Active not recruitingPHASE3INTERVENTIONAL

Tafasitamab + Lenalidomide + R-CHOP Versus R-CHOP in Newly Diagnosed High-intermediate and High Risk DLBCL Patients

This important study is testing a new way to treat Diffuse Large B-cell Lymphoma (DLBCL), a type of blood cancer. Doctors want to find out if adding two drugs, tafasitamab and lenalidomide, to the usual chemotherapy (called R-CHOP) is more effective and safe for people who have been recently diagnosed with higher-risk DLBCL. Participants in this study will either receive the new combination plus R-CHOP or R-CHOP on its own, with placebos for the new drugs to ensure a fair comparison. This is a "Phase 3" study, meaning it's a large trial to see if the new treatment should become a standard option. It aims to improve outcomes for patients with this specific type of cancer.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Incyte Corporation

Enrolment target

899

Start

11 May 2021

Estimated completion

01 Nov 2027

Diffuse Large B-cell Lymphoma

What is this study about?

This study is for people who have recently been diagnosed with a type of blood cancer called Diffuse Large B-cell Lymphoma (DLBCL), specifically those with a higher risk form of the disease. DLBCL is a serious condition, and while standard treatments like R-CHOP chemotherapy can be effective, doctors are always looking for ways to make treatments even better and safer.

Here, they are investigating whether adding two new drugs – tafasitamab and lenalidomide – to the standard R-CHOP chemotherapy can improve patient outcomes. Tafasitamab is a type of targeted therapy designed to recognise and attack cancer cells, while lenalidomide also helps to fight cancer and supports the immune system. The study wants to compare this new combination directly with R-CHOP on its own.

This is a "Phase 3" study, which means it’s a big, carefully designed trial. Participants will be randomly assigned to receive either the new drug combination plus R-CHOP, or R-CHOP with inactive 'dummy' drugs (placebos) that look just like tafasitamab and lenalidomide. Neither you nor your doctor will know which treatment you are receiving, which helps make the results as accurate as possible. The aim is to see if this new approach can lead to better results for patients with newly diagnosed, higher-risk DLBCL.

Key takeaways

This study is for newly diagnosed, higher-risk DLBCL.
It compares standard R-CHOP with R-CHOP plus two new drugs (tafasitamab and lenalidomide).
It's a large, important 'Phase 3' study.
Participants will be randomly assigned to a treatment group.
The study aims to find better treatments for DLBCL.
You will be closely monitored throughout your participation.

Who may be eligible?

This study is looking for adults aged between 18 and 80 years old who have recently been diagnosed with Diffuse Large B-cell Lymphoma (DLBCL). Your doctors need to have confirmed your specific type of DLBCL through a biopsy (tissue sample). It's important that your cancer has not been treated with any other therapies yet.

You should also be generally well enough to receive strong chemotherapy, and your heart and other important organs need to be working adequately. The time between your DLBCL diagnosis and starting the study treatment generally needs to be within 28 days. The study is specifically for patients whose DLBCL is considered "high-intermediate" or "high risk" based on certain medical scores.

There are also some more specific medical details that your doctor will check. For example, if your doctors feel you need a much more aggressive type of chemotherapy than R-CHOP, this study might not be suitable for you.

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 between 18 and 80 years old?
Have you been newly diagnosed with Diffuse Large B-cell Lymphoma (DLBCL)?
Have you not received any prior treatment for your DLBCL?
Are you generally well enough to receive strong chemotherapy?
Do you have a higher-risk type of DLBCL (your doctor can confirm this)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be randomly assigned to one of two groups: either you'll receive the new drugs (tafasitamab and lenalidomide) along with your regular R-CHOP chemotherapy, or you'll receive R-CHOP chemotherapy along with placebos (dummy drugs) for tafasitamab and lenalidomide. Neither you nor your study doctor will know which group you are in. You will have regular appointments for your treatments and check-ups, which will include blood tests, scans, and other medical assessments to monitor your health and how the treatment is working. It's really important that your medical team closely monitors you throughout the study. The total duration of your participation, including follow-up after treatment stops, will be explained by your study team.

Potential risks and benefits

Participating in a clinical trial may offer benefits like receiving a new treatment that isn’t widely available, and having very close medical monitoring from a team of experts. However, there are also potential risks, as new treatments can have side effects that aren't fully known, or they may not work as expected. Your doctors will discuss all known potential side effects of the drugs used. You are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (307)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

MorphoSys Research Site
Verified postcode
Daphne, United States
MorphoSys Research Site
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Anaheim, United States
MorphoSys Research Site
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Clovis, United States
MorphoSys Research Site
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Fullerton, United States
MorphoSys Research Site
Verified postcode
Harbor City, United States
MorphoSys Research Site
Verified postcode
Los Angeles, United States
MorphoSys Research Site
Verified postcode
San Diego, United States
MorphoSys Research Site
Verified postcode
Whittier, United States
MorphoSys Research Site
Verified postcode
Aurora, United States
MorphoSys Research Site
Verified postcode
Jacksonville, United States
MorphoSys Research Site
Verified postcode
Honolulu, United States
MorphoSys Research Site
Verified postcode
Wichita, United States

Common questions

What is Diffuse Large B-cell Lymphoma (DLBCL)?

DLBCL is a common type of fast-growing blood cancer that affects white blood cells called B-cells. It can start almost anywhere in the body.

What is R-CHOP chemotherapy?

R-CHOP is a standard combination of drugs used to treat DLBCL. It includes Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone.

What are tafasitamab and lenalidomide?

Tafasitamab is a newer drug designed to target specific markers on cancer cells. Lenalidomide is another drug that helps fight cancer and improve the immune system's response.

What does 'double-blind, placebo-controlled' mean?

It means neither you nor your doctor will know if you're getting the new active drugs or inactive dummy drugs (placebos). This helps ensure the study results are fair and accurate.

Why is this study important?

This study aims to find out if adding new drugs to standard chemotherapy can improve the chances of successful treatment for people with higher-risk DLBCL.