AZD4573: a phase 1 trial looking at a new treatment for people with relapsed or refractory lymphoma and other blood cancers

This is a phase 1 (early phase) trial of an experimental treatment. This trial is the first time this treatment has been tested in humans. You might not benefit from the treatment, but the trial will give important information about this new treatment which could help other people in the future.  This is an intensive clinical trial, which means you need to be admitted to the hospital for at least 24 hours every time you have the treatment.


Purpose of trial

The aim of this trial is to find out more about using a new treatment AZD4573 to treat lymphomas and other types of blood cancer. This trial needs people whose cancer has relapsed (come back) or is refractory (has not responded to treatment). The trial aims to find out:

  • the best dose of AZD4573 to use
  • the side effects of AZD4573
  • how well the treatment works in treating blood cancers
  • how the treatment behaves in the body.

Treatments

AZD4573 is a cell signal blocker. It works by blocking a protein called ‘CDK9’. Blocking CDK9 stops signals that keep cancer cells alive, causing your body to get rid of the cells by programmed cell death (apoptosis). 

Everyone in this trial has AZD4573. You are admitted to hospital to have the treatment. It is given by intravenous infusion (through a drip). Your medical team monitor you carefully during and after the treatment. 

Different doses are being tested in this trial. You are assigned to a dose group. Your dose might be increased or decreased depending how the treatment affects you.

You have the treatment every week or every other week for up to 8 months OR You can continue to have the treatment as long as it is benefitting you and it is not causing you serious side effects.


Who can enter

Your consultant can advise you whether this trial might be suitable for you. Note: This information is for people with lymphoma. Different criteria might apply if you have another blood cancer. 

This trial is recruiting 42 people.

You may be able to enter if:

  • You have B-cell lymphoma, T-cell lymphoma or chronic lymphocytic leukaemia (CLL). People with leukaemia, myeloma and myelodysplastic syndrome can also enter.
  • You have already had at least 2 courses of treatment for your cancer but you need more treatment.
  • You are well enough to take part in this 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 any health problems that your doctor thinks might make it unsafe for you to have the trial treatment.
  • You have had other treatment for cancer in the last 1–2 weeks depending on the treatment.
  • You have had major surgery in the last 4 weeks.
  • Your cancer is in your central nervous system (brain and spinal cord) or has been in your central nervous system in the past, or your spinal cord is being compressed by your cancer.
  • You’ve had another cancer in the past, except certain localised cancers.  
  • You still have significant side effects from your previous treatment. 
  • You have had a bad reaction to the study drug or any of its ingredients before.
  • You are pregnant or breastfeeding.

Further information

More information about this trial is available at https://clinicaltrials.gov/ct2/show/NCT03263637