A Study of Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab or Obinutuzumab Plus Bendamustine in Participants With Relapsed or Refractory Follicular or Diffuse Large B-Cell Lymphoma

Official Title

A Phase IB/II Study Evaluating The Safety, Tolerability and Anti-Tumour Activity of Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab (R) or Obinutuzumab (G) Plus Bendamustine (B) in Relapsed or Refractory Follicular or Diffuse Large B-Cell Lymphoma

Summary:

This study is a multicentre, open-label study of polatuzumab vedotin administered by intravenous (IV) infusion in combination with standard doses of bendamustine (B) and rituximab (R) or obinutuzumab (G) in participants with relapsed or refractory follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL). The study comprises two stages: a Phase Ib safety run-in stage and a Phase II stage. The anticipated time on treatment is 18 weeks for participants with DLBCL and 24 weeks for participants with FL.

Trial Description

Primary Outcome:

  • Phase Ib: Percentage of Participants with Adverse Events
  • Phase II: Percentage of Participants with Complete Response (CR) According to Modified Lugano Criteria as Measured by Positron Emission Tomography (PET)/Computed Tomography (CT) Scan and Determined by Independent Review Committee (IRC)
Secondary Outcome:
  • Percentage of Participants with CR According to Modified Lugano Criteria as Measured by PET/CT Scan and Determined by the Investigator
  • Percentage of Participants with CR or Partial Response (PR) According to Modified Lugano Criteria as Measured by PET/CT Scan and Determined by IRC and Investigator
  • Percentage of Participants with CR According to Modified Lugano Criteria as Measured by CT Scan and Determined by IRC and Investigator
  • Percentage of Participants with CR or PR According to Modified Lugano Criteria as Measured by CT Scan and Determined by IRC and Investigator
  • Percentage of Participants by Best Objective Response (BOR) According to Modified Lugano Criteria as Measured by PET/CT Scan or CT Scan only and Determined by the Investigator
  • Phase II: Percentage of Participants with Adverse Events
  • Phase Ib: Percentage of Participants with Anti-Drug Antibodies (ADAs) to Polatuzumab in Cohort 1A
  • Phase Ib: Percentage of Participants with ADAs to Polatuzumab and Obinutuzumab in Cohort 1B
  • Phase II: Percentage of Participants with ADAs to Polatuzumab in Arms A and C
  • Phase II: Percentage of Participants with ADAs to Polatuzumab and Obinutuzumab in Arms E and F
  • Pharmacokinetics: Maximum Concentration (Cmax) of Polatuzumab, Bendamustine, and Rituximab in Cohort 1A (milligrams per milliliter [mg/mL])
  • Pharmacokinetics: Cmax of Polatuzumab, Bendamustine, and Obinutuzumab in Cohort 1B (mg/mL)
  • Pharmacokinetics: Area Under Concentration-Time Curve (AUC) of Polatuzumab, Bendamustine, and Rituximab in Cohort 1A (hour * milligrams per milliliter [h*mg/mL])
  • Pharmacokinetics: AUC of Polatuzumab, Bendamustine, and Obinutuzumab in Cohort 1B (h*mg/mL)
  • Pharmacokinetics: Cmax of Polatuzumab, Bendamustine, and Rituximab in Arms A and C (mg/mL)
  • Pharmacokinetics: AUC of Polatuzumab, Bendamustine, and Rituximab in Arms A and C (h*mg/mL)
  • Pharmacokinetics: Cmax of Bendamustine and Rituximab in Arms B and D (mg/mL)
  • Pharmacokinetics: AUC of Bendamustine and Rituximab in Arms B and D (h*mg/mL)
  • Pharmacokinetics: Cmax of Polatuzumab, Bendamustine, and Obinutuzumab in Arms E and F (mg/mL)
  • Pharmacokinetics: AUC of Polatuzumab, Bendamustine, and Obinutuzumab in Arms E and F (h*mg/mL)
  • Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS)

View this trial on ClinicalTrials.gov

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Resources

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