NCT03930953
Recruiting
April 29, 2019
February 8, 2022
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.
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 administered at or below MTD in subjects with R/R DLBCL and NHL. Part B will also evaluate the safety and preliminary efficacy of CC-99282 in combination with anti-lymphoma agents in participants with R/R DLBCL and R/R FL.
Arm | Intervention/treatment |
---|---|
Experimental: Part A: Dose Escalation |
Drug: CC-99282 Specified dose on specified days |
Experimental: Part B: Dose Expansion |
Drug: CC-99282 Specified dose on specified days Drug: Rituximab Specified dose on specified days Drug: Obinutuzumab Specified dose on specified days Drug: Tafasitamab Specified dose on specified days Drug: Tazemetostat Specified dose on specified days |
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com 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
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain the NCT# and Site #.
United States, California
University of California, Irvine
Orange
United States, Florida
H Lee Moffitt Cancer Center
Tampa
United States, Missouri
Washington University
Saint Louis
United States, New Jersey
Hackensack University Medical Center
Hackensack
United States, Texas
MD Anderson Cancer Center
Houston
Austria
LKH - Universitätsklinikum der PMU Salzburg
Salzburg
Austria
Universitätsklinikum St. Pölten
Sankt Pölten
Austria
Medical University Vienna
Vienna
Belgium
UZ Antwerpen
Edegem
Belgium
UZ Leuven
Leuven
Canada, Alberta
Cross Cancer Institute University of Alberta
Edmonton
Canada, Ontario
Princess Margaret Cancer Centre
Toronto
Canada
McGill University Health Centre MUHC
Montreal
Denmark
Aarhus University Hospital
Aarhus C
Denmark
Rigshospitalet University Hospital
Copenhagen
Denmark
Vejle Hospital
Vejle
France
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
Centre Hospitalier Lyon-Sud
Pierre-Benite CEDEX
France
Centre Henri Becquerel
Rouen
France
Institut Claudius Regaud, IUCT-Oncopole
Toulouse
France
Gustave Roussy
Villejuif CEDEX
Italy
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo
Italy
ASST Grande Ospedale Metropolitano Niguarda, Milano
Milano
Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori "Fondazione Giovanni Pascale"
Napoli
Spain
Hospital Universitari Germans Trias i Pujol Can Ruti
Badalona (Barcelona)
Spain
Vall d´Hebron University Hospital
Barcelona
Spain
Fundacion Jimenez Daaz
Madrid
Spain
Hospital La Paz
Madrid
Spain
Hospital Universitario Virgen De La Victoria
Malaga
Spain
Hospital Universitario de Salamanca
Salamanca
United Kingdom
Western General Hospital
Edinburgh Scotland
United Kingdom
University College London Hospitals NHS Foundation Trust - University College Hospital
London
United Kingdom
Southampton General Hospital
Southhampton
Celgene
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb