Non Hodgkin Lymphoma Clinical Trial

A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL

Summary

This study is evaluating the efficacy of acalabrutinib in combination with bendamustine and rituximab (BR) compared with placebo plus BR in subjects with previously untreated mantle cell lymphoma.

View Full Description

Full Description

To evaluate the efficacy of acalabrutinib in combination with bendamustine and rituximab (BR) compared with placebo plus BR based on Independent Review Committee (IRC) assessment of progression-free survival (PFS) per the Lugano Classification for Non-Hodgkin Lymphoma (NHL) in subjects with previously untreated mantle cell lymphoma (MCL).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Men and women, ≥ 65 years of age.
Pathologically confirmed MCL, with documentation of a chromosome translocation t(11;14)(q13;q32) and/or overexpression of cyclin D1 in association with other relevant markers (eg, CD5, CD19, CD20, PAX5) .
MCL requiring treatment and for which no prior systemic anticancer therapies have been received.
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
Agreement to use highly effective forms of contraception during the study and 6 months after the last dose of bendamustine, or 12 months after the last dose of rituximab, whichever is longest .

Exclusion Criteria:

Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of first dose of study drug, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or corrected QT interval (QTc) > 480 msec (calculated using Friderica's formula: QT/RR0.33) at screening. Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study.
Malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach, extensive small bowel resection that is likely to affect absorption, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass.
Uncontrolled active systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment), or intravenous anti infective treatment within 2 weeks before first dose of study drug.
Concurrent participation in another therapeutic clinical trial.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

626

Study ID:

NCT02972840

Recruitment Status:

Recruiting

Sponsor:

Acerta Pharma BV

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There are 215 Locations for this study

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Downey California, 90241, United States
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Santa Monica California, 90404, United States
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New Haven Connecticut, 06510, United States
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Washington District of Columbia, 20007, United States
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Tallahassee Florida, 32308, United States
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West Palm Beach Florida, 33401, United States
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Marietta Georgia, 30060, United States
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Westwood Kansas, 66205, United States
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Louisville Kentucky, 40207, United States
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Ann Arbor Michigan, 48109, United States
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Rochester Minnesota, 55905, United States
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Kansas City Missouri, 64132, United States
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Saint Louis Missouri, 63110, United States
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Hackensack New Jersey, 07601, United States
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Morristown New Jersey, 07960, United States
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Hawthorne New York, 10532, United States
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Lake Success New York, 11042, United States
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Portland Oregon, 97239, United States
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Charleston South Carolina, 29425, United States
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Greenville South Carolina, 29615, United States
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Chattanooga Tennessee, 37404, United States
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Nashville Tennessee, 37203, United States
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Houston Texas, 77030, United States
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San Antonio Texas, 78217, United States
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San Antonio Texas, 78217, United States
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Tyler Texas, 75702, United States
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Charlottesville Virginia, 22908, United States
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Fort Belvoir Virginia, 22060, United States
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Seattle Washington, 98108, United States
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Seattle Washington, 98109, United States
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Seattle Washington, 98122, United States
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Morgantown West Virginia, 26506, United States
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Buenos Aires , C1114, Argentina
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Buenos Aires , C1426, Argentina
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Buenos Aires , C1430, Argentina
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Buenos Aires , C1431, Argentina
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Caba , C1118, Argentina
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Cordoba , 5000, Argentina
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Bedford Park , 5042, Australia
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Concord , 2139, Australia
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Frankston , 3199, Australia
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Gosford , 2250, Australia
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Heidelberg , 3084, Australia
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Herston , QLD, , Australia
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Kogarah , NSW 2, Australia
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Murdoch , 6150, Australia
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Nedlands , 6009, Australia
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Newcastle , 2298, Australia
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Southport , 4215, Australia
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Sydney , NSW 2, Australia
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Woolloongabba , 4102, Australia
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Antwerpen , 2060, Belgium
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Ghent , 9000, Belgium
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Leuven , 3000, Belgium
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Roeselare , 8900, Belgium
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Sint-Niklaas , 9100, Belgium
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Bela Vista , 01321, Brazil
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Curitiba , 81520, Brazil
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Porto Alegre , 90035, Brazil
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Porto Alegre , RS 90, Brazil
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Salvador , 41253, Brazil
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Sao Paulo , 01232, Brazil
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Sao Paulo , 05652, Brazil
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Sao Paulo , 12360, Brazil
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Sao Paulo , 5403, Brazil
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So Paulo , 08270, Brazil
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Vancouver British Columbia, V5Z 4, Canada
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Oshawa Ontario, L1G 2, Canada
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Toronto Ontario, M4N 3, Canada
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Edmonton , T6G 1, Canada
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Greenfield Park , J4V 2, Canada
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Halifax , NS B3, Canada
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Beijing , 10003, China
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Beijing , 10003, China
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Changchun , 13002, China
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Changsha , 41000, China
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Chongqing , 40003, China
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Dalian , 11602, China
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Fuzhou City , 35000, China
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Gongshu District , 31002, China
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Guangzhou , 51008, China
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Guangzhou , , China
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Haidian District , 10019, China
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Haikou , 57031, China
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Hangzhou , 31000, China
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Harbin , 15008, China
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Lanzhou , 73003, China
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Nanchang , 33000, China
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Nanchang , 33002, China
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Nanjing , 21002, China
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Qingdao , 26610, China
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Shanghai , , China
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Shenyang , , China
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Suzhou , 21500, China
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Tianjian , 30002, China
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Tianjin , , China
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Wenzhou , 32500, China
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Wuhan , 43003, China
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Wuhan , 43007, China
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Wuhou District , 61004, China
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Xicheng District , 10005, China
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Xuhui District , 20003, China
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Xuzhou , 22100, China
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Zhengzhou City , 45000, China
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Zhengzhou , 45000, China
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Brno , 625 0, Czechia
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Hradec Kralove , 500 0, Czechia
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Ostrava Poruba , 708 5, Czechia
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Pilsen , 30460, Czechia
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Prague , 100 3, Czechia
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Argenteuil , 95100, France
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Bobigny , 93000, France
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Bordeaux , 33076, France
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Le Mans , 72000, France
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Limoges , 87042, France
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Perigueux , 24019, France
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Pessac , 33604, France
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Rennes Cedex , 35000, France
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Vienne , 86000, France
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Heidelberg , 69120, Germany
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Muenster , 48149, Germany
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Munchen , 81377, Germany
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Nordrhein-Westfalen , 52064, Germany
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Ravensburg , 88212, Germany
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Rheinland-Pfalz , 55131, Germany
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Ulm , 89081, Germany
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Athens , 11525, Greece
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Athens , 11527, Greece
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Athens , 11528, Greece
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Ioannina , 45500, Greece
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Patras , 26504, Greece
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Thessaloniki , 54007, Greece
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Thessaloniki , 57010, Greece
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HKG , 99907, Hong Kong
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Pok Fu Lam , , Hong Kong
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Budapest , 1085, Hungary
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Budapest , 1122, Hungary
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Debrecen , 4032, Hungary
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Győr , 9024, Hungary
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Pecs , 7624, Hungary
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Szeged , 6725, Hungary
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Haifa , 31096, Israel
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Jerusalem , 91031, Israel
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Petah Tikva , 49414, Israel
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Tel Aviv , 64239, Israel
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Bologna , 40138, Italy
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Milano , 20132, Italy
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Milano , 20162, Italy
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Palermo , 90146, Italy
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Parma , , Italy
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Pavia , 27100, Italy
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Reggio Emilia , 42123, Italy
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Rozzano , 20089, Italy
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Turin , 10126, Italy
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Fukuoka City , 812-8, Japan
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Fukuoka , 811-1, Japan
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Kobe-shi , 650-0, Japan
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Kumamoto , 860-8, Japan
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Kyoto-city , 602-8, Japan
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Matsuyama-shi , 791-0, Japan
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Nagoya-shi , 464-8, Japan
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Nagoya , 460-0, Japan
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Okayama , 700-8, Japan
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Osaka , 565-0, Japan
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Sapporo-shi , 003-0, Japan
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Sendai-shi , 980-8, Japan
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Shimane , 693-8, Japan
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Tokyo , 104-0, Japan
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Tokyo , 135-8, Japan
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Tokyo , 152-8, Japan
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Yokohama-shi , 241-8, Japan
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Busan , 49201, Korea, Republic of
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Gyeonggi-do , 13620, Korea, Republic of
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Seoul , 3080, Korea, Republic of
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Seoul , 3722, Korea, Republic of
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Seoul , 5505, Korea, Republic of
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Seoul , 6351, Korea, Republic of
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Seoul , 6591, Korea, Republic of
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Mexico , 14080, Mexico
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Queretaro , 76090, Mexico
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Dunedin , 9016, New Zealand
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Grafton , 1023, New Zealand
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Otahuhu , 1640, New Zealand
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Bellavista , , Peru
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Lima , 1, Peru
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Lima , 34, Peru
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Chorzow , 41-50, Poland
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Krakow , 30-51, Poland
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Lodz , 93-51, Poland
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Lublin , 20-09, Poland
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Olsztyn , 10-22, Poland
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Warszawa , 02-10, Poland
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Warszawa , 02-77, Poland
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Warszawa , 04-14, Poland
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Woj. Podkarpackie , 36-20, Poland
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Wroclaw , 50-36, Poland
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Brasov , 50012, Romania
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Bucharest , 07013, Romania
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Cluj-Napoca , 40012, Romania
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Iasi , 70048, Romania
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Pyatigorsk , 35753, Russian Federation
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Saint Petersburg , 19702, Russian Federation
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St. Petersburg , 19734, Russian Federation
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St. Petersburg , , Russian Federation
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Syktyvkar , 16702, Russian Federation
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Tula , 30005, Russian Federation
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Badalona , 8916, Spain
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Barcelona , 8003, Spain
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Barcelona , 8035, Spain
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Barcelona , 8907, Spain
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Barcelona , , Spain
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Madrid , 28007, Spain
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Madrid , 28040, Spain
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Madrid , 28046, Spain
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Majadahonda , 28222, Spain
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Pamplona , 31008, Spain
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Sevilla , , Spain
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Valencia , 46026, Spain
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Kaohsiung , 833, Taiwan
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Taichung , 40447, Taiwan
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Taipei , 100, Taiwan
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Cherkasy , 18009, Ukraine
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Chernihiv , 14029, Ukraine
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Dnipropetrovsk , 49102, Ukraine
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Kiev , 3022, Ukraine
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Lviv , 79044, Ukraine
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Zhytomir , 10002, Ukraine
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Hanoi , 123, Vietnam
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Hanoi , , Vietnam
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Ho Chi Minh City , WARD , Vietnam
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Ho Chi Minh , 70000, Vietnam

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

626

Study ID:

NCT02972840

Recruitment Status:

Recruiting

Sponsor:


Acerta Pharma BV

How clear is this clinincal trial information?

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