Blinatumomab consolidation: a phase 2 trial testing a new antibody drug after chemotherapy for people with newly diagnosed high-risk diffuse large B-cell lymphoma

This trial is testing whether giving blinatumomab after standard treatment can reduce the risk of relapse (lymphoma coming back) for people with diffuse large B-cell lymphoma (DLBCL) that is at high risk of relapse after treatment.. 


Purpose of trial

Giving blinatumomab after standard treatment could help to reduce the risk of DLBCL coming back. 

This trial is testing:

  • the safety of blinatumomab
  • how effective blinatumomab is
  • how blinatumomab moves through the body.

DLBCL is usually treated with chemotherapy together with the antibody treatment rituximab. Some people are at high risk of their DLBCL relapsing (coming back) even after successful treatment. This includes, for example, people with a double-hit lymphoma (lymphoma with two major genetic changes) or who have a high prognostic score using the International Prognostic Index (IPI), which takes several different risk factors into account.


Treatments

Blinatumomab is a type of antibody called a ‘bispecific T-cell engager’ or BiTE. It attaches to a protein called ‘CD19’ on lymphoma cells and also attaches to T cells (cells of your immune system) so your own immune system can destroy the lymphoma cells.

Everyone in this trial has standard treatment for DLBCL of chemo-immunotherapy (chemotherapy with the antibody treatment rituximab). You can have one of the following regimens (combinations of drugs):

  • R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisolone)
  • DA-EPOCH-R (dose-adjusted etoposide, prednisolone, vincristine, cyclophosphamide, doxorubicin, rituximab)
  • R-CHOEP (R-CHOP with etoposide).

Your doctor can choose the most appropriate regimen (combination of drugs) for you.

If you respond to standard treatment (your lymphoma stays the same or is reduced by the treatment), you can have blinatumomab as part of this trial.

If you do not respond to standard treatment, you and your doctor can consider other treatment options.

Blinatumomab is given through a central line - a thin tube that goes into a central vein in your chest and that stays in place throughout your treatment. The drug is given continuously over 8 weeks. It is given into your central line through a pump that you can attach to a belt. The trial team can give you more information about looking after the pump and your central line.

After 8 weeks, you then have a 4-week break from treatment.

If your doctor thinks the blinatumomab treatment is helping, you might then have a second 8-week treatment.


Who can enter

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

A total of 38 people are needed for this trial.

You may be able to enter if:

  • You have untreated diffuse large B-cell lymphoma (DLBCL) with high-risk features (IPI score 3–5, double-hit or higher protein expression).
  • Your lymphoma was diagnosed by biopsy.
  • Your lymphoma is suitable for treatment with standard chemo-immunotherapy of R-CHOP, DA-EPOCH-R or R-CHOEP.
  • Your lymphoma is measurable by the tests used in the trial.
  • You are well enough to look after yourself and are up and about more than 50% of your waking hours, even if you are not well enough to work.
  • Your blood and other health test results are satisfactory.
  • You are 18 or over.

To have blinatumomab, your lymphoma must stay the same or be reduced by standard treatment. If your lymphoma gets worse, you end the trial and your doctor can discuss other treatment options with you.

You will not be able to enter if:

  • Your lymphoma is in your central nervous system (CNS; brain and spinal cord) or you have a significant problem that affects your CNS eg epilepsy, stroke, severe brain injury, etc.
  • You have or have had an autoimmune disease (where your immune system attacks your own body) that could affect your CNS.
  • You have an infection that needs systemic (whole-body) treatment.
  • You have had an anti-CD19 drug before.
  • You have HIV, hepatitis C virus or hepatitis B virus.
  • You have had another cancer in the last 3 years, except certain localised cancers.
  • Any of the study drugs are not suitable for you.
  • Your doctor thinks you have any health problems that would make it unsafe for you to have the study treatment.
  • You have had another experimental treatment in the last 30 days.
  • You are pregnant or breastfeeding or unwilling to use effective contraception during treatment and for at least 48 hours after the last dose of blinatumomab.

Further information

More information about this trial is available at clinicaltrials.gov.