Purpose of trial
The trial is in two parts:
- The first part of the trial aims to find the best dose of JNJ-64264681 to use for people with B-cell non-Hodgkin lymphoma or chronic lymphocytic leukaemia (CLL) that has come back (relapsed) or not responded (refractory) after previous treatment.
- The second part aims to test the safety of the dose of JNJ-64264681 selected in the first part in people with relapsed or refractory B-cell non-Hodgkin lymphoma or chronic lymphocytic leukaemia (CLL).
Everybody in the trial has treatment with JNJ-64264681. You have it as capsules that you take by mouth.
JNJ-64264681 is a targeted treatment that blocks a protein called ‘BTK’ on B cells (the type of white blood cells that become abnormal in B-cell lymphomas). BTK is part of a pathway that helps B cells to stay alive and divide. Blocking BTK can make B cells die or prevent them dividing.
Part 1 of the trial is to find out the highest safe dose of JNJ-64264681. This is done by ‘dose escalation’. The first participants have the lowest dose. They have blood tests to measure the level of the drug in their body and they are carefully monitored for side effects. If the lowest doesn’t cause troublesome side effects, the next participants have a slightly higher dose. This continues until an effective and safe dose is reached. The highest dose of JNJ-64264681 that doesn’t cause serious side effects is used in part 2 of the trial.
Who can enter
Your consultant can give you advice on whether you might be suitable for this trial.
Around 108 people are needed for this trial.
You may be able to enter if:
- You have B-cell non-Hodgkin lymphoma or chronic lymphocytic leukaemia (CLL).
- Your lymphoma has come back (relapsed) or not responded (refractory) after previous treatment.
- You are well enough to take part in the trial.
- Your blood and other health test results are satisfactory.
- Your heart tracing (ECG) is satisfactory.
- You are not pregnant.
- You are not planning to donate any eggs for at least 30 days after having study treatment.
- You and your partner are willing to use reliable contraception if there is any chance of you or your partner becoming pregnant.
- You are 18 or over.
You won’t be able to enter if:
- Your lymphoma is in your central nervous system (CNS; brain and spinal cord).
- You have been unable to tolerate treatment with BTK inhibitors (for example, ibrutinib or acalabrutinib) in the past.
- You still have significant side effects from previous cancer treatment.
- You’ve recently had treatment as part of another clinical trial.
- You’ve had an organ transplant in the past.
- You are pregnant or breastfeeding.
- You are allergic to any of the ingredients of the study drug.
More information about this trial is available at clinicaltrials.gov/ct2/show/NCT04210219