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)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508259-38-00

Acronym

MO40599/GLA 2017-R2

Enrollment

302

Registered

2024-02-07

Start date

2021-04-29

Completion date

2025-12-19

Last updated

2025-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult patients with relapsed or primary refractory DLBCL

Brief summary

The primary endpoint is EFS of patients with DLBCL at first progression or relapse.

Detailed description

Secondary endpoints for efficacy are rate of metabolic CR after end of study treatment, PR rate, ORR, duration of response, progression rate, relapse rate, PFS, OS, number of CD34+ cells, mobilization failure rate, rate of patients proceeding to transplantation, and non-relapse mortality, Secondary safety endpoints: Adverse events (AE), Serious adverse events (SAE), Incidence and duration of neutropenia and thrombocytopenia Grade 4 CTC, Rate of treatment-related deaths, Second malignancies, Secondary endpoints for protocol adherence: Number of chemotherapy cycles, Duration of chemotherapy cycles, Cumulative dose and relative dose of ifosfamide, carboplatin and etoposide, Cumulative dose and relative dose of rituximab, Cumulative dose and relative dose of the polatuzumab vedotin, Secondary endpoints for QoL: Secondary endpoint is evaluation of generic health-related QoL as assessed by different questionnaires

Interventions

DRUGETOPOPHOS® 100 mg

DRUGPulver zur Herstellung einer Infusionslösung

DRUGMabThera 500 mg concentrate for solution for infusion

DRUGCarboplatino Pharmacia 10 mg/ml concentrado para solución para perfusión EFG

DRUGHoloxan

DRUGEtoposid Accord 20 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGCarboplatin onkovis 10 mg/ml Infusionslösung

DRUGHoloxan 2 g - Trockensubstanz zur Injektionsbereitung

DRUGIfosfamide Injection 1g

DRUGEtopósido Sandoz 20 mg/ml concentrado para solución para perfusión EFG

DRUGPolivy 140 mg powder for concentrate for solution for infusion.

DRUGCarboplatin Accord 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGHoloxan 1 g -Trockensubstanz zur Injektionsbereitung

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint is EFS of patients with DLBCL at first progression or relapse.	—

Secondary

Measure	Time frame
Secondary endpoints for efficacy are rate of metabolic CR after end of study treatment, PR rate, ORR, duration of response, progression rate, relapse rate, PFS, OS, number of CD34+ cells, mobilization failure rate, rate of patients proceeding to transplantation, and non-relapse mortality, Secondary safety endpoints: Adverse events (AE), Serious adverse events (SAE), Incidence and duration of neutropenia and thrombocytopenia Grade 4 CTC, Rate of treatment-related deaths, Second malignancies, Secondary endpoints for protocol adherence: Number of chemotherapy cycles, Duration of chemotherapy cycles, Cumulative dose and relative dose of ifosfamide, carboplatin and etoposide, Cumulative dose and relative dose of rituximab, Cumulative dose and relative dose of the polatuzumab vedotin, Secondary endpoints for QoL: Secondary endpoint is evaluation of generic health-related QoL as assessed by different questionnaires	—

Measure

Time frame

—

Countries

Austria, Germany, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026