AZTEC: phase 2 trial of azacitidine for people with chronic graft versus host disease (GvHD) after an allogeneic stem cell transplant

This trial is testing whether azacitidine is safe and effective for treating chronic graft versus host disease (GvHD) after an allogeneic stem cell transplant when steroids aren’t a suitable treatment.


Purpose of trial

Some people with blood cancers like lymphoma, leukaemia and myeloma need high-dose treatment and a stem cell transplant as part of their treatment. An allogeneic stem cell transplant uses cells from a donor (someone else). The donor cells can help to destroy cancer cells but they can also cause GvHD if they attack your own healthy cells.

Chronic GvHD starts more than 100 days after the transplant. It is usually treated with steroids but some people do not respond well to steroids or are unable to have them. Some people take steroids to treat chronic GvHD but become dependent on the steroids and cannot come off them. This trial is testing an alternative treatment for these people.


Treatments

Azacitidine is a chemotherapy drug. It is already used to treat some types of blood cancer.

Everyone in this trial has azacitidine. It can be given as a subcutaneous injection (injection under the skin) or intravenously (into a vein). Your doctor can decide which way is best for you.

Treatment is given in cycles of 4 weeks. You have azacitidine once a day for 5 days followed by a rest period before the next cycle begins. A total of 6 cycles of treatment are planned but you might have up to 4 more cycles if the treatment works well.


Who can enter

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

35 people are needed for this trial.

You may be able to enter if:

  • You have moderate or severe chronic GvHD.
  • You can’t have steroids, steroids are not working for you or you are dependent on steroids.
  • You can’t have extracorporeal photopheresis (ECP; a type of light treatment).
  • 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 and your partner are willing to use reliable contraception during treatment and for at least 3 months afterwards if there is any chance of you or your partner becoming pregnant.
  • Your blood and other health test results are satisfactory.
  • You have previously had at least 1 course of treatment for your lymphoma.
  • You are 16 or over.

You will not be able to enter if:

  • You have GvHD localised only in your eye.
  • Your GvHD is affecting your lungs.
  • You have had any treatment for your GvHD other than steroids in the last 14 days.
  • You have had another experimental treatment in the last 14 days.
  • You have had extracorporeal photopheresis (ECP; a type of light treatment) in the last 6 months.
  • You have an infection that needs treatment.
  • You have HIV, hepatitis C or hepatitis B.
  • You have any health problems that your doctor thinks might make it unsafe for you to have the trial treatment.
  • You are pregnant or breastfeeding.

Further information

More information about this trial is available at Cancer Research UK