A Study to Evaluate the Safety and Efficacy of Polatuzumab Vedotin in Combination With Rituximab, Gemcitabine and Oxaliplatin Compared to Rituximab, Gemcitabine and Oxaliplatin Alone in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Hoffmann-La Roche
Study ID
NCT04182204
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Polatuzumab Vedotin — DRUG
    Polatuzumab vedotin 1.8 mg/kg for a maximum dose of 240 mg/cycle IV on Day 1 of each 21-day cycle for up to 8 cycles.
  • Rituximab — DRUG
    Rituximab 375 mg/m2 IV on Day 1 of each 21-day cycle for up to 8 cycles.
  • Gemcitabine — DRUG
    Gemcitabine 1000 mg/m2 IV on Day 2 of each 21-day cycle for up to 8 cycles.
  • Oxaliplatin — DRUG
    Oxaliplatin 100 mg/m2 IV on Day 2 of each 21-day cycle for up to 8 cycle.

Study Details

This study is a multicenter, open-label study of polatuzumab vedotin administered by intravenous (IV) infusion in combination with rituximab, gemcitabine and oxaliplatin (R-GemOx) in participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The study comprises of two stages: a safety run-in stage and a randomized controlled trial (RCT).

Key Dates

Start date
Feb 7, 2020
Status verified
Dec 2025
Primary completion
Nov 29, 2024
Completion
Nov 29, 2024

Study Design

Enrollment
270 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pola-R-GemOx (Stage 1)
    Participants will receive polatuzumab vedotin 1.8 milligrams per kilogram (mg/kg) for a maximum dose of 240 mg per cycle (mg/cycle) administered intravenously (IV) and rituximab 375 milligrams per square meter (mg/m\^2) administered IV on Day 1. Participants will receive gemcitabine 1000 mg/m\^2 administered IV and oxaliplatin 100 mg/m\^2 administered IV on Day 2. Each cycle will consist of 21 days with up to 8 cycles of treatment administration.
  • Experimental: Pola-R-GemOx (Stage 2)
    Participants will receive polatuzumab vedotin 1.8 mg/kg for a maximum dose of 240 mg/cycle administered IV and rituximab 375 mg/m\^2 administered IV on Day 1. Participants will receive gemcitabine 1000 mg/m\^2 administered IV and oxaliplatin 100 mg/m\^2 administered IV on Day 2. Each cycle will consist of 21 days with up to 8 cycles of treatment administration.
  • Active Comparator: R-GemOx (Stage 2)
    Participants will receive rituximab 375 mg/m\^2 administered IV on Day 1. Participants will receive gemcitabine 1000 mg/m\^2 administered IV and oxaliplatin 100 mg/m\^2 administered IV on Day 2. Each cycle will consist of 21 days with up to 8 cycles of treatment administration.

Primary Outcome Measure

Stage 1: Number of Participants With Adverse Events (AEs) [ Time Frame: From treatment initiation until 90 days after the last dose of study drug or initiation of non-protocol-specified anti-lymphoma treatment (NALT) (Up to approximately 8.3 months) ]

Locations (7)

FacilityCityStateZIPSite coordinators
Cancer SpecialistsJacksonvilleFlorida32256-
Memorial Cancer Institute at Memorial WestPembroke PinesFlorida33028-
IHA Hematology Oncology Consultants - Ann ArborAnn ArborMichigan48106-
MSKCC at Basking RidgeBasking RidgeNew Jersey07920-
Memorial Sloan Kettering Cancer Center at BergenMontvaleNew Jersey07645-
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065-
Memorial Sloan Kettering NassauUniondaleNew York11553-

Find similar trials in Jacksonville, FL

By research site
Cancer Specialists· Jacksonville, FLMemorial Cancer Institute at Memorial West· Pembroke Pines, FLIHA Hematology Oncology Consultants - Ann Arbor· Ann Arbor, MIMSKCC at Basking Ridge· Basking Ridge, NJMemorial Sloan Kettering Cancer Center at Bergen· Montvale, NJMemorial Sloan-Kettering Cancer Center· New York, NY

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