G029365: a phase 1/2 trial of polatuzumab vedotin, bendamustine and rituximab in people with diffuse large B-cell lymphoma that has come back (relapsed) or not responded (refractory) to treatment

This trial is testing a new drug combination containing polatuzumab vedotin in people with relapsed or refractory diffuse large B-cell lymphoma.


Purpose of trial

The aim of this trial is to test if polatuzumab vedotin, in combination with bendamustine and rituximab, is safe and effective for people with diffuse large B-cell lymphoma (DLBCL) that has come back (relapsed) or has not responded (refractory) to other treatment.


Treatments

The study is in two stages:

  • Stage 1 is a ‘safety run-in’ in a small number of people to test that the combination of drugs used in the trial is safe.
  • Stage 2 is to test how well the combination of drugs works.

Recruitment for Stage 1 of the trial has finished. The trial is still recruiting for Stage 2.

All participants in the trial have treatment with polatuzumab vedotin, bendamustine and rituximab. You have all the treatments through a drip into your vein (intravenously). Treatment is given in cycles. Each cycle is 21 days. You have up to 6 cycles of treatment.

Polatuzumab vedotin is an antibody-drug conjugate: an antibody joined to a strong anti-cancer drug, which allows the drug to be delivered directly to the cancer cells. You have polatuzumab vedotin on day 2 of your first treatment cycle and on day 1 of the rest of your treatment cycles.

Bendamustine is a chemotherapy drug. You have bendamustine on day 2 and day 3 of your first treatment cycle and on day 1 and day 2 of the rest of your treatment cycles.

Rituximab is an antibody therapy that is used for many people with B-cell non-Hodgkin lymphoma, including DLBCL. You have rituximab intravenously on day 1 of every treatment cycle.


Who can enter

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

Around 314 people are needed for this trial.

You may be able to enter if:

  • You have diffuse large B-cell lymphoma (DLBCL).
  • Your lymphoma is measurable by the tests used in the trial.
  • A biopsy sample of your lymphoma is available.
  • You have previously had at least one course of treatment for your lymphoma.
  • If you have had bendamustine before, your response to treatment lasted at least a year.
  • You are well enough to take part in the trial.
  • Your blood and other health test results are satisfactory.
  • You and your partner are willing to use reliable contraception if there is any chance of you or your partner becoming pregnant.
  • You are 18 or over.

You won’t be able to enter if:

  • You have DLBCL that transformed from a low-grade lymphoma.
  • Your lymphoma is in your central nervous system (CNS; brain and spinal cord).
  • You’ve had an allergic reaction to antibody therapy in the past.
  • Any of the study drugs are not suitable for you.
  • You are eligible for a stem cell transplant.
  • You’ve had an autologous (self) stem cell transplant in the last 100 days.
  • You’ve ever had an allogeneic (donor) stem cell transplant.
  • You’ve had any type of antibody therapy in the last 4 weeks.
  • You’ve had radiotherapy, chemotherapy, immunosuppressant treatment (treatment to dampen your immune system) or another clinical trial treatment within the last 2 weeks.
  • You’ve had CAR T-cell therapy in the last 100 days.
  • You are on steroid treatment (unless it is to treat your lymphoma).
  • You have any health problems that your doctor thinks might make it unsafe for you to have the trial treatment.
  • Your blood tests show you have abnormal kidney, liver or clotting function.
  • You have symptoms of peripheral neuropathy.
  • You have HIV, hepatitis C or hepatitis B.
  • You have an active or uncontrolled infection.
  • You are pregnant or breastfeeding, or you are planning to become pregnant in the next year.

Further information

More information about this trial is available at clinicaltrials.gov/ct2/show/study/NCT02257567

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