A Safety and Efficacy Study of Pinatuzumab Vedotin (DCDT2980S) Combined With Rituximab (MabThera/Rituxan) or Polatuzumab Vedotin (DCDS4501A) Combined With Rituximab and Polatuzumab Vedotin Combined With Obinutuzumab in Participants With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma (ROMULUS)

Official Title

A Randomized, Open Label, Multicentre, Phase II Trial Evaluating the Safety and Activity of Pinatuzumab Vedotin (DCDT2980S) in Combination With Rituximab or Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab and a Non-Randomized Phase Ib/II Evaluation of Polatuzumab Vedotin in Combination With Obinutuzumab in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma

Summary:

This multicentre, open-label study will evaluate the safety and the efficacy of Pinatuzumab Vedotin (DCDT2980S) in combination with rituximab (MabThera/Rituxan) or Polatuzumab Vedotin (DCDS4501A) in combination with rituximab, as well as a combination of Polatuzumab Vedotin with obinutuzumab in participants with relapsed or refractory follicular non-Hodgkin's lymphoma and relapsed/refractory diffuse large B-cell lymphoma.

Trial Description

Primary Outcome:

  • Duration of Objective Response
  • Number of Participants With Complete Response (CR) Based on Positron Emission Tomographic (PET) Assessment
  • Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
  • Number of Participants With Objective Response
Secondary Outcome:
  • Systemic Clearance (CL)
  • Plasma Decay Half-Life (t1/2)
  • Volume of Distribution at Steady State (Vss)
  • Number of Participants With Anti-Drug Antibody
  • Progression-free Survival (PFS)
  • Overall Survival (OS)
  • Number of Participants With Complete Response (CR) Based on Computed Tomography (CT) Assessment
  • Number of Participants With Objective Response (CR+PR) Based on PET and CT Assessments
  • Number of Participants With Best Overall Response Based on PET and CT Assessments
  • Area under the Concentration-Time Curve (AUC)
  • Maximum Observed Plasma Concentration (Cmax)

View this trial on ClinicalTrials.gov

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Resources

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