A Safety and Preliminary Efficacy Study of CC-99282, Alone and in Combination With Rituximab in Subjects With Relapsed or Refractory Non-hodgkin Lymphomas (R/R NHL)

Official Title

A Phase 1, Multi-centre, Open-label, Study to Assess the Safety, Pharmacokinetics, and Preliminary Efficacy of an Orally Available Small Molecule CC-99282 Alone and in Combination With Rituximab in Subjects With Relapsed or Refractory Non-Hodgkin Lymphoma (R/R iNHL).

Summary:

CC-99282-NHL-001 study is a Phase I dose escalation and expansion clinical study of CC-99282 administered alone and in combination with rituximab in subjects with relapsed or refractory non-hodgkin Lymphomas (R/R NHL).

Trial Description

Primary Outcome:

  • Dose Limiting Toxicity (DLT)
  • Maximum tolerated dose (MTD)
  • Adverse Events (AEs)
Secondary Outcome:
  • Pharmacokinetics - Cmax
  • Pharmacokinetics - AUC
  • Pharmacokinetics - Tmax
  • Pharmacokinetics - t1/2
  • Pharmacokinetics - CL/F
  • Pharmacokinetics - V/F
  • Objective response rate (ORR)
  • Time to response (TTR)
  • Duration of response (DoR)
  • Progression free survival
  • Overall survival
Subjects with 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 R/R DLBCL and/or R/R FL subjects to determine the 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 rituximab in subjects with R/R DLBCL and R/R FL.

View this trial on ClinicalTrials.gov

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Resources

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