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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)


Outcome Timeframe From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)

NCTID NCT03930953

Phases PHASE1,PHASE2

Primary Purpose TREATMENT

Start Date 2019-05-20

Completion Date 2026-04-17

Enrollment Target 438

Interventions

DRUG CC-99282

DRUG Rituximab

DRUG Obinutuzumab

DRUG Tafasitamab

DRUG Valemetostat

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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