Purpose of trial
The aim of the trial is to find out if a new drug called vistusertib (formerly known as ‘AZD2014’) is safe and effective for people with diffuse large B cell lymphoma (DLBCL) that has relapsed (come back) or is refractory (didn’t respond to previous treatment).
Vistusertib is a targeted drug that works by blocking the action of a protein called mTOR. This protein is part of a signalling pathway that controls how cells grow and divide. In lymphoma, abnormal cells grow and divide in an uncontrolled way. Blocking the growth and division of these abnormal cells with vistusertib could cause them to die or control their growth and division.
A small number of people in the trial are given the monoclonal antibody rituximab in combination with vistusertib to see if this combination is safe and effective.
Everyone in this trial is given vistusertib tablets to be taken twice a day for 2 days a week then no drug for 5 days. You continue to follow this schedule for as long as your lymphoma is responding to treatment and you don’t have any side effects bad enough to have to stop treatment.
If you are also having rituximab, this is given intravenously (through a drip into a vein) once every 4 weeks for 6 cycles (treatments).
Who can enter
Your consultant can give you advice on whether this trial might be suitable for you.
You may be able to enter if:
- You have relapsed or refractory DLBCL and have had previous treatment with chemo-immunotherapy (chemotherapy and an antibody like rituximab).
- Your diagnosis must be confirmed by biopsy.
- Your lymphoma is measurable by the tests used in the trial.
- Your lymphoma has relapsed after a stem cell transplant or you are not suitable for a stem cell transplant.
- You are well enough to look after yourself and up and about more than 50% of your waking hours, even if you are not well enough to work.
- You and your partner are willing to use reliable contraception if there is any chance of you or your partner becoming pregnant.
- Your blood test results are satisfactory.
- You are over 18.
You will not be able to enter if:
- You’ve had other treatment in the last 2 weeks, except some radiotherapy and steroids.
- You’ve had major surgery in the last 4 weeks.
- You haven’t recovered from the side effects of your previous treatment, except for hair loss.
- You are on or have had certain drugs that might not have completely left your system.
- You’ve been treated with a related drug before.
- You have any heart problems or have had procedures on your heart in the last year.
- You have any other severe or uncontrolled condition or disease.
- You have type 1 diabetes or type 2 diabetes that is not well controlled.
- Your blood test results are not satisfactory.
- You have any problems swallowing or might have problems absorbing the drug.
- You’ve had a previous cancer, unless it was a localised cancer that was completely removed by surgery.
More information about this trial is available at clinicaltrials.gov.