A Study of Pinatuzumab Vedotin (DCDT2980S) Combined With Rituximab or Polatuzumab Vedotin (DCDS4501A) Combined With Rituximab or Obinutuzumab in Participants With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma

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 efficacy of pinatuzumab vedotin (DCDT2980S) or polatuzumab vedotin (DCDS4501A) in combination with rituximab (RTX), as well as a combination of polatuzumab vedotin with obinutuzumab in participants with relapsed or refractory follicular non-Hodgkin's lymphoma (NHL) and relapsed/refractory diffuse large B-cell lymphoma (DLBCL).

Trial Description

Primary Outcome:

  • Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
  • Percentage of Participants With a Best Overall Response (OR) of Complete Response (CR) or Partial Response (PR) as Determined by Modified Response and Progression Criteria for NHL: Rituximab-Containing Regimens [Arms A and B, Cohorts C to D]
  • Duration of Objective Response as Determined by Modified Response and Progression Criteria for NHL: Rituximab-Containing Regimens [Arms A and B, Cohorts C to D]
  • Percentage of Participants With CR at End of Treatment (EOT) Based on Positron Emission Tomographic (PET) Assessment as Determined by Independent Review Committee (IRC) per Lugano 2014 Response Criteria:Obinutuzumab-Containing Cohorts (Cohorts E,G and H)
Secondary Outcome:
  • Percentage of Participants With Anti-Therapeutic Antibodies (ATA) to Pinatuzumab Vedotin
  • Percentage of Participants With ATA to Polatuzumab Vedotin
  • Percentage of Participants With ATA to Obinutuzumab
  • Progression-free Survival (PFS) as Determined by Modified Response and Progression Criteria for NHL: Arms A and B, Cohorts C and D
  • Overall Survival (OS): Arms A and B, Cohorts C and D
  • Percentage of Participants With CR at EOT Based on Computed Tomography (CT) Assessment as Determined by IRC per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E, G, and H)
  • Percentage of Participants With CR at EOT Based on CT Assessment as Determined by Investigator per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E, G, and H)
  • Percentage of Participants With OR Based on PET Assessment as Determined by IRC per Lugano 2014 Response Criteria at EOT: Cohort E, G, H
  • Percentage of Participants With OR Based on PET Assessment as Determined by Investigator per Lugano 2014 Response Criteria at EOT: Cohort E, G, H
  • Percentage of Participants With OR Based on CT Assessment as Determined by the IRC per Lugano 2014 Response Criteria at EOT: Cohort E, G, H
  • Percentage of Participants With OR Based on CT Assessment as Determined by the Investigator per Lugano 2014 Response Criteria at EOT: Cohort E, G, H
  • Percentage of Participants With Best OR Based on PET Alone Assessment as Determined by the Investigator per Lugano 2014 Response Criteria During the Study: Cohort E, G, H
  • Percentage of Participants With Best OR Based on CT Alone Assessment as Determined by the Investigator per Lugano 2014 Response Criteria During the Study: Cohort E, G, H
  • Area Under the Concentration-Time Curve (AUC) of Rituximab
  • AUC of Polatuzumab Vedotin
  • AUC of Pinatuzumab Vedotin
  • AUC of Obinutuzumab
  • Maximum Observed Serum Concentration of Rituximab
  • Maximum Observed Plasma Concentration (Cmax) of Polatuzumab Vedotin
  • Cmax of Pinatuzumab Vedotin
  • Maximum Observed Serum Concentration of Obinutuzumab
  • Systemic Clearance (CL) of Rituximab
  • CL of Polatuzumab Vedotin
  • CL of Pinatuzumab Vedotin
  • CL of Obinutuzumab
  • Plasma Decay Half-Life (t1/2) of Rituximab
  • t1/2 of Polatuzumab Vedotin
  • t1/2 of Pinatuzumab Vedotin
  • t1/2 of Obinutuzumab
  • Volume of Distribution at Steady State (Vss) of Rituximab
  • Vss of Polatuzumab Vedotin
  • Vss of Pinatuzumab Vedotin
  • Vss of Obinutuzumab

View this trial on ClinicalTrials.gov

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Resources

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