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Trial record 3 of 37 for:    Acerta Pharma

A Study of Bendamustine and Rituximab Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated Mantle Cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02972840
Recruitment Status : Recruiting
First Posted : November 25, 2016
Last Update Posted : September 18, 2019
Sponsor:
Information provided by (Responsible Party):
Acerta Pharma BV

Brief 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.

Condition or disease Intervention/treatment Phase
Lymphoma, Mantle Cell Drug: Acalabrutinib in combination with bendamustine and rituximab Drug: Placebo in combination with bendamustine and rituximab Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 546 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Bendamustine and Rituximab (BR) Alone Versus in Combination With Acalabrutinib (ACP-196) in Subjects With Previously Untreated Mantle Cell Lymphoma
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : April 2023


Arm Intervention/treatment
Experimental: Acalabrutinib in combination with bendamustine and rituximab
Acalabrutinib administered twice per day (BID) orally (PO) plus bendamustine on Days 1 and 2 and rituximab on Day 1; cycles are repeated every 28 days.
Drug: Acalabrutinib in combination with bendamustine and rituximab
Acalabrutinib in combination with BR

Placebo Comparator: Placebo in combination with bendamustine and rituximab
Matching placebo administered BID PO plus bendamustine on Days 1 and 2 and rituximab on Day 1; cycles are repeated every 28 days.
Drug: Placebo in combination with bendamustine and rituximab
Placebo in combination with BR




Primary Outcome Measures :
  1. Progression-free survival per the Lugano Classification for NHL in Arm 1 compared to Arm 2 [ Time Frame: 48 months ]

Secondary Outcome Measures :
  1. Investigator-assessed progression-free survival per the Lugano Classification for NHL in Arm 1 compared to Arm 2 [ Time Frame: 48 months ]
  2. Investigator-assessed overall response rate per the Lugano Classification for NHL in Arm 1 compared to Arm 2 [ Time Frame: 48 months ]
  3. IRC-assessed overall response rate per the Lugano Classification for NHL in Arm 1 compared to Arm 2 [ Time Frame: 48 months ]
  4. Overall survival in Arm 1 compared to Arm 2 [ Time Frame: 48 months ]
  5. IRC-assessed duration of response per the Lugano Classification for NHL in Arm 1 compared to Arm 2 [ Time Frame: 48 months ]
  6. IRC assessed time to response per the Lugano Classification for NHL in Arm 1 compared to Arm 2 [ Time Frame: 48 months ]


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02972840


Contacts
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Contact: Call Center 1-888-292-9613 Acertamc@dlss.com

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Locations
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United States, California
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Santa Monica, California, United States, 90404
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Whittier, California, United States, 90603
United States, Connecticut
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New Haven, Connecticut, United States, 06510
United States, District of Columbia
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Washington, District of Columbia, United States, 20007-2113
United States, Florida
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Fort Myers, Florida, United States, 33916
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Plantation, Florida, United States, 33322
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Saint Petersburg, Florida, United States, 33705
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West Palm Beach, Florida, United States, 33407
United States, Georgia
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Marietta, Georgia, United States, 30060-1173
United States, Kansas
Overland Park, KS 66209 Recruiting
Overland Park, Kansas, United States, 66209
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Westwood, Kansas, United States, 66205
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Louisville, Kentucky, United States, 40207-4723
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Ann Arbor, Michigan, United States, 48109
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Rochester, Minnesota, United States, 55905
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Saint Louis, Missouri, United States, 63110
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Hackensack, New Jersey, United States, 07601
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Morristown, New Jersey, United States, 07962
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Hawthorne, New York, United States, 10532
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Lake Success, New York, United States, 11042
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New York, New York, United States, 10016
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Canton, Ohio, United States, 44718
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Portland, Oregon, United States, 97239-3011
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Charleston, South Carolina, United States, 29425
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Greenville, South Carolina, United States, 29615
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Chattanooga, Tennessee, United States, 37404
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Nashville, Tennessee, United States, 37203
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Dallas, Texas, United States, 75246
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McAllen, Texas, United States, 78504
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Charlottesville, Virginia, United States, 22908
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Morgantown, West Virginia, United States, 26506-9162
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Córdoba, Argentina, 5000
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Gosford, Australia, 2250
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Passo Fundo, Brazil, 99010-260
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Porto Alegre, Brazil, 90470-340
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Porto Alegre, Brazil, 90610-000
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Rio De Janeiro, Brazil, 20231-050
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Salvador, Brazil, 41253-190
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São Paulo, Brazil, 01236-030
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São Paulo, Brazil, 01321-001
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Guangzhou, Guangdong, China, 510515
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Beijing, Hai-Dian Qu, China, 100091
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Beijing, Haidan, China, 100191
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Zhengzhou, Henan, China, 45000
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Zhengzhou, Henan, China, 450046
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Tianjin, Heping, China, 300020
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Shanghai, Huangpu, China, 200025
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Wuhan, Hubei, China, 430000
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Wuhan, Hubei, China, 430030
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Nanjing, Jiangsu, China, 210029
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Suzhou, Jiangsu, China, 215006
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Xuzhou, Jiangsu, China, 221000
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Argenteuil, France, 95100
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Aachen, Germany, 52064
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Thessaloníki, Greece, 57010
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Hong Kong, Hong Kong
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Tuen Mun, Hong Kong, 999077
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Budapest, Hungary, 1083
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Budapest, Hungary, 1122
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Győr, Hungary, 9023
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Pécs, Hungary, 7624
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Szeged, Hungary, H-6725
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Haifa, Israel, 310961
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Jerusalem, Israel, 9103012
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Petaẖ Tiqwa, Israel, 49100
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Tel Aviv, Israel, 64239
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Bologna, Italy, 40138
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Milano, Italy, 20132
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Milano, Italy, 20162
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Parma, Italy, 43126
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Pavia, Italy, 27100
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Rozzano, Italy, 20089
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Torino, Italy, 10126
Japan
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Aichi, Japan, 464-8681
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Ehime, Japan, 791-0280
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Fukuoka, Japan, 811-1395
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Fukuoka, Japan, 812-8582
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Hokkaido, Japan, 003-0006
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Kumamoto, Japan, 860-8556
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Miyagi, Japan, 980-8574
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Okayama, Japan, 700-8558
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Osaka, Japan, 565-0871
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Shimane, Japan, 693-8501
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Tokyo, Japan, 104-0045
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Tokyo, Japan, 135-8550
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Tokyo, Japan, 152-8902
Korea, Republic of
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Busan, Korea, Republic of, 49201
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Seongnam-si, Korea, Republic of, 13620
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Seoul, Korea, Republic of, 3080
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Seoul, Korea, Republic of, 3722
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Seoul, Korea, Republic of, 5505
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Seoul, Korea, Republic of, 6351
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Seoul, Korea, Republic of, 6591
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Seoul, Korea, Republic of, 7985
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Ciudad de mexico, Mexico, 14080
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Querétaro, Mexico, 76090
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Warszawa, Poland, 02-776
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Warszawa, Poland, 04-141
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Łódź, Poland, 93-510
Russian Federation
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Pyatigorsk, Stravropol, Russian Federation, 357532
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Saint Petersburg, Russian Federation, 191024
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Saint Petersburg, Russian Federation, 197022
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Saint Petersburg, Russian Federation, 197341
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Saint Petersburg, Russian Federation, 198255
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Syktyvkar, Russian Federation, 167029
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Tula, Russian Federation, 300053
Spain
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Badalona, Spain, 08916
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Barcelona, Spain, 08003
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Barcelona, Spain, 08035
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Barcelona, Spain, 08041
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Barcelona, Spain, 08908
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Madrid, Spain, 28007
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Madrid, Spain, 28040
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Madrid, Spain, 28046
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Madrid, Spain, 28222
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Pamplona, Spain, 31008
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Sevilla, Spain, 41013
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Valencia, Spain, 46026
Taiwan
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Kaohsiung, Taiwan, 833
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Taichung, Taiwan, 404
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Taipei, Taiwan, 100
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Taipei, Taiwan, 112
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Taoyuan, Taiwan, 333
Ukraine
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Cherkasy, Ukraine, 18009
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Chernihiv, Ukraine, 14029
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Dnipro, Ukraine, 49102
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Kyiv, Ukraine, 03022
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Lviv, Ukraine, 79044
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Zhytomyr, Ukraine, 10002
Vietnam
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Hanoi, Vietnam, 123
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Hanoi, Vietnam, 123
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Hanoi, Vietnam
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Ho Chi Minh City, Vietnam, Ward 7
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Huế, Vietnam, Hue City
Sponsors and Collaborators
Acerta Pharma BV
Investigators
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Study Director: Acerta Pharma 1-888-292-9613 Acertamc@dlss.com

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Responsible Party: Acerta Pharma BV
ClinicalTrials.gov Identifier: NCT02972840     History of Changes
Other Study ID Numbers: ACE-LY-308
First Posted: November 25, 2016    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Acerta Pharma BV:
Bruton tyrosine kinase inhibitor
Acalabrutinib
Mantle Cell Lymphoma
ACE-LY-308
Treatment naive
non-Hodgkins Lymphoma
Bendomustine
Rituximab
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Bendamustine Hydrochloride
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action