All studies
Active not recruitingPHASE3INTERVENTIONAL

Study to Evaluate the Safety and Efficacy of Tafasitamab Plus Lenalidomide in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (firmMIND)

This research trial is investigating a new treatment combination for adults in the UK with a specific type of blood cancer called diffuse large B-cell lymphoma (DLBCL). The treatment involves two medicines, tafasitamab and lenalidomide. This study is for people whose DLBCL has come back after earlier treatments (relapsed) or hasn't fully responded to them (refractory). Importantly, it's for those who have tried at least one, but no more than three, previous treatments and are not able to undergo high-dose chemotherapy followed by a stem cell transplant. The main goal is to see how safe and effective this new drug combination is in helping manage the cancer.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Incyte Corporation
Enrolment target
82
Start
23 Dec 2022
Estimated completion
01 Apr 2027

What is this study about?

This study, called firmMIND, is exploring a new treatment approach for a type of cancer that affects white blood cells, called diffuse large B-cell lymphoma (DLBCL). DLBCL is a fast-growing cancer. In this study, doctors are testing a combination of two drugs, tafasitamab and lenalidomide. Tafasitamab is a type of targeted therapy designed to find and attack cancer cells, while lenalidomide is a drug that works by changing how the immune system responds to cancer and by directly affecting cancer cell growth.

The researchers want to see if this combination treatment is safe and if it can help people whose DLBCL has either come back after past treatments or hasn't fully responded to them. It's specifically for those who have already tried a few treatments (between one and three) but aren't suitable for a stem cell transplant, which is another common treatment option for DLBCL.

Understanding how well these drugs work together and their side effects is really important. The hope is that this study will lead to a new, effective treatment option for people with DLBCL who currently have limited choices. This is a Phase 3 study, which means it's a larger study comparing the new treatment to standard care, or in this case, assessing the benefits of the combination for this specific group of patients, building on earlier research.

Key takeaways

  • This study is testing a new drug combination for a type of blood cancer (DLBCL).
  • It's for adults whose cancer has returned or hasn't responded well to previous treatments.
  • It targets patients who are not suitable for a stem cell transplant.
  • The study aims to see how safe and effective tafasitamab plus lenalidomide is.
  • Participation involves regular clinic visits, tests, and monitoring.

Who may be eligible?

To be eligible for this study, you would need to have been diagnosed with diffuse large B-cell lymphoma (DLBCL) or certain related types of lymphoma that have transformed into DLBCL. Your cancer must have returned or continued to progress after your most recent treatment, and you should have tried between one and three previous treatments. It's also important that you are generally well enough to take part, as assessed by your doctor, and that you are not suitable for a stem cell transplant.

There are also some conditions that would mean you couldn't join the study. For example, if you have certain other specific types of lymphoma, or if your DLBCL was found to be 'primary refractory' (meaning it didn't respond at all to the very first treatment) or has certain genetic changes (like 'double- or triple-hit' DLBCL). You also shouldn't have had certain other cancer treatments or major surgery recently, or received live vaccines in the last month. The study also requires you to be willing to avoid getting pregnant or fathering a child during the study.

Quick self-check
  • Have you been diagnosed with DLBCL or a related lymphoma that has transformed into DLBCL?
  • Has your DLBCL returned or not fully responded to 1-3 previous treatments?
  • Are you unable to have a stem cell transplant?
  • Are you generally well enough to participate, as determined by your doctor?
  • Are you willing to avoid pregnancy or fathering children during the study?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will receive the study medications, tafasitamab and lenalidomide. Your health will be carefully monitored throughout. This will involve regular visits to the clinic for check-ups, blood tests, and scans to see how the treatment is working and to monitor for any side effects. You might also be asked to provide tissue samples, like a biopsy of your tumour and bone marrow, both at the start and potentially during the study. The total duration of your participation in the study will depend on how you respond to the treatment and the study plan, but there will be ongoing follow-up to monitor your health. You will also have scheduled follow-up visits after stopping the study medication.

Potential risks and benefits

Like all medical treatments, there are potential benefits and potential risks to consider. The potential benefit of taking part in this study is that you might receive a new treatment combination that could help manage your DLBCL, especially if other treatments haven't worked or aren't an option. However, there's no guarantee the treatment will work for everyone, and you could experience side effects from the medications, which your care team will explain in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (61)

  • Medical University Plovdiv
    Plovdiv, Bulgaria
  • Acibadem Cityclinica Mhat Tokuda
    Sofia, Bulgaria
  • Umhat Alexandrovska Sofia
    Sofia, Bulgaria
  • Umhat Sv. Ivan Rilski Ead
    Sofia, Bulgaria
  • Specialized Hospital For Active Treatment of Oncological Diseases - Sofia District Eood
    Sofia, Bulgaria
  • Clinical Hospital Dubrava
    Zagreb, Croatia
  • Clinical Hospital Merkur
    Zagreb, Croatia
  • University Hospital Centre Zagreb
    Zagreb, Croatia
  • Fakultni Nemocnice Olomouc
    Olomouc, Czechia
  • Vseobecna Fakultni Nemocnice
    Prague, Czechia
  • Aarhus University Hospital
    Aarhus, Denmark
  • Odense University Hospital
    Odense, Denmark

+49 more sites — see the official record for the full list.

Common questions

What is diffuse large B-cell lymphoma (DLBCL)?

DLBCL is a type of fast-growing cancer that affects white blood cells called lymphocytes.

What are tafasitamab and lenalidomide?

These are two different medications. Tafasitamab is a targeted drug that helps your immune system fight cancer, and lenalidomide affects your immune system and cancer cells.

Who is this study for?

It's for adults with DLBCL whose cancer has returned or not responded to previous treatments, and who can't have a stem cell transplant.

What does 'relapsed or refractory' mean?

Relapsed means the cancer has come back after treatment. Refractory means the cancer did not respond to treatment or continued to grow.

Can I still have a stem cell transplant if I join this study?

No, this study is specifically for people with DLBCL who are not able to have a high-dose chemotherapy and stem cell transplant.

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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