MedTrace Logo

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)

NCT04833114 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 306

Last updated 2025-09-30

No results posted yet for this study

Summary

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)

Conditions

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

Interventions

DRUG

Polatuzumab Vedotin

Polatuzumab vedotin 1.8 mg/kg will be administered intravenously on Day 1 of each 21-day cycle for up to 3 cycles.

DRUG

Mabthera

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.

DRUG

Ifosfamide

Ifosfamide 5000 mg/m² will be administered i.v. over a 24 hr period starting on cycle Day 2.

DRUG

Carboplatin

Carboplatin AUC 5 max 800 mg will be administered i.v. on cycle Day 2.

DRUG

Etoposide

Etoposide 100 mg/m² will be administered i.v. on cycle Days 1, 2 and 3.

Sponsors & Collaborators

Principal Investigators

  • Bertram Glaß, Prof. · HELIOS Klinik Berlin-Buch, Klinik für Hämatologie und Stammzelltransplantation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-30
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Austria
  • Germany
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04833114 on ClinicalTrials.gov