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

Conditions

• Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bendamustine — DRUG
  Bendamustine 90 milligrams per meter-squared (mg/m\^2) per day administered IV on Days 2 and 3 of Cycle 1, then on Days 1 and 2 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
• Obinutuzumab — DRUG
  Obinutuzumab 1000 milligrams (mg) IV on Days 1, 8, and 15 of Cycle 1 and on Day 1 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
• Polatuzumab vedotin (Liquid) — DRUG
  Polatuzumab vedotin 1.8 milligrams per kilogram (mg/kg) administered IV on Day 2 of Cycle 1, then on Day 1 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
• Rituximab — DRUG
  Rituximab standard dose, 375 mg/m\^2 IV on Day 1 of each cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
• Polatuzumab vedotin (Lyophilized) — DRUG
  Participants in the New Formulation (NF) Cohort (Arms G and H) will follow the same schedule and dosing requirements as participants in the other Phase II cohorts (Arms A-F).

Study Details

This study is a multicenter, 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.

Key Dates

Start date

Oct 15, 2014

Status verified

Oct 2022

Primary completion

Oct 21, 2021

Completion

Oct 21, 2021

Study Design

Enrollment

331 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A (Phase II Randomization): Polatuzumab+BR in FL
  Polatuzumab vedotin will be administered with bendamustine and rituximab in participants with FL.
• Active Comparator: Arm B (Phase II Randomization): BR in FL
  Bendamustine and rituximab will be administered alone (that is, without polatuzumab vedotin) as a control arm in participants with FL.
• Experimental: Arm C (Phase II Randomization): Polatuzumab+BR in DLBCL
  Polatuzumab vedotin will be administered with bendamustine and rituximab in participants with DLBCL.
• Active Comparator: Arm D (Phase II Randomization): BR in DLBCL
  Bendamustine and rituximab will be administered alone (that is, without polatuzumab vedotin) as a control arm in participants with DLBCL.
• Experimental: Arm E (Phase II Expansion): Polatuzumab+BG in FL
  Polatuzumab vedotin will be administered with bendamustine and obinutuzumab in participants with FL.
• Experimental: Arm F (Phase II Expansion): Polatuzumab+BG in DLBCL
  Polatuzumab vedotin will be administered with bendamustine and obinutuzumab in participants with DLBCL.
• Experimental: Cohort 1A (Phase Ib Safety Run-In): Polatuzumab+BR in DLBCL
  Polatuzumab vedotin will be administered with bendamustine and rituximab in participants with DLBCL.
• Experimental: Cohort 1A (Phase Ib Safety Run-In): Polatuzumab+BR in FL
  Polatuzumab vedotin will be administered with bendamustine and rituximab in participants with FL.
• Experimental: Cohort 1B (Phase Ib Safety Run-In): Polatuzumab+BG in DLBCL
  Polatuzumab vedotin will be administered with bendamustine and obinutuzumab in participants with DLBCL.
• Experimental: Cohort 1B (Phase Ib Safety Run-In): Polatuzumab+BG in FL
  Polatuzumab vedotin will be administered with bendamustine and obinutuzumab in participants with FL.
• Experimental: Arm G (Phase II NF Cohort): Polatuzumab+BR in DLBCL
  In this New Formulation (NF) cohort, Polatuzumab vedotin (lyophilized) will be administered with bendamustine and rituximab in participants with DLBCL.
• Experimental: Arm H (Phase II NF Cohort): Polatuzumab+BR in DLBCL
  In this NF cohort, Polatuzumab vedotin (lyophilized) will be administered with bendamustine and rituximab in participants with DLBCL.

Primary Outcome Measure

Phase Ib: Percentage of Participants With Adverse Events (AEs) [ Time Frame: From the study start up to the end of the study (up to approximately 84 months) ]

Locations (16)

Find similar trials in Birmingham, AL

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