie Centrum Kliniczne, Klinika Hematologii I Transplantologii, Budynek Centrum Medycyny N

Dębinki 26, 80-211 Gdańsk, Poland

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Uniwersyteckie Centrum Kliniczne

Dębinki 7, 80-952 Gdańsk, Poland

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Swietokrzyskie Centrum Onkologii

Prezydenta Stefana Artwińskiego 3, 25-734 Kielce, Poland

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Centrum Onkologii Ziemi Lubelskiej

Doktora Kazimierza Jaczewskiego 7, 20-090 Lublin, Poland

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Zaklad Diagnostyki Obrazowej SOR

aleja Wincentego Witosa 26, 46-020 Opole, Poland

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Szpital Wojewodzki w Opolu

Augustyna Kośnego 53, 46-020 Opole, Poland

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City Clinical Hospital # 40

Moscow, Russia, 129301

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North-West Federal Medical Research Center n.a. V.A. Almazov

Ulitsa Akkuratova, 2, Sankt-Peterburg, Russia, 197341

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Russian Research Institute of Hematology and Blood Transfusion

St Petersburg, Russia, 191024

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ICO lHospitalet Hospital Duran i Reynals

Avinguda de la Granvia de l’Hospitalet, 199, 08908 L'Hospitalet de Llobregat, Barcelona, Spain

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Complejo Asistencial Universitario de Leon

Calle Altos de nava, s/n, 24001 León, Spain

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Hospital Universitario Vall d'Hebron - PPDS

Passeig de la Vall d'Hebron, 119, 08035 Barcelona, Spain

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Hospital General Universitario Gregorio Maranon

Calle del Dr. Esquerdo, 46, 28007 Madrid, Spain

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Hospital Universitario Ramon y Cajal

M-607, km. 9, 100, 28034 Madrid, Spain

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Hospital Universitario La Paz - PPDS

Paseo de la Castellana, 261, 28046 Madrid, Spain

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Complejo Asistencial Universitario de Salamanca H. Clinico

Paseo de San Vicente, 58, 37007 Salamanca, Spain

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Hospital Clinico Universitario de Valencia

Av. de Blasco Ibáñez, 17, 46010 València, Valencia, Spain

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Hospital Universitari i Politecnic La Fe de Valencia

Avinguda de Fernando Abril Martorell, 106, 46026 València, Valencia, Spain

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Ege University Medical Faculty

Kazımdirik, Ege Ünv. Hst. No:9, 35100 Bornova/İzmir, Turkey

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Mersin University Medical Faculty

Çiftlikköy, Mersin Ünv., 33110 Yenişehir/Mersin, Turkey

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Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi

Kale, İstiklal Cd. No:27, 55030 İlkadım/Samsun, Turkey

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Namik Kemal University

Namık Kemal, Kampüs Cad No:1, 59030 Süleymanpaşa/Tekirdağ, Turkey

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Karadeniz Technical University Faculty of Medicine

Üniversite, Merkez, Farabi Cd. No:66, 61080 Ortahisar/Trabzon, Turkey

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Maidstone Hospital

Hermitage Ln, Maidstone ME16 9QQ, UK

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Singleton Hospital - PPDS

Sketty Ln, Sketty, Swansea SA2 8QA, UK

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Southeastern Regional Medical Center - CTCA - PPDS

14200 West, Celebrate Life Way, Goodyear, AZ 85338, USA

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Compassionate Care Research Group Inc. at Compassionate Cancer Care Medical Group, Inc

260 E Ontario Ave #101, Corona, CA 92879, USA

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Compassionate Cancer Care Medical Group Inc

11180 Warner Ave #351, Fountain Valley, CA 92708, USA

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Compassionate Care Research Group Inc. at Compassionate Cancer Care Medical Group, Inc

4500 Brockton Ave #107, Riverside, CA 92501, USA

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Medstar Research Institute

100 Irving St NW #5123, Washington, DC 20010, USA

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Rush University Medical Center

1620 W Harrison St, Chicago, IL 60612, USA

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New Jersey Hematology Oncology Associates LLC

1608 New Jersey Route 88, West, suite 250, Brick Township, NJ 08724, USA

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John Theurer Cancer Center

92 2nd St, Hackensack, NJ 07601, USA

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New Jersey Hematology and Oncology

508 Lakehurst Rd #1b, Toms River, NJ 08755, USA

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Weill Cornell Medical Center - Monitoring Location

1305 York Ave, New York, NY 10021, USA

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Weill Cornell Medical Center

525 E 68th St, New York, NY 10065, USA

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Texas Oncology (West 38) - USOR

901 W 38th St Suite 200, Austin, TX 78705, USA

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Texas Oncology (Balcones) - USOR

6204 Balcones Dr, Austin, TX 78731, USA

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Texas Oncology (James Casey) - USOR

4101 James Casey St Suite 100, Austin, TX 78745, USA

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Texas Oncology (Medical City) - USOR

7777 Forest Ln Suite D400, Dallas, TX 75230, USA

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Texas Oncology (Round Rock) - USOR

2410 Round Rock Ave Suite 150, Round Rock, TX 78681, USA

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Icon Cancer Care Wesley

1/40 Chasely St, Auchenflower QLD 4066, Australia

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Icon Cancer Care Chermside

259 Wickham Terrace, Spring Hill QLD 4000, Australia

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Icon Cancer Care South Brisbane

293 Vulture St, South Brisbane QLD 4101, Australia

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Icon Cancer Care

293 Vulture St, South Brisbane QLD 4101, Australia

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Icon Cancer Care Southport

9/39 White St, Southport QLD 4215, Australia

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Algemeen Ziekenhuis Klina

Augustijnslei 100, 2930 Brasschaat, Belgium

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CHU UCL Namur asbl - Site Godinne

Rue Dr Gaston Therasse 1, 5530 Yvoir, Belgium

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UZ Leuven

Herestraat 49, 3000 Leuven, Belgium

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Universidade Federal do Rio de Janeiro - UFRJ

Av. Pedro Calmon, 550 - Cidade Universitária da Universidade Federal do Rio de Janeiro, Rio de Janeiro - RJ, 21941-901, Brazil

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University of Alberta

Edmonton, AB T6G 2B7, Canada

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Kaye Edmonton Clinic

11400 University Ave, Edmonton, AB T6G 1Z1, Canada

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Saint John Regional Hospital

400 University Ave, Saint John, NB E2L 4L2, Canada

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Hopital Cote de Nacre

Avenue de la Côte de Nacre, 14000 Caen, France

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Universitatsklinikum Tubingen

Hoppe-Seyler-Straße 3, 72076 Tübingen, Germany

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University General Hospital of Ioannina

Οδός Σταύρου Νιάρχου, Neochoropoulo 455 00, Greece

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Galilee Medical Center

89 Nahariya-Cabri, Nahariya, Israel

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IRCCS Centro Di Riferimento Oncologico Della Basilicata

Via Padre Pio, 1, 85028 Rionero In Vulture PZ, Italy

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Istituto Clinico Humanitas

Via Alessandro Manzoni, 56, 20089 Rozzano MI, Italy

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University Hospital, Kyoto Prefectural University of Medicine

Japan, 〒602-0841 Kyoto, Kamigyō-ku, 広小路上 梶井465

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Chonnam National University Hwasun Hospital

Hwasun-gun, Jeollanam-do, South Korea

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Pusan National University Hospital

179 Gudeok-ro, Amidong 1(il)-ga, Seo-gu, Busan, South Korea

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Samsung Medical Center - PPDS

81 Irwon-ro, Irwonbon-dong, Gangnam-gu, Seoul, South Korea

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The Catholic University of Korea, Seoul St. Mary's Hospital

222 Banpo-daero, Banpo-dong, Seocho-gu, Seoul, South Korea

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Hospital Universitario de La Princesa

Calle de Diego de León, 62, 28006 Madrid, Spain

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Gazi University Medical Faculty Gazi Hospital

Emniyet, Mevlana Blv. No:29, 06560 Yenimahalle/Ankara, Turkey

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Royal Bournemouth Hospital

Castle Ln E, Bournemouth BH7 7DW, UK

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St Bartholomew's Hospital

W Smithfield, London EC1A 7BE, UK

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View all (256)
Trial Protocol ID: Pevonedistat-3001
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