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) ≤ 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:

387

Study ID:

NCT03930953

Recruitment Status:

Recruiting

Sponsor:

Celgene

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There are 74 Locations for this study

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Mayo Clinic Arizona - Scottsdale
Scottsdale Arizona, 85259, United States More Info
Javier Munoz, Site 109
Contact
480-203-6378
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
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 More Info
Seung Tae Lee, Site 113
Contact
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
507-266-4972
Washington University
Saint Louis Missouri, 63110, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States More Info
Tatyana Feldman, Site 103
Contact
973-699-2835
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
Local Institution - 255
Ciudad Autonoma de Buenos Aires Buenos Aires, C1118, Argentina More Info
Site 255
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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
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Local Institution - 252
Cordoba , 5016, Argentina
Local Institution - 701
Salzburg , 5020, Austria More Info
Site 701
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Local Institution - 704
Sankt Pölten , 3100, Austria More Info
Site 704
Contact
Local Institution - 703
Vienna , 1090, Austria More Info
Site 703
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Local Institution - 903
Edegem , 2650, Belgium
Local Institution - 902
Leuven , 3000, Belgium More Info
Site 902
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Local Institution - 453
Porto Alegre Rio Grande Do Sul, 90610, Brazil More Info
Site 453
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Local Institution - 450
Sao Paulo Sp, 05651, Brazil More Info
Site 450
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Local Institution - 452
Sao Paulo , 01246, Brazil More Info
Site 452
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Local Institution - 451
São Paulo , 04501, Brazil More Info
Site 451
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Local Institution - 203
Edmonton Alberta, T6G1Z, Canada
Local Institution - 201
Toronto Ontario, M5G 2, Canada More Info
Site 201
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Local Institution - 350
Las Condes Arica Y Parinacota, 75609, Chile More Info
Site 350
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Local Institution - 355
Recoleta Metropolitana, 842 0, Chile More Info
Site 355
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Local Institution - 354
Santiago de Chile Metropolitana, 75006, Chile More Info
Site 354
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Local Institution - 353
Santiago Metropolitana, 75009, Chile More Info
Site 353
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Local Institution - 352
Santiago Metropolitana, 83200, Chile More Info
Site 352
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Local Institution - 0909
Santiago , 75910, Chile
Local Institution - 351
Santiago , 838-0, Chile
Local Institution - 652
Haerbin Heilongjiang, 15008, China
Local Institution - 654
Hangzhou Zhejiang, 31005, China
Local Institution - 602
Aarhus , 8200, Denmark More Info
Site 602
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Local Institution - 601
Copenhagen , 2100, Denmark More Info
Site 601
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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
+33556337801
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
CHU Montpellier - Hôpital Saint Eloi
Montpellier CEDEX 5 , 34295, France More Info
Guillaume Cartron, Site 409
Contact
+33675926918
Local Institution - 0904
Montpellier CEDEX 5 , 34295, France
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 , 31059, 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
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Local Institution - 151
Petah Tikva , 49100, Israel More Info
Site 151
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Local Institution - 152
Ramat Gan , 52621, Israel More Info
Site 152
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Local Institution - 501
Bergamo , 24127, Italy More Info
Site 501
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Local Institution - 504
Bologna , 40138, Italy More Info
Site 504
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Local Institution - 503
Milano , 20162, Italy More Info
Site 503
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Local Institution - 502
Napoli , 80131, Italy More Info
Site 502
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Local Institution - 506
Pavia , 27100, Italy More Info
Site 506
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Local Institution - 505
Rozzano , 20089, Italy
Local Institution - 507
Verona , 37134, Italy
Local Institution - 553
Busan , 47392, Korea, Republic of More Info
Site 553
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Local Institution - 551
Seoul , 03080, Korea, Republic of More Info
Site 551
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Local Institution - 550
Seoul , 06351, Korea, Republic of More Info
Site 550
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Local Institution - 552
Seoul , 06591, Korea, Republic of More Info
Site 552
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Local Institution - 306
Badalona (Barcelona) , 08916, Spain More Info
Site 306
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Local Institution - 301
Barcelona , 08035, Spain More Info
Site 301
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Local Institution - 302
Madrid , 28040, Spain More Info
Site 302
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Local Institution - 304
Madrid , 28046, Spain More Info
Site 304
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Local Institution - 303
Malaga , 29010, Spain More Info
Site 303
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Local Institution - 305
Salamanca , 37007, Spain More Info
Site 305
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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
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Local Institution - 803
Southhampton , SO01 , United Kingdom More Info
Site 803
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How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

387

Study ID:

NCT03930953

Recruitment Status:

Recruiting

Sponsor:


Celgene

How clear is this clinincal trial information?

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