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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).
Description
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 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
Trial Eligibility
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 Info
Organization
Celgene
Primary Outcome
Incidence of Adverse Events (AEs)
Interventions
Locations Recruiting
Mayo Clinic Arizona - Scottsdale
United States, Arizona, Scottsdale
UCSD Moores Cancer Center
United States, California, La Jolla
Local Institution - 114
United States, California, Los Angeles
University of California, Irvine
United States, California, Orange
Oncology Institute of Hope and Innovation
United States, California, Whittier
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