Not currently recruiting at UCSD

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)

a study on Hodgkin's Lymphoma Lymphoma Non-Hodgkin Lymphoma

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion

Description

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.

Official Title

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).

Details

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.

Keywords

Lymphoma, Non-Hodgkin, Non-Hodgkin Lymphomas (NHL), Safety, Efficacy, CC-99282, Rituximab, Relapsed, Refractory, Pharmacokinetics, Obinutuzumab, Tafasitamab, Tazemetostat, Anti-lymphoma agents, Lymphoma, Non-Hodgkin Lymphoma

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • UCSD Moores Cancer Center not yet accepting patients
    La Jolla California 92093 United States
  • University of California, Irvine withdrawn
    Orange California 92848 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Celgene
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting FDA Safety Alerts and Recalls Investigator Inquiry Form
ID
NCT03930953
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 387 study participants
Last Updated