A trial of navitoclax with ruxolitinib for myelofibrosis (TRANSFORM 1)

The following bullet points are a summary of the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you. 

Who can take part

You may be able to join this trial if all of the following apply. You:

• have intermediate 2 risk or high risk myelofibrosis. Your doctor will know what your risk group is.
• can fill in a form that scores your symptoms on at least 4 out of 7 days before you go into a treatment group (randomised ). And you have at least 2 symptoms that score 3 or more, or the total score of your symptoms is 12 or more. 
• have an enlarged spleen
• have satisfactory blood test results
• have had a skin test for tuberculosis (TB). The result shows you don’t have or are unlikely to have TB. 
• have a heart trace (ECG ) that shows your heartbeat is satisfactory. Your doctor will test for this. 
• can look after yourself but might not be able to do heavy physical work (performance status 0, 1 or 2)
• are willing to use contraception during treatment and for a time after if there is any chance you or your partner could become pregnant
• are at least 18 years old

Who can’t take part

Cancer related
You cannot join this trial if any of these apply. You:

• can have a stem cell transplant  or you have had a stem cell transplant using your own stem cells
• have already had treatment with a JAK2 inhibitor such as ruxolitinib. Your doctor will know this. 
• have a blood test or bone marrow test that shows your myelofibrosis has changed into leukaemia
• have chemotherapy, radiotherapy or hormone therapy within 30 days of starting the trial treatment. For certain medications such as hydroxyurea that help reduce the signs and symptoms of myelofibrosis it is 7 days. Your doctor will know which drugs these are. 
• have had a targeted drug  or an immunotherapy drug  such as interferon within 30 days of starting trial treatment or you might need to have it during the trial
• have had a drug that works the same as or in a similar way to navitoclax. Your doctor will know this. 
• had another cancer within the past 2 years. That is apart from successfully treated non melanoma skin cancer,  in situ carcinoma  of the cervix, food pipe (oesophagus) or stomach, or prostate cancer that has no symptoms, hasn’t spread and doesn’t need treatment. 

Medical conditions
You cannot join this trial if any of these apply. You:

• have HIV, hepatitis B, hepatitis C
• have an ongoing infection or have a low number of white blood cells and a high temperature
• have signs or symptoms of COVID-19 or you have been in contact with someone who has COVID-19 in the past 2 weeks of screening to take part in the trial. You might be able to join the trial after certain conditions are met. Your doctor will know about this.
• are having medication such as warfarin that thins your blood to prevent clots within 3 days of starting trial treatment or you need to take it during the trial. This is apart from low dose aspirin and low molecular weight heparin. 
• have had an experimental drug as part of another clinical trial within 30 days of starting the trial treatment
• are allergic or sensitive to the drugs used in the trial or any of their ingredients
• have any other medical condition or mental health problem that might affect you taking part

Other
You cannot join this trial if any of these apply. You:

• have had a live vaccine  within 4 weeks of starting trial treatment or you might need to have a live vaccine during treatment or in the 4 weeks after treatment. The COVID-19 vaccines aren’t live vaccines. 
• are pregnant or breastfeeding