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A lymphoma clinical study - IND245

A study of two drugs in patients planning to receive CAR-T therapy as standard of care for mantle cell lymphoma
Disease Site
Investigational New Drug Program
Trial Code
IND.245 ǀ NCT07341191
Trial Status

What is the purpose of this study?

The purpose of this study is to help researchers to better understand the effect of giving two oral medications in patients with mantle cell lymphoma (MCL) who are planning to receive standard of care CAR-T cell therapy.

Why is this study important?

This study will help researchers to better understand if these two medications make things better or worse than the usual approach alone (CAR-T cell therapy).

Who can participate in this study?

This trial is for:

  • People diagnosed with mantle cell lymphoma
  • People eligible and planning to receive treatment with approved CAR-T Cell therapy
  • People who have received a BTK inhibitor and chemoimmunotherapy
  • People who can swallow oral drugs and do not have any gastrointestinal problems that may affect absorption
  • People with other types of cancer requiring anticancer treatment(s)

This trial is not for:

  • People with recent or uncontrolled significant heart conditions and serious illnesses
  • People who have active, untreated infections of Hepatitis C, Hepatitis B or other serious infections
  • People taking growth factors (medication to help make red blood cells) such erythropoietin

You will find complete details of who this trial is for by visiting https://www.clinicaltrials.gov/study/NCT07341191

What are the risks?
  • If you choose to take part in this study, there is a risk that the addition of the drug combination may not be as good as the usual approach alone (CAR-T cell therapy) at shrinking or stabilizing your cancer.
  • There is also a risk that you could have side effects from the drugs.
  • Some of the most common side effects that the study doctors know about are: 
    • lowering of blood cell counts (white cells and platelets), 
    • a decrease in number of red blood cells (anemia). 
    • Tiredness 
    • Nausea/ vomiting, 
    • Dizziness 
    • Joint pain
  • You will find details of all side effects in the informed consent document.
What can I expect?
  • If you choose to take part in this study, you will receive the study drugs before and after your planned standard of care CAR-T cell therapy. You will also be asked to complete diaries to record the number of pills you take.

How can I find out more or join the study?

Talk to your cancer doctor if you are considering joining this study. You can share summaries like this with them and ask if they think joining the study may be a good option for you.

Before you join this study, you will be asked to review an Informed Consent document which will tell you more about why the research is being done and your role as a participant. You will have an opportunity to discuss anything that is not clear and ask any questions you have.

Joining this study is entirely up to you and you can decide to leave at any time without giving a reason. Your decision to join or leave the study will not affect your standard medical care.

The IND.245 study is currently enrolling patients at cancer centres in Canada. For a full list of participating cancer centres please visit https://www.clinicaltrials.gov/study/NCT07341191

Use this trial information for your conversation with your health care team

Participating centres

Information coming soon.