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)
This important study is looking at new ways to treat Diffuse Large B-cell Lymphoma (DLBCL), a type of blood cancer, when it returns or hasn't responded fully to the first round of treatment. Researchers want to see if adding a drug called polatuzumab vedotin to a standard chemotherapy treatment (R-ICE) works better than R-ICE alone. The study is comparing these two options to find the most effective approach. Patients will be randomly assigned to receive one of the treatments. This is a Phase 3 study, meaning it's a key step in seeing if the new combination can become a standard treatment for patients in the future.
At a glance
What is this study about?
This study is designed for individuals diagnosed with Diffuse Large B-cell Lymphoma (DLBCL) – a type of cancer that affects special white blood cells called B-cells. Specifically, it's for those whose cancer has either come back after initial treatment (this is called 'relapsed') or hasn't fully responded to their first treatment (known as 'refractory'). It's common for medical teams to look for different ways to treat these situations, and this study aims to find a more effective option.
The study compares two treatment approaches. One is a commonly used chemotherapy called R-ICE, which is a combination of several medicines: rituximab (also known as Mabthera), ifosfamide, carboplatin, and etoposide. The other approach takes this same R-ICE chemotherapy and adds a new drug called polatuzumab vedotin. Researchers want to find out if adding polatuzumab vedotin to R-ICE is a better treatment choice than R-ICE on its own for people in this situation.
By carefully comparing these two treatments, the study hopes to identify the best way forward for patients with relapsed or refractory DLBCL. This type of research is crucial because it helps doctors understand which treatments are most effective, ultimately improving care and outcomes for patients.
Key takeaways
- This study evaluates a new combination treatment for specific types of non-Hodgkin lymphoma.
- It aims to find out if adding polatuzumab vedotin to standard R-ICE chemotherapy is more effective.
- The study is for patients whose DLBCL has returned or not fully responded to initial treatment.
- You would receive either the standard R-ICE or the Pola-R-ICE combination.
- Participation involves about 3 months of treatment and over 21 months of health follow-ups.
- Your doctor can help determine if this study is suitable for your situation.
Who may be eligible?
To be considered for this study, you would need to be an adult, generally 18 years or older across most participating countries, though in the UK, individuals aged 16 and over may be eligible. You should be able to understand and follow the study instructions, and crucially, you must have a diagnosis of specific types of Diffuse Large B-cell Lymphoma that have either come back or not fully responded to your first main treatment.
Specifically, your lymphoma would be considered 'refractory' if it didn't completely go away after your first treatment, or if it didn't disappear and then worsened while still on, or shortly after, treatment. If your lymphoma did go away completely after your first treatment but then returned later, it would be considered 'relapsed'.
There are also some health requirements, commonly assessed by your medical team, to ensure you are well enough to participate in a study like this. If you fit this general description, your doctor can check the full details to see if you might be a good fit.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years or older (or 16+ in the UK)?
- Have you been diagnosed with Diffuse Large B-cell Lymphoma (DLBCL) that has returned or not fully responded to previous treatments?
- Do you feel able to understand and follow study instructions?
- Are you willing to have regular appointments and follow-up checks?
- Do you have a specific type of B-cell lymphoma that fits the study criteria?
What does participation involve?
If you join this study, the total time you would be actively involved is about 3 months for the treatment phase, followed by at least 21 months where your health will be regularly checked up on. Before starting, there's a screening visit to make sure the study is right for you, and you'll need to sign a consent form. While you're on the study, you'll have three cycles of treatment, which involve getting the study medications. You'll then have a final visit at the end of your treatment.
After treatment, you'll have follow-up visits to monitor your health and how well the treatment worked over time. These checks will continue for at least 21 months. During the study, you'll be randomly assigned to one of two groups: either the standard R-ICE chemotherapy or the R-ICE chemotherapy with the addition of polatuzumab vedotin. Your participation in the study continues until the research team has gathered all necessary information, which involves tracking the long-term health of all participants.
Potential risks and benefits
Locations (64)
- UK Graz Universitätsklinik für Innere Medizin Klinische Abteilung für HämatologieVerified postcodeGraz, Austria
- LKH Hochsteiermark Standort Leoben Abteilung für Innere Medizin Department für Hämato-OnkologieVerified postcodeLeoben, Austria
- Ordensklinikum Linz GmbH- Elisabethinen: I. Interne Abteilung Hämato-OnkologieVerified postcodeLinz, Austria
- Kepler Universitätsklinikum Med Campus III, Univ.-Klinik für Hämatologie und Internistische OnkologieVerified postcodeLinz, Austria
- Landeskrankenhaus SalzburgVerified postcodeSalzburg, Austria
- AKH Meduni Wien Universitätsklinik für Innere Medizin I:Verified postcodeVienna, Austria
- Hanusch KrankenhausVerified postcodeVienna, Austria
- Klinikum Wels-Grieskirchen Abteilung für Innere Medizin IVVerified postcodeWels, Austria
- Universitätsklinikum RWTH-AachenVerified postcodeAachen, Germany
- HELIOS Klinik Berlin-Buch, Klinik für Hämatologie und StammzelltransplantationVerified postcodeBerlin, Germany
- Städtisches Klinikum BraunschweigVerified postcodeBraunschweig, Germany
- DIAKO Ev.Diakonie-Krankenhaus gemeinnützige GmbHVerified postcodeBremen, Germany
Common questions
What is DLBCL?
DLBCL stands for Diffuse Large B-cell Lymphoma, which is a type of cancer that affects specific white blood cells in your body.
What does 'relapsed' or 'refractory' mean for my cancer?
Relapsed means your cancer came back after it had previously gone away. Refractory means your cancer didn't fully respond or worsened during your first treatment.
What is the new drug in this study?
The new drug being studied is called Polatuzumab Vedotin, and it's being tested alongside a standard chemotherapy called R-ICE.
Will I know which treatment I'm getting?
Yes, this is an 'open-label' study, so both you and your doctors will know whether you are receiving the standard R-ICE or Pola-R-ICE.
How long will my involvement in the study last?
The active treatment part of the study lasts about 3 months, followed by at least 21 months of follow-up visits to check on your health.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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