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The University of Southampton
Southampton Clinical Trials Unit

Pola-R-ICE

Title

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).

Description

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).

The study will investigate the addition of polatuzumab vedotin (Pola) to rituximab, ifosfamide, carboplatin and etoposide (RICE), a standard chemotherapy treatment regimen versus treatment with RICE alone, in patients with primary refractory or relapsed diffuse large B-cell lymphoma (DLBCL).

Over 50% of DLBCL patients will not achieve a remission with standard second line salvage therapies. Therefore, there is an unmet medical need to optimise second line therapy in progressive and relapsed aggressive B cell non-Hodgkin lymphoma.

Polatuzumab vedotin is an antibody drug conjugate, targeted to the CD79b antibody expressed on a majority if B cell derived malignancies. In initial studies, polatuzumab vedotin has shown very promising response rates. The RICE regimen will be used as the comparator/standard arm. RICE is regarded as less toxic than some other regimens but still with comparable response rates.

This is the first study to assess the Pola-RICE combination and as such, as well as efficacy objectives, particular attention will be paid to safety objectives.

Objectives

Primary:

  • The primary objective of this study is to investigate the following question in patients with relapsed or primary refractory DLBCL: Does salvage therapy with Pola-R-ICE improve event-free survival (EFS) compared to R-ICE alone?

Secondary:

The secondary efficacy objectives of the study are to collect data in order to evaluate whether the addition of polatuzumab vedotin to standard therapy R-ICE:

  • Enhances the rate of metabolic complete response (CR) at the end of study treatment.
  • Enhances the partial response (PR) rate and overall response rate (ORR) and decreases the progression rate and relapse rate.
  • Enhances the duration of response, progression-free survival (PFS) and overall survival (OS).
  • Impacts the mobilization of autologous CD34+ stem cells.
  • Enhances the rate of patients proceeding to transplantation.
  • Impacts the non-relapse mortality.

Further secondary objectives of the study regarding safety, protocol adherence, quality of life (QoL) and biology are to collect data in order to evaluate; adverse and serious adverse events, incidence and duration of neutropenia and thrombocytopenia Grade 4 CTC, rate of treatment-related deaths, number of second malignancies, cumulative and relative doses, and QoL, as well as to provide samples for translational research.

Trial Design

Trial schema flow chart for Pola-R-ICE
Click to enlarge image

This is a multicentre, international, open-label, randomised phase III trial.

The study will have two treatment arms; Pola-RICE vs RICE and patients will be randomised on a 1:1 basis.

The study will aim to recruit 334 patients across 4 countries; Germany, Austria, Spain and the UK. 75 patients will be recruited from the UK.

Following informed consent, all patients will receive 3 cycles of chemotherapy; half the patients will receive Pola-RICE and half the patients will receive RICE.  Patients will then be followed up (3 monthly visits) for at least a further 21 months. Therefore, each patient will be involved in the study for a minimum of 24 months.

Trial Status

Open to recruitment

Population

Patients aged 16 years and over with relapsed or primary refractory DLBCL.

CRUK and MIHR logos

The study is an investigator-initiated trial with financial support by F. Hoffmann-La Roche Ltd. The trial is endorsed by Cancer Research UK (award ref CRCET\100004) and NIHR adopted.

Senior Trial Manager:

Joshua Caddy

Trial Manager:

Tracey Mason

Contact Information for trial queries:

Email: [email protected]

Phone: 023 8120 5154

SAE Reporting:

PV is being performed by ZKS Leipzig

Email: [email protected]

Phone: +49 341 97 16129

Fax: +49 341 97 16278

Study Documents:

Pola-R-ICE – Study Contacts and Information v1 21 Mar 2022

Pola-R-ICE – UK Specific Protocol Appendix v2 01 Mar 2022

Pola-R-ICE – Protocol v4, 28 Aug 2022

Pola-R-ICE – Financial Disclosure v3 19 Jan 2021

Pola-R-ICE – Patient Identification Log v1 19 Jan 2021

Pola-R-ICE –Site Delegation Log v2.1 18 Jun 2021

Pola-R-ICE –Site Training Log v2.1 18 Jun 2021

Patient Documents

Pola-R-ICE –GP Letter v2 20 Dec 2021

Pola-R-ICE –Informed Consent Form v2 20 Dec 2021

Pola-R-ICE –Optional translational samples consent form v2 20 Dec 2021

Pola-R-ICE –Optional Translational samples Patient Information Sheet v2 20 Dec 2021

Pola-R-ICE –Patient Information Sheet v2 20 Dec 2021

Pola-R-ICE –Pregnancy follow up consent form v2 20 Dec 2021

Pola-R-ICE –Pregnancy Information Sheet v2 20 Dec 2021

EQ-5D-5L Englishv1.2

FACT-Lym English v4

QLQ-C30 English V3

Pharmacy Documents

Pola-R-ICE –Pharmacy Manual v3 18 Oct 2022

Pola-R-ICE –IMP Shipping Request v5

Pola-R-ICE –Patient DAF Carboplatin v5 24 May 2022 UK

Pola-R-ICE –Patient DAF Etoposide v5 24 May 2022 UK

Pola-R-ICE –Patient DAF Ifosfamide v5 24 May 2022 UK

Pola-R-ICE –Patient DAF Polatuzumab v5 24 May 2022 UK

Pola-R-ICE – Patient DAF Rituximab v5 24 May 2022 UK

Pola-R-ICE - IB Polivy v14, Oct 2022

Pola-R-ICE - IB Rituximab v28 Jun 2022

Laboratory Documents

Pola-R-ICE –HMDS Sample Shipment Form v2 20 Oct 2022

Pola-R-ICE –HMDS Sample Dispatch Log v1 05 Oct 2022

Pola-R-ICE –Laboratory Manual v1 15 Sep 2021

SAE Documents

Pola-R-ICE –SAE report form v2 15 Nov 2022

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