INCA: a phase 2 trial testing inotuzumab ozogamicin and gemcitabine with chemo-immunotherapy for people with diffuse large B-cell lymphoma (DLBCL) who have not yet been treated and can’t have standard treatment

The aim of the trial is to compare inotuzumab ozogamicin and R-CVP with gemcitabine and R-CVP to find out which works best for people with diffuse large B-cell lymphoma (DLBCL) who can’t have standard treatment. 


Purpose of trial

People with DLBCL are usually treated with the chemo-immunotherapy regimen (combination of drugs) R-CHOP, which includes:

However, some people can’t have R-CHOP as it can affect the heart. These people normally have a different chemo-immunotherapy regimen, R-CVP (rituximab, cyclophosphamide, vincristine and prednisolone) which is not as effective as R-CHOP.

Adding the chemotherapy drug gemcitabine to R-CVP can improve its effectiveness.

Researchers think a new targeted drug, inotuzumab ozogamicin, might improve the effectiveness of R-CVP further.


Treatments

Inotuzumab ozogamicin is an antibody-drug conjugate.  Calicheamicin (a strong anti-cancer drug) is joined to an antibody that binds to CD22, a protein on the surface of B cells (the type of cell that is abnormal in DLBCL). The antibody takes the drug directly to the B cells, avoiding effects on other types of cell.

You may be given steroids prior to being randomised to one of the 2 treatment regimens (combinations of drugs) in the trial.

Participants are randomised to receive one of the following treatments:

  • inotuzumab ozogamicin with R-CVP
  • gemcitabine with R-CVP.

You can’t choose which treatment you have and neither can your doctor. Your doctor tells you which treatment you are having and you are given information about it.

You have most of the drugs intravenously (through a drip into a vein); only prednisolone is given as tablets.

The drugs are given in 3 week cycles. You have treatment on some days, followed by a rest period to allow your body to recover before the next cycle. You have up to 6 cycles of treatment with 2 further cycles of rituximab alone.


Who can enter

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

Around 132 people are needed for this trial.

You may be able to enter if:

  • You have DLBCL and the B cells have CD20 on their surface.
  • Your lymphoma is measurable by the tests used in the trial.
  • You haven’t had treatment for DLBCL yet, except for certain steroids.
  • You can’t have chemotherapy that contains anthracyclines (like CHOP). Your doctor can tell you if this is the case.
  • 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 and other health test results are satisfactory. You are 18 or over.

You will not be able to enter if:

  • Your DLBCL is in your central nervous system (brain and spinal cord).
  • You’ve previously been diagnosed with a low-grade (slow-growing) lymphoma and you have had treatment that reaches the whole body (systemic therapy), such as chemotherapy.
  • You have any health problems that your doctor thinks might make it unsafe for you to have the trial treatment.
  • You have had another cancer and are still having side effects from treatment or there is a 1 in 10 chance (10%) or more of your cancer coming back.
  • You have problems with your liver.
  • Your doctor thinks you have a problem with alcohol.
  • You’ve had a bad reaction to an antibody treatment in the past.
  • You are pregnant or breastfeeding.
  • You have HIV, Hepatitis B or Hepatitis C.

Further information

More information about this trial is available at clinicaltrials.gov