Spots Global Cancer Trial Database for A Safety and Preliminary Efficacy Study of CC-99282, Alone and in Combination With Anti-lymphoma Agents in Participants With Relapsed or Refractory Non-Hodgkin Lymphomas (R/R NHL)
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Trial Identification
Brief Title: A Safety and Preliminary Efficacy Study of CC-99282, Alone and in Combination With Anti-lymphoma Agents in Participants With Relapsed or Refractory Non-Hodgkin Lymphomas (R/R NHL)
Official Title: A Phase 1/2, Multi-center, Open-label Study to Assess the Safety, Pharmacokinetics, and Preliminary Efficacy of an Orally Available Small Molecule, CC-99282, Alone and in Combination With Anti-Lymphoma Agents in Subjects With Relapsed or Refractory Non-Hodgkin Lymphomas (R/R NHL).
Study ID: NCT03930953
Conditions
Study Description
Brief Summary: The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of CC-99282 alone and in combination with anti-lymphoma agents in participants with relapsed or refractory non-Hodgkin's lymphomas.
Detailed Description: Participants with relapsed or refractory non-Hodgkin's lymphomas (R/R NHL) who have failed at least 2 lines of therapy (or have received at least one prior line of standard therapy and are not eligible for any other therapy). The dose escalation will evaluate the safety and tolerability of escalating doses of CC-99282 in relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) and/or relapsed or refractory follicular lymphoma (R/R FL) participants to determine the maximum tolerated dose (MTD) of CC-99282 as monotherapy. The dose expansion will further evaluate the safety and preliminary efficacy of single agent CC-99282 or the safety and preliminary efficacy of CC-99282 in combination with anti-lymphoma agents in participants with R/R DLBCL and NHL. Part B Cohort B will further evaluate the potential effects of food on the PK and safety of CC-99282.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic Arizona - Scottsdale, Scottsdale, Arizona, United States
UCSD Moores Cancer Center, La Jolla, California, United States
Local Institution - 114, Los Angeles, California, United States
University of California, Irvine, Orange, California, United States
Oncology Institute of Hope and Innovation, Whittier, California, United States
Mayo Clinic - Jacksonville, Jacksonville, Florida, United States
H Lee Moffitt Cancer Center, Tampa, Florida, United States
The University of Kansas - Clinical Research Center, Overland Park, Kansas, United States
The University of Kansas - Clinical Research Center, Overland Park, Kansas, United States
University Of Maryland At Baltimore, Baltimore, Maryland, United States
Mayo Clinic in Rochester, Minnesota, Rochester, Minnesota, United States
Mayo Clinic in Rochester, Minnesota, Rochester, Minnesota, United States
Washington University, Saint Louis, Missouri, United States
Local Institution - 103, Hackensack, New Jersey, United States
Perlmutter Cancer Center at NYU Langone Hospital-Long Island, Mineola, New York, United States
MD Anderson Cancer Center, Houston, Texas, United States
Hospital Aleman, Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 251, Ciudad autónoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 254, Pilar, Buenos Aires, Argentina
Local Institution - 250, Buenos Aires, , Argentina
Local Institution - 253, Buenos Aires, , Argentina
Local Institution - 252, Cordoba, , Argentina
Local Institution - 701, Salzburg, , Austria
Local Institution - 704, St. Polten, , Austria
Local Institution - 703, Vienna, , Austria
Local Institution - 903, Edegem, , Belgium
Local Institution - 901, Leuven, , Belgium
Local Institution - 902, Leuven, , Belgium
Hospital São Lucas da PUCRS, Porto Alegre, Rio Grande Do Sul, Brazil
Hospital israelita Albert Einstein, Sao Paulo, Sp, Brazil
Instituto D'Or de Pesquisa e Ensino, São Paulo, , Brazil
Local Institution - 452, São Paulo, , Brazil
Local Institution - 203, Edmonton, Alberta, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Clínica Inmunocel, Santiago, Metropolitana DE Santiago, Chile
Bradford Hill, Recoleta, Metropolitana, Chile
Fundacion Oncologia Arturo Lopez Perez, Santiago, Metropolitana, Chile
Local Institution - 352, Santiago, Metropolitana, Chile
Centro de Oncologia de Precision, Santiago, RM, Chile
Local Institution - 0909, Santiago, , Chile
Local Institution - 351, Santiago, , Chile
Peking University Third Hospital, Beijing, Beijing, China
Local Institution - 656, Xiamen, Fujian, China
Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China
Local Institution - 652, Haerbin, Heilongjiang, China
Henan Cancer Hospital, Zhengzhou, Henan, China
Hubei Cancer Hospital, Wuhan Shi, Hubei, China
The First Affiliated Hospital of China Medical University, Shenyang, Liaoning, China
Shengjing Hospital of China Medical University, Shenyang, Liaoning, China
Local Institution - 650, Shanghai, Shanghai, China
Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tianjin, China
Local Institution - 654, Hangzhou, Zhejiang, China
Sun Yat-sen University Cancer Center, Guangzhou, , China
Local Institution - 658, Guangzhou, , China
Aarhus University Hospital, Aarhus, , Denmark
Local Institution - 601, Copenhagen, , Denmark
Local Institution - 603, Vejle, , Denmark
Institut Bergonie Centre Regional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest, Bordeaux, , France
Hopital Henri Mondor, Creteil, , France
Chru De Lille - Hopital Claude Huriez, Lillie Cedex, , France
Local Institution - 0904, Montpellier CEDEX 5, , France
CHU Montpellier - Hopital St Eloi, Montpellier, , France
Hopital Saint-Louis, Paris, , France
Centre Hospitalier Lyon-Sud, Pierre-Benite CEDEX, , France
Centre Henri Becquerel, Rouen, , France
Institut Claudius Regaud, IUCT-Oncopole, Toulouse, , France
Gustave Roussy, Villejuif CEDEX, , France
Local Institution - 150, Jerusalem, , Israel
Local Institution - 151, Petah Tikva, , Israel
The Edmond and Lily Safra Children's Hospital The Chaim Sheba Medical Center Department of Pediatric Hemato-Oncology, Ramat Gan, , Israel
Azienda Ospedaliera Papa Giovanni Xxiii, Bergamo, , Italy
Azienda Ospedaliero Universitaria di Bologna, Bologna, , Italy
Local Institution - 503, Milano, , Italy
Local Institution - 502, Napoli, , Italy
Local Institution - 506, Pavia, , Italy
Local Institution - 505, Rozzano, , Italy
Local Institution - 507, Verona, , Italy
Inje University Busan Paik Hospital, Busan, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
The Catholic University of Korea, Seoul St. Marys Hospital, Seoul, , Korea, Republic of
Local Institution - 306, Badalona (Barcelona), , Spain
Vall d Hebron University Hospital, Barcelona, , Spain
Hospital Universitario Fundación Jiménez Díaz-Oncology & Hematology, Madrid, , Spain
Local Institution - 304, Madrid, , Spain
Hospital Universitario Virgen De La Victoria, Malaga, , Spain
Local Institution - 305, Salamanca, , Spain
Local Institution - 0905, Belfast Northern Ireland, , United Kingdom
Local Institution - 805, Belfast Northern Ireland, , United Kingdom
Western General Hospital, Edinburgh Scotland, , United Kingdom
Southampton General Hospital, Southhampton, , United Kingdom
Contact Details
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR
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