Active not recruitingPHASE3INTERVENTIONAL

Study to Evaluate Loncastuximab Tesirine With Rituximab Versus Immunochemotherapy in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Doctors are running a study for adults aged 18 and over who have a specific type of blood cancer called diffuse large B-cell lymphoma (DLBCL). This is for people whose cancer has either returned after shrinking with previous treatment (relapsed) or has not responded to treatment at all (refractory). The study is comparing a new treatment combination, loncastuximab tesirine with rituximab, against the usual chemotherapy treatments. The main goal is to find out if the new combination is more effective at treating the cancer. It's a 'Phase 3' study, meaning it's a key step in seeing if the new treatment is better than current options.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

ADC Therapeutics S.A.

Enrolment target

440

Start

16 Sep 2020

Estimated completion

30 Jun 2028

Relapsed Diffuse Large B-Cell Lymphoma Refractory Diffuse Large B-Cell Lymphoma

What is this study about?

This study is designed for adults living with a specific kind of blood cancer called diffuse large B-cell lymphoma (DLBCL). This is a cancer of the white blood cells, which are part of your body's immune system. Specifically, the study is for patients whose DLBCL has either come back after previously being treated successfully (this is called 'relapsed') or hasn't responded to previous treatments at all (this is called 'refractory'). It's really hard when cancer comes back or doesn't respond, so doctors are always looking for new and better ways to help.

The main aim of this study is to compare a new treatment combination with the standard treatments currently used. The new combination involves a drug called loncastuximab tesirine, given alongside rituximab. Researchers want to see if this new approach is more effective at shrinking the cancer or stopping it from growing compared to the usual chemotherapy treatments you might receive. Finding more effective treatments could offer a new option for people facing difficult-to-treat DLBCL.

This is a 'Phase 3' study, which means it's a large, important step in testing new medicines. In this phase, researchers are confident enough in the new treatment to compare it directly with existing standard care on a larger group of patients. It's about finding out if the new treatment offers clear benefits over what's currently available, with a reasonable level of safety.

Key takeaways

This study is for adults with relapsed or refractory DLBCL.
It compares a new drug combination against standard chemotherapy.
The aim is to find a more effective treatment option.
Participants will be closely monitored by a medical team.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older, and have received a clear diagnosis of diffuse large B-cell lymphoma (DLBCL). This includes if your DLBCL started from another slower-growing lymphoma.

Your cancer must have either come back after previous treatment, or it didn't respond to previous treatments. It's important that your doctor doesn't think a stem cell transplant is the best option for you right now, perhaps due to your general health, age, or other medical problems. You'll also need to have areas of your cancer that can be measured by scans. Your body's organs, like your kidneys and liver, need to be working well enough to take part.

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 old or older?
Have you been diagnosed with diffuse large B-cell lymphoma (DLBCL)?
Has your DLBCL either come back or not responded to previous treatments?
Has your doctor said you're not suitable for a stem cell transplant right now?
Are your general health and organ functions considered good enough to take part?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be assigned to receive either the new drug combination (loncastuximab tesirine with rituximab) or one of the standard chemotherapy treatments. This decision is made randomly, like flipping a coin. You would have regular visits to the clinic for treatments, which are usually given through a drip (intravenously).

During your time in the study, you'll have various check-ups, blood tests, and scans (like PET-CT or CT scans) to monitor your health and how the treatment is working. Doctors will also ask you questions about how you're feeling and any side effects you might be having. After your treatment period, there will be follow-up visits or calls to keep track of your health long-term. The total length of your active treatment and follow-up in the study would be explained in detail by your study team.

Potential risks and benefits

Participating in this study might offer the potential benefit of receiving a new treatment that could be more effective for your type of lymphoma. However, like all medical treatments, there are potential risks and side effects associated with both the new drugs and the standard treatments. The study team will carefully monitor you for any side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care. Your doctors will discuss all potential benefits and risks with you in detail so you can make an informed decision.

Locations (144)

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

University of California San Diego Moores Cancer Center
Verified postcode
La Jolla, United States
Redlands Community Hospital
Verified postcode
Redlands, United States
The Oncology Institute of Hope and Innovation
Verified postcode
Whittier, United States
Baptist MD Anderson Cancer Center
Verified postcode
Jacksonville, United States
UnityPoint Health - Iowa Oncology Research Association (IORA)
Verified postcode
Des Moines, United States
Norton Cancer Institute
Verified postcode
Louisville, United States
Comprehensive Cancer Centers of Nevada - Henderson
Verified postcode
Las Vegas, United States
Kaiser Permanente Interstate Medical Office Central
Verified postcode
Portland, United States
Hollings Cancer Center
Verified postcode
Charleston, United States
Virginia Cancer Specialists
Verified postcode
Gainesville, United States
Medical College of Wisconsin Cancer Center Clinical Trials Office
Verified postcode
Milwaukee, United States
Clinica Adventista Belgrano
Unverified
Belgrano, Argentina

Common questions

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

DLBCL is a fast-growing type of cancer that starts in white blood cells called lymphocytes, which are part of your immune system.

What does 'relapsed or refractory' mean?

Relapsed means your cancer came back after treatment, and refractory means it didn't respond to previous treatment at all.

Will I definitely get the new drug?

No, you might receive the new drug combination or a standard chemotherapy. Which one you get is decided by chance, like a lottery.

What is a 'Phase 3' study?

It's a big study where doctors compare a new treatment with existing standard treatments to see if the new one is better and safer.

Can I stop being part of the study once I start?

Yes, you can choose to leave the study at any time, and your decision will not affect your future medical care.