PIX-R: a phase 3 trial to see how well pixantrone works for people with relapsed or refractory diffuse large B cell lymphoma or grade 3 (fast growing) follicular lymphoma

This trial is comparing treatment regimens for people with diffuse large B-cell lymphoma (DLBCL) or grade 3 (fast-growing) follicular lymphoma who need more treatment but can't have a stem cell transplant.


Purpose of trial

DLBCL and grade 3 follicular lymphoma are usually treated with chemo-immunotherapy - chemotherapy in combination with the antibody treatment rituximab . If the lymphoma relapses (comes back) or is refractory (doesn’t respond) to treatment, your doctor might recommend a stem cell transplant . However, a stem cell transplant is an intensive treatment and not everyone is fit enough to have it. In such case, you might have chemo-immunotherapy with a regimen (combination of drugs) like gemcitabine and rituximab.

The aim of this trial is to look at how well pixantrone (a chemotherapy drug) and rituximab work compared with gemcitabine and rituximab.


Treatments

Participants are randomised to decide which chemo-immunotherapy regimen they have:

  • gemcitabine and rituximab
  • pixantrone and rituximab.

You can’t choose which treatment you have and neither can your doctor. You are told which treatment you are having and given information about it. You have the drugs intravenously (through a drip into a vein) in 4 week cycles for up to 6 cycles. In each 4 week cycle, you have:

  • rituximab once every 4 weeks
  • pixantrone or gemcitabine once a week for 3 weeks then 1 week without treatment.

Who can enter

Your consultant can give you advice on whether this trial might be suitable for you.

Around 260 people are needed for this trial

You may be able to enter if:

  • You have DLBCL (including DLBCL that has transformed from a slower-growing type of lymphoma) or grade 3 follicular lymphoma.
  • You’ve already had treatment for your lymphoma and it included rituximab.
  • You must have responded to a previous treatment with anthracycline chemotherapy and your response must have lasted at least 12 weeks.
  • You can’t have high-dose chemotherapy and a stem cell transplant.
  • Your blood and other health test results are satisfactory.
  • You are 18 or over.

You will not be able to enter if:

  • You’ve had too much treatment with doxorubicin chemotherapy (the trial team can advise if this is the case for you).
  • You’ve had another experimental drug in the last 4 weeks.
  • You are being treated with other anti-cancer drugs or immunosuppressive drugs (drugs that lower your immune system).
  • You have any health problems that your doctor thinks might make it unsafe for you to have the trial treatment.
  • You’ve had a previous cancer in the last 5 years, unless it was one from a group of certain localised cancers.
  • You can’t have the study drugs because of allergies or other health problems.

Further information

More information about this trial is available at clinicaltrials.gov