Purpose of trial
The trial is in 2 parts.
The first part of the trial was to find the best dose of acalabrutinib to use in combination with standard treatment, R-CHOP. This part of the trial has been completed.
The second part is testing how well the dose selected in part 1 works.
Acalabrutinib is a cell signal blocker that works in a similar way to ibrutinib. It is more selective than ibrutinib in its target so it is hoped that it will have a greater effect on cancer cells and cause fewer side effects.
- doxorubicin (or hydroxydaunorubicin)
- vincristine (Oncovin®)
- prednisolone (a steroid).
Everyone in this trial has acalabrutinib and R-CHOP. Part 1 is now closed but you may be able to enter part 2 of the trial.
- In part 1, 2 doses of acalabrutinib were tested. A safety review committee decided which dose of acalabrutinib should be used for the second part of the trial.
- In part 2, 15 people are given the dose of acalabrutinib selected in part 1 together with R-CHOP.
Eight cycles of treatment are given. The first 6 cycles are 21 days each. Cycles 7 and 8 are 28 days each. You have:
- R-CHOP only for cycle 1
- acalabrutinib with R-CHOP for cycles 2–6
- acalabrutinib only for cycles 7 and 8.
Acalabrutinib is taken orally (by mouth) as capsules once or twice a day (depending on dosage) every day for each cycle it is given.
R-CHOP includes intravenous drugs (given into a vein) together with tablets of prednisolone. Treatment is given on some days of each cycle followed by a rest period for your body to recover before the next cycle begins.
Who can enter
Your consultant can give you advice on whether this trial might be suitable for you.
40 people are needed for this trial.
You may be able to enter if:
- You have DLBCL that has CD20 (the target for rituximab).
- Tissue from your biopsy is available for tests.
- Your lymphoma is measurable by the tests used in the trial.
- You haven’t had any treatment for your lymphoma.
- You are fit enough to have R-CHOP with the intention of curing your lymphoma.
- Your doctor thinks you need a full course of chemotherapy.
- You are well enough to look after yourself and are up and about at least 50% of the day even if you are unable to work. You may be able to enter if you are more unwell as long as this is due to the lymphoma and not other health conditions.
- You don’t have another uncontrolled medical condition.
- Your blood and other health test results are satisfactory.
- You are willing to use reliable contraception throughout the trial and for 90 days after the last treatment of acalabrutinib.
- You are aged between 16 and 64.
You will not be able to enter if:
- You have previously been diagnosed with a low-grade non-Hodgkin lymphoma, unless you have been newly diagnosed with DLBCL and low-grade NHL cells are found in your body at the time of your diagnosis (discordant lymphoma).
- You have primary mediastinal lymphoma.
- You have primary central nervous system lymphoma.
- You’ve had a stroke or bleeding in your brain in the last 6 months.
- You have an unusual susceptibility to bleeding (eg you have haemophilia or von Willebrand disease).
- You need drugs that thin your blood (eg warfarin) or have taken such drugs in the last 7 days. You may be able to enter if you use heparin or low dose aspirin.
- You have had a B cell receptor inhibitor or BCl-2 inhibitor before (eg ibrutinib, idelalisib, venetoclax).
- You need treatment with a drug that would interfere with acalabrutinib. Your doctor can advise if this applies to you.
- You have an uncontrolled systemic (whole-body) infection.
- You have had major surgery in the last 4 weeks or haven’t yet recovered from a previous surgery.
- You have any digestive problems that mean you might not absorb acalabrutinib properly.
- You’ve had any immunotherapy (eg antibody treatments) in the last 4 weeks.
- You are taking part in another clinical trial involving treatment.
- You have significant heart problems.
- You have hepatitis B, hepatitis C or HIV.
- You are pregnant or breastfeeding.
- You have had another cancer in the last 2 years except certain localised cancers.
- You have any other problems that your doctor thinks make it unsafe for you to have the study treatment.
- You are 65 or over.
More information about this trial is available at Cancer Research UK.