B-MIND: a phase 2/3 trial testing bendamustine and a new antibody drug MOR208 against bendamustine and rituximab in people with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)

This trial is testing a new treatment for people with diffuse large B-cell lymphoma (DLBCL) who have no other treatment options after their lymphoma has relapsed (come back) or didn’t respond to previous treatment (refractory).


Purpose of trial

The aim of this trial is to compare the safety and effectiveness of the antibody treatment rituximab, and a new antibody treatment called MOR208, when given with bendamustine chemotherapy for people with DLBCL.


Treatments

There are 2 different treatment regimens (combinations of drugs) in this trial:

  • rituximab and bendamustine
  • MOR208 and bendamustine.

Rituximab is an antibody treatment that is used for many people with B-cell non-Hodgkin lymphoma , including DLBCL.

MOR208 is an experimental treatment. It is an antibody that targets a protein called CD19 found on B lymphocytes (B cells), which are the cells that are abnormal in DLBCL.

Bendamustine is a chemotherapy drug.

Participants are randomised to decide which treatment they receive. You cannot choose which treatment you receive and neither can your doctor. You are told which treatment you are receiving and given information about it.

Treatment is given in 4-week cycles for up to 24 cycles (2 years). You have all the drugs intravenously (into a vein).


Who can enter

The trial team at one of the hospitals mentioned below can advise you whether you are suitable for this trial and whether any other conditions or treatments you have or have had prevent you from entering the trial.

330 people are needed for this trial.

You may be able to enter if:

  • You have DLBCL that has relapsed (come back) or is refractory (not responding to treatment), including T-cell/histiocyte-rich large B-cell lymphoma, DLBCL that has transformed (changed) from a low-grade lymphoma and lymphoma that has features of more than 1 type of lymphoma, including DLBCL.
  • You have had 1–3 previous systemic (whole-body) treatment for DLBCL including a CD20 antibody (for example rituximab).
  • A sample of your biopsy is available for tests.
  • 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.
  • You have already had an autologous stem cell transplant or you are not able to have one.
  • 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:

  • You have a type of lymphoma other than DLBCL or you have primary mediastinal large B-cell lymphoma.
  • Your DLBCL didn’t respond well to your first treatment (primary refractory).
  • You have double-hit or triple-hit lymphoma (your lymphoma cells have 2 or more major changes to the genes).
  • Your lymphoma is in your central nervous system (CNS; brain and spinal cord) or was in your CNS in the past.
  • You’ve had other treatment in the 14 days before starting the trial treatment, including anti-cancer treatment, a live vaccine or intravenous antibiotics for an infection.
  • You’ve had a major surgery in the 30 days before starting the trial treatment.
  • You have been treated with a similar drug before, including anti-CD19 antibodies or bendamustine.
  • You’ve had a bad reaction to any of the ingredients of the treatments in the past.
  • You’ve had an autologous stem cell transplant in the last 3 months.
  • You’ve ever had an allogeneic stem cell transplant.
  • You are participating in a clinical trial of another experimental treatment.
  • You have HIV (if already known), hepatitis B or hepatitis C.
  • You have had another cancer in the last 3 years (this has certain exceptions – the trial team can advise if this applies to you).
  • You have any other health problems that your doctor thinks make it unsafe for you to take part in the trial.

Further information

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