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A primary central nervous system lymphoma clinical trial - IND244

A study of a new drug in addition to the usual treatment for primary central nervous system lymphoma
Disease Site
Hematologic Clinical Trials
Trial Code
IND244 ǀ NCT05998642
Trial Status

What is the purpose of this study?

The purpose of this study is to find out if the addition of a new oral drug to the usual treatment will lower the chance of your primary central nervous system lymphoma (PCNSL) growing or spreading.

 

Why is this study important?

In some other types of lymphoma and leukemia, this new drug works very well and is usual care, helping people live longer. It has been studied in a limited number of people with PCNSL and seems promising, but it is not known if when added to your usual treatment, it will work better than the usual treatment alone. 

 

Who can participate in this study?

 

This trial is for people: 

  • diagnosed with primary CNS lymphoma
  • where treatment with intensive chemotherapy and stem cell transplantation is not an option (either due to older age or having other medical issues preventing this type of treatment)
  • who have not had any treatment other than steroids for their PCNSL

  • who can swallow oral drugs and do not have any gastrointestinal problems that may affect absorption

     

This trial is not for people: 

  • with non-Hodgkin lymphoma in other areas of their body

  • who are being currently treated for another cancer

  • with recent or uncontrolled significant heart conditions, or kidney failure

  • who have had an allogenic bone marrow transplant or double umbilical cord blood transplantation

  • who are taking warfarin 

What are the risks?
  • If you choose to take part in this study, there is a risk that the new drug combination may not be as good as other approaches at shrinking or stabilizing your cancer.
  • There is also a risk that you could have side effects from the new drug. Some of the most common side effects that the study doctors know about are: diarrhea, fatigue, lowering of blood cell counts (white cells and platelets), rash, bleeding, nausea, and muscle, back or joint pain. 
  • You will find details of all side effects in the consent document.
What can I expect?
  • If you choose to take part in this study, you will receive this new drug in addition to the usual treatment for 3 months followed by the new drug alone for up to 2 years of total treatment time. 
  • In this study, you will also be asked to complete questionnaires at different times, to understand your quality of life and your cognitive functions that may be impaired due to your cancer (e.g. learning, memory, and processing speed).

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 trial 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 trial will not affect your standard medical care.

The IND244 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/NCT05998642. 

Participating centres

Information coming soon.