Non Hodgkin Lymphoma Clinical Trial

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)

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.


View Full Description

Full 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.


View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:


History of Non-Hodgkin’s Lymphoma (NHL) with relapsed or refractory disease

Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2


Exclusion Criteria:


Life expectancy ≤ 2 months

Received prior systemic anti-cancer treatment (approved or investigational) ≤ 5 half-lives or 4 weeks prior to starting CC-99282, whichever is shorter

Is on chronic systemic immunosuppressive therapy or corticosteroids or has clinically significant graft-versus-host disease (GVHD)

Impaired cardiac function or clinically significant cardiac disease


Other protocol-defined inclusion/exclusion criteria apply


Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

438

Study ID:

NCT03930953

Recruitment Status:

Recruiting

Sponsor:

Celgene

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There are 85 Locations for this study

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Mayo Clinic Arizona - Scottsdale
Scottsdale Arizona, 85259, United States More Info
Javier Munoz, Site 109
Contact
480-301-8000
UCSD Moores Cancer Center
La Jolla California, 92093, United States
Local Institution - 114
Los Angeles California, 90048, United States More Info
Site 114
Contact
University of California, Irvine
Orange California, 92848, United States
Oncology Institute of Hope and Innovation
Whittier California, 90603, United States
Mayo Clinic - Jacksonville
Jacksonville Florida, 32224, United States More Info
Muhamad Alhaj Moustafa, Site 111
Contact
904-953-2000
H Lee Moffitt Cancer Center
Tampa Florida, 32207, United States More Info
Julio Chavez, Site 102
Contact
813-745-8172
The University of Kansas - Clinical Research Center
Overland Park Kansas, 66210, United States
The University of Kansas - Clinical Research Center
Overland Park Kansas, 66210, United States More Info
Marc Hoffmann, Site 108
Contact
913-574-2650
University Of Maryland At Baltimore
Baltimore Maryland, 21201, United States
Mayo Clinic in Rochester, Minnesota
Rochester Minnesota, 55905, United States
Mayo Clinic in Rochester, Minnesota
Rochester Minnesota, 55905, United States More Info
Grzegorz Nowakowski, Site 107
Contact
507-284-2511
Washington University
Saint Louis Missouri, 63110, United States
Local Institution - 103
Hackensack New Jersey, 07601, United States
Perlmutter Cancer Center at NYU Langone Hospital-Long Island
Mineola New York, 11501, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Loretta Nastoupil, Site 101
Contact
713-745-4017
Hospital Aleman
Ciudad Autonoma de Buenos Aires Buenos Aires, C1118, Argentina More Info
Maria Clavijo, Site 255
Contact
5491132613344
Local Institution - 251
Ciudad autónoma de Buenos Aires Buenos Aires, 1280, Argentina
Local Institution - 254
Pilar Buenos Aires, 1629, Argentina More Info
Site 254
Contact
Local Institution - 250
Buenos Aires , C1426, Argentina
Local Institution - 253
Buenos Aires , , Argentina More Info
Site 253
Contact
Local Institution - 252
Cordoba , 5016, Argentina
Local Institution - 701
Salzburg , 5020, Austria More Info
Site 701
Contact
Local Institution - 704
St. Polten , 3100, Austria More Info
Site 704
Contact
Local Institution - 703
Vienna , 1090, Austria More Info
Site 703
Contact
Local Institution - 903
Edegem , 2650, Belgium
Local Institution - 901
Leuven , 3000, Belgium
Local Institution - 902
Leuven , 3000, Belgium
Hospital São Lucas da PUCRS
Porto Alegre Rio Grande Do Sul, 90610, Brazil More Info
Mariza Schaan, Site 453
Contact
55 5133203319
Hospital israelita Albert Einstein
Sao Paulo Sp, 05651, Brazil More Info
Guilherme Fleury Perini, Site 450
Contact
Instituto D'Or de Pesquisa e Ensino
São Paulo , 04501, Brazil More Info
Eduardo Magalhaes Rego, Site 451
Contact
+551636022888
Local Institution - 452
São Paulo , 12460, Brazil More Info
Site 452
Contact
Local Institution - 203
Edmonton Alberta, T6G1Z, Canada
Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada More Info
John Kuruvilla, Site 201
Contact
4169464501ext2821
Clínica Inmunocel
Santiago Metropolitana DE Santiago, 75802, Chile More Info
Alejandro Berkovits, Site 354
Contact
997890202
Bradford Hill
Recoleta Metropolitana, 842 0, Chile More Info
Sergio Portiño, Site 355
Contact
56998467083
Fundacion Oncologia Arturo Lopez Perez
Santiago Metropolitana, 75009, Chile More Info
Raimundo Gazitua, Site 353
Contact
+56984290128
Local Institution - 352
Santiago Metropolitana, 83200, Chile More Info
Site 352
Contact
Centro de Oncologia de Precision
Santiago RM, 75609, Chile More Info
Marcelo Garrido, Site 350
Contact
Local Institution - 0909
Santiago , 75910, Chile
Local Institution - 351
Santiago , 838-0, Chile
Peking University Third Hospital
Beijing Beijing, 10002, China More Info
Hongmei Jing, Site 653
Contact
Local Institution - 656
Xiamen Fujian, 36100, China
Guangdong Provincial People's Hospital
Guangzhou Guangdong, 51008, China More Info
Wenyu Li, Site 657
Contact
86-13924196915
Local Institution - 652
Haerbin Heilongjiang, 15008, China
Henan Cancer Hospital
Zhengzhou Henan, 45000, China More Info
Keshu Zhou, Site 655
Contact
Hubei Cancer Hospital
Wuhan Shi Hubei, 43007, China More Info
Huijing Wu, Site 660
Contact
The First Affiliated Hospital of China Medical University
Shenyang Liaoning, 11000, China More Info
Xiaojing Yan, Site 662
Contact
13889128302
Shengjing Hospital of China Medical University
Shenyang Liaoning, 11002, China More Info
wei yang, Site 663
Contact
18940251012
Local Institution - 650
Shanghai Shanghai, 20002, China More Info
Site 650
Contact
Tianjin Medical University Cancer Institute and Hospital
Tianjin Tianjin, 30006, China More Info
Lihua Qiu, Site 651
Contact
Local Institution - 654
Hangzhou Zhejiang, 31005, China
Sun Yat-sen University Cancer Center
Guangzhou , 51006, China More Info
Huiqiang Huang, Site 659
Contact
8613808885154
Local Institution - 658
Guangzhou , 51051, China
Aarhus University Hospital
Aarhus , 8200, Denmark More Info
Judit Meszaros Joergensen, Site 602
Contact
+4578465130
Local Institution - 601
Copenhagen , 2100, Denmark More Info
Site 601
Contact
Local Institution - 603
Vejle , 7100, Denmark More Info
Site 603
Contact
Institut Bergonie Centre Regional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest
Bordeaux , 33076, France More Info
Fontanet Bijou, Site 407
Contact
33556333333
Hopital Henri Mondor
Creteil , 94010, France More Info
Corinne Haioun, Site 403
Contact
+33149812151
Chru De Lille - Hopital Claude Huriez
Lillie Cedex , 59037, France More Info
Franck Morschhauser, Site 406
Contact
33320445713
Local Institution - 0904
Montpellier CEDEX 5 , 34295, France
CHU Montpellier - Hopital St Eloi
Montpellier , 34295, France More Info
Guillaume Cartron, Site 409
Contact
+33675926918
Hopital Saint-Louis
Paris , 75010, France More Info
Catherine Thieblemont, Site 405
Contact
33142499236
Centre Hospitalier Lyon-Sud
Pierre-Benite CEDEX , 69495, France More Info
Emmanuel Bachy, Site 402
Contact
33478862286
Centre Henri Becquerel
Rouen , 76038, France More Info
Fabrice JARDIN, Site 404
Contact
Institut Claudius Regaud, IUCT-Oncopole
Toulouse , 31200, France More Info
Pierre Bories, Site 408
Contact
33531156514
Gustave Roussy
Villejuif CEDEX , 94805, France More Info
Vincent Ribrag, Site 401
Contact
33142114507
Local Institution - 150
Jerusalem , 91120, Israel More Info
Site 150
Contact
Local Institution - 151
Petah Tikva , 49100, Israel More Info
Site 151
Contact
Local Institution - 152
Ramat Gan , 52621, Israel More Info
Site 152
Contact
Local Institution - 501
Bergamo , 24127, Italy More Info
Site 501
Contact
Local Institution - 504
Bologna , 40138, Italy More Info
Site 504
Contact
Local Institution - 503
Milano , 20162, Italy More Info
Site 503
Contact
Local Institution - 502
Napoli , 80131, Italy More Info
Site 502
Contact
Local Institution - 506
Pavia , 27100, Italy More Info
Site 506
Contact
Local Institution - 505
Rozzano , 20089, Italy
Local Institution - 507
Verona , 37134, Italy
Inje University Busan Paik Hospital
Busan , 47392, Korea, Republic of More Info
Won-Sik Lee, Site 553
Contact
82-51-890-8849
Seoul National University Hospital
Seoul , 03080, Korea, Republic of More Info
Sung-Soo Yoon, Site 551
Contact
+821047546706
Samsung Medical Center
Seoul , 06351, Korea, Republic of More Info
Won-Seog Kim, Site 550
Contact
8223410654800000
Local Institution - 552
Seoul , 06591, Korea, Republic of More Info
Site 552
Contact
Local Institution - 306
Badalona (Barcelona) , 08916, Spain More Info
Site 306
Contact
Local Institution - 301
Barcelona , 08035, Spain More Info
Site 301
Contact
Local Institution - 302
Madrid , 28040, Spain More Info
Site 302
Contact
Local Institution - 304
Madrid , 28046, Spain More Info
Site 304
Contact
Hospital Universitario Virgen De La Victoria
Malaga , 29010, Spain More Info
Antonio Rueda-Domínguez, Site 303
Contact
+34951032467 00 000
Local Institution - 305
Salamanca , 37007, Spain More Info
Site 305
Contact
Local Institution - 0905
Belfast Northern Ireland , BT9 7, United Kingdom
Local Institution - 805
Belfast Northern Ireland , BT9 7, United Kingdom
Local Institution - 802
Edinburgh Scotland , EH4 2, United Kingdom More Info
Site 802
Contact
Local Institution - 803
Southhampton , SO01 , United Kingdom More Info
Site 803
Contact

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

438

Study ID:

NCT03930953

Recruitment Status:

Recruiting

Sponsor:


Celgene

How clear is this clinincal trial information?

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