Polatuzumab Vedotin Plus Rituximab, Ifosfamide, Carboplatin and Etoposide (Pola-R-ICE) Versus R-I… (NCT04833114) | Clinical Trial Compass
CompletedPhase 3
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)
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)
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. The informed consent form must be signed before any study specific tests or procedures are done
. Adult male and female patients ≥18 years (≥16 years in the UK\*) at the time of inclusion in the study (\* In the UK an "adult" means a person who has attained the age of 16 years, according to The Medicines for Human Use (Clinical Trials) Regulations 2004, Part 1 Point 2.)
. Ability to understand and follow study-related instructions
. Risk group: All patients with one of the following histologically defined entities: Histological diagnosis of primary refractory or relapsed aggressive B-cell non-Hodgkin lymphoma (B-NHL), confirmed by a biopsy of involved nodal or extranodal site. Patients with any of the following histologies can be included:
. Performance Status ECOG 0-2 at time of randomization or ECOG 3 at screening if this is DLBCL-related and has improved to ECOG 2 or less with a 7-day steroid treatment during the screening Phase (e.g. 1 mg/kg prednisone).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compared adding polatuzumab vedotin to the standard R-ICE chemotherapy regimen for relapsed or refractory DLBCL — based on what the results showed about event-free survival, does the data suggest that adding polatuzumab vedotin actually improved outcomes, and would that combination be worth considering in my situation?
2Since this was a Phase 3 trial that has now completed recruitment, has the full data been published or presented, and can you walk me through what the findings mean for someone in my position with relapsed or refractory DLBCL?
3R-ICE already involves three intensive chemotherapy drugs, and this trial added a fourth agent, polatuzumab vedotin — based on the trial's safety findings, what additional side effects or risks came with the combination compared to R-ICE alone?
4The trial focused on patients at first progression of DLBCL, which sounds like it matches my situation — is this the right point in my treatment to be considering a regimen like this, or would standard R-ICE or another approach be a more appropriate first step?
5Since the goal of second-line treatment is often to get to a stem cell transplant, did the trial report on how many patients in each group were able to go on to transplant after this regimen, and does that factor into your recommendation for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assessment of the event-free survival of patients with DLBCL at first progression and the occurrence of any of the following events:
Timeframe: Day of randomization until end of follow up (12 weeks treatment and at least 21 months follow up)
. Information on all 5 International Prognostic Index (IPI) factors
. Staging (PET-CT based-staging according to Lugano criteria 2014). Patients must have PET-positive lesions.
. Subjects must have received adequate first line therapy including at a minimum: i) anti-CD20 monoclonal antibody unless Investigator determines that tumor is CD20 negative, and ii) an anthracycline containing chemotherapy Regimen