Polatuzumab Vedotin Plus Rituximab, Ifosfamide, Carboplatin and Etoposide (Pola-R-ICE) Versus R-ICE Alone in Second Line Treatment of Diffuse Large B-cell Lymphoma (DLBCL)

Sponsor
GWT-TUD GmbH
Study ID
NCT04833114
Phase
PHASE3
Status
Completed

Conditions

  • Refractory Diffuse Large B-Cell Lymphoma
  • Relapsed Diffuse Large B-cell Lymphoma

Eligibility Criteria

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

Interventions

  • Polatuzumab Vedotin — DRUG
    Polatuzumab vedotin 1.8 mg/kg will be administered intravenously on Day 1 of each 21-day cycle for up to 3 cycles.
  • Mabthera — DRUG
    Rituximab (Mabthera/Rituxan®) will be administered as per local practice at a dose of 375 mg/m2 intravenously on Day 1 of each 21-day cycle for up to 3 cycles.
  • Ifosfamide — DRUG
    Ifosfamide 5000 mg/m² will be administered i.v. over a 24 hr period starting on cycle Day 2.
  • Carboplatin — DRUG
    Carboplatin AUC 5 max 800 mg will be administered i.v. on cycle Day 2.
  • Etoposide — DRUG
    Etoposide 100 mg/m² will be administered i.v. on cycle Days 1, 2 and 3.

Study Details

An open-label, prospective Phase III clinical study to compare polatuzumab vedotin plus rituximab, ifosfamide, carboplatin and etoposide (Pola-R-ICE) with rituximab, ifosfamide, carboplatin and etoposide (R-ICE) alone as salvage therapy in patients with primary refractory or relapsed diffuse large B-cell lymphoma (DLBCL)

Key Dates

Start date
Apr 30, 2021
Status verified
Jun 2026
Primary completion
Dec 19, 2025
Completion
Dec 19, 2025

Study Design

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

Arms

  • Experimental: Experimental Arm: Pola-R-ICE
    combination of standard chemotherapy with polatuzumab vedotin (Pola-R-ICE) Application
  • Active Comparator: Standard Arm: R-ICE
    conventional treatment with rituximab, ifosfamide, carboplatin and etoposide (R-ICE)

Primary Outcome Measure

Assessment of the event-free survival of patients with DLBCL at first progression and the occurrence of any of the following events: [ Time Frame: Day of randomization until end of follow up (12 weeks treatment and at least 21 months follow up) ]

Related Studies