All studies
RecruitingPHASE1INTERVENTIONAL

A Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination With Other Anti-cancer Agents in Participants With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7)

This research study, called LOTIS-7, is looking into new ways to treat a type of blood cancer called B-cell non-Hodgkin lymphoma. This is for people whose cancer has either returned after treatment (relapsed) or has not improved with previous treatments (refractory). The study is testing a drug called Loncastuximab Tesirine in combination with other anti-cancer medicines. Its main goals are to find out if these combinations are safe, what the right dose should be, and how effective they are in fighting the cancer. The study involves different stages to slowly increase the doses and then check the effects on more people.

At a glance

Status
Recruiting
Phase
PHASE1
Sponsor
ADC Therapeutics S.A.
Enrolment target
200
Start
17 Jun 2022
Estimated completion
29 Oct 2027

What is this study about?

This study is designed for individuals in the UK who have B-cell non-Hodgkin lymphoma. This is a type of cancer that starts in white blood cells called lymphocytes. The study is specifically for people whose lymphoma has either come back after treatment (this is called relapsed) or has not responded to previous treatments (this is called refractory). Researchers are testing a medicine called Loncastuximab Tesirine to see how it works when given alongside other anti-cancer drugs. This medicine has already been approved for certain types of B-cell lymphoma in some situations, but this study explores new ways to use it.

The main purpose of this study is to make sure these new drug combinations are safe for patients and to identify the best, most effective dose. It's a 'Phase 1' study, which means it's one of the first times these specific combinations are being tested in people. This phase is crucial for understanding how the body reacts to the treatments and if there are any side effects. Doctors will carefully monitor participants to ensure their safety throughout the study.

The study is divided into two main parts. In the first part, different doses of the drug combinations will be tested in small groups of people to find a safe and suitable dose. In the second part, more people will receive the dose that was found to be safe and effective in the first part. This will help researchers gather more information on how well the treatments work and continue to monitor for any side effects. The overall aim is to find better treatment options for people living with B-cell non-Hodgkin lymphoma.

Key takeaways

  • This study is for B-cell non-Hodgkin lymphoma that has returned or not responded to prior treatment.
  • It tests new combinations of drugs, including Loncastuximab Tesirine.
  • The main goals are to find safe doses and see how well treatments work.
  • It's a Phase 1 study, focusing on safety and finding the best dose.
  • The study aims to improve future treatment options for this cancer.

Who may be eligible?

To join this study, participants must be at least 18 years old. You would need to have B-cell non-Hodgkin lymphoma that has either come back after previous treatments or has not responded to at least two previous types of treatment. For certain parts of the study, you might only need to have had one previous treatment.

Your doctor will need to confirm that your cancer can be measured. You also need to be well enough to take part, with decent organ function, and generally be expected to live for at least another 24 weeks. The research team will also need a small piece of your tumour tissue that has been preserved.

Both men and women can participate. If you are a woman who could become pregnant, or a man with a female partner who could become pregnant, you will need to agree to use effective contraception during the study and for some time after the last dose of treatment. This is to prevent pregnancy and ensure the safety of any potential offspring.

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.

  1. Are you 18 years or older?
  2. Do you have B-cell non-Hodgkin lymphoma that has come back or hasn't responded to at least two previous treatments (or one for some parts)?
  3. Is your cancer measurable by current methods?
  4. Are you generally well enough to participate?
  5. Are you able to use contraception if needed, or avoid pregnancy?
Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will receive a combination of medicines being tested. The specific drugs and how often you receive them will depend on which group you are in. You will have regular visits to the hospital or clinic for blood tests, physical examinations, and other checks to monitor your health and how the treatment is working. Doctors will closely watch for any side effects and adjust your care as needed.

The study involves two main parts: a 'dose-finding' part where different doses are tried, and an 'expansion' part where the best dose is given to more people. The total duration of your participation will vary, but you will be monitored throughout your treatment and likely for some time afterwards. The study team will explain all the details of your specific treatment plan and visit schedule before you agree to take part.

Potential risks and benefits

While joining a clinical study can offer the chance to try new treatments that are not yet widely available, there's no guarantee that the treatment will help your specific condition. There is a possibility that the study medications may not work for you, or they could cause side effects. These side effects can range from mild to serious, and the study doctors will explain all known potential side effects to you. Your safety is a top priority, and you will be closely monitored. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (42)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • University of California San Francisco - Fresno Center for Medical Education and Research
    Verified postcode
    Clovis, United States· Recruiting
  • Scripps Health - Prebys Cancer Center
    Verified postcode
    San Diego, United States· Recruiting
  • Sylvester Comprehensive Cancer Center
    Verified postcode
    Miami, United States· Recruiting
  • Miami Cancer Institute
    Verified postcode
    Miami, United States· Recruiting
  • Memorial Cancer Institute - Memorial Hospital West
    Verified postcode
    Pembroke Pines, United States· Recruiting
  • Winship Cancer Institute of Emory University
    Verified postcode
    Atlanta, United States· Recruiting
  • The Blood and Marrow Transplant Group of Georgia
    Verified postcode
    Atlanta, United States· Recruiting
  • Mission Cancer + Blood - Mission Cancer Foundation
    Verified postcode
    Des Moines, United States· Recruiting
  • Beth Israel Deaconess Medical Center
    Verified postcode
    Boston, United States· Recruiting
  • Dana-Farber Cancer Institute
    Verified postcode
    Boston, United States· Recruiting
  • University of Minnesota
    Verified postcode
    Minneapolis, United States· Recruiting
  • Columbia University Irving Medical Center
    Verified postcode
    New York, United States· Recruiting

Common questions

What is B-cell Non-Hodgkin Lymphoma?

It's a type of cancer that starts in certain white blood cells (B-cells) in the body's immune system.

What does 'relapsed or refractory' mean?

Relapsed means the cancer has come back after treatment. Refractory means the cancer hasn't responded to previous treatments.

What is a 'Phase 1' study?

This is one of the first steps in testing a new treatment in people, focusing mainly on safety and finding the right dose.

Will I definitely get the new medication?

Yes, all participants in this study will receive the active study medications in combination, not a placebo.

Can I stop participating in the study if I want to?

Yes, you have the right to leave the study at any time, and this will not affect your future medical care.

How to find out more

Contact ADC Therapeutics

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Study to Evaluate the Safety and Anti-cancer Activity of L…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.