A trial comparing ofatumumab and IPI-145 for leukaemia or lymphoma that has continued to grow despite treatment (IPI-145-07)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Blood cancers
Chronic leukaemia
Chronic lymphocytic leukaemia (CLL)
Leukaemia
Low grade lymphoma
Lymphoma
Non-Hodgkin lymphoma

Status:

Closed

Phase:

Phase 3

This trial is looking at drugs called ofatumumab and IPI-145 for chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL). Another name for IPI-145 is duvelisib. It is for people with CLL or SLL that has come back or continued to grow despite having other treatment.

If you have chronic lymphocytic leukaemia (CLL), white blood cells called lymphocytes are cancerous. If the cancerous lymphocytes are in your lymph nodes Open a glossary item rather than in your blood, your doctors may call it small lymphocytic lymphoma (SLL). The treatments for CLL and SLL are the same.

More about this trial

Ofatumumab is a type of biological therapy called a monoclonal antibody.  These can seek out cancer cells by looking for particular proteins.

Duvelisib is a type of biological therapy called a cancer growth blocker. It stops signals that cancer cells use to divide and grow.

In this trial, some people will have ofatumumab and some will have duvelisib.

The main aims of the trial are to find out

  • How well duvelisib and ofatumumab work for CLL or SLL that has come back after treatment
  • More about the side effects of duvelisib and what happens to it in the body
  • How these treatments affect quality of life

Who can enter

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

  • Have been diagnosed with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)
  • Have already had treatment, but either it didn’t work or your cancer has come back
  • Are not able to have drugs such as fludarabine or mercaptopurine (your doctor can tell you more about this)
  • Have an area of leukaemia that can be measured on a scan
  • Have satisfactory blood test results
  • Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
  • Are willing to use reliable contraception during treatment and for 1 month after finishing duvelisib, or 12 months after finishing ofatumumab, if there is any chance that you or your partner could become pregnant
  • Are at least 18 years old

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

  • Have CLL or SLL that has come back after having ofatumumab
  • Have CLL that has changed (transformed) into Richter’s syndrome or a type of CLL called prolymphocytic leukaemia
  • Have leukaemia or lymphoma in your brain or spinal cord
  • Have had a stem cell transplant using your own cells (autologous transplant) in the last 6 months, or a stem cell transplant using cells from another person (allogeneic transplant) at any time
  • Have already had duvelisib, or a treatment that works in the same way (your doctor can tell you more about this)
  • Have had chemotherapy or radiotherapy in the last 3 weeks
  • Have had major surgery in the last 4 weeks
  • Have had a type of treatment called a tyrosine kinase inhibitor (TKI) in the last week
  • Have had treatment as part of another clinical trial in the last 3 weeks
  • Have had a live vaccine in the last month
  • Have HIV
  • Have chronic liver disease or have ever had hepatitis B, hepatitis C
  • Have had treatment for tuberculosis in the last 2 years
  • Have a medical condition that means you can’t absorb drugs from your stomach or bowel
  • Have had any other cancer in the last 2 years apart from carcinoma in situ of the cervix, bladder cancer or prostate cancer which didn’t need treatment, or non melanoma skin cancer that was successfully treated
  • Are taking steroids or other treatment to dampen your immune system (your doctor can advise you about this)
  • Take medication to keep the number of red blood cells or clotting cells (platelets) in your blood at a normal level
  • Are having treatment for an infection (you may be able to take part if you are having treatment to prevent an infection)
  • Are allergic to ofatumumab or anything it contains
  • Take other medication that affects body substances called CYP enzymes (your doctor can tell you more about this)
  • Have any other serious medical condition or mental health problem that the trial team thinks could affect you taking part
  • Are pregnant or breastfeeding

Trial design

This is a phase 3 trial. The research team needs 300 people with CLL or SLL to join. The trial is randomised. The people taking part are put into 1 of 2 groups by a computer. Neither they nor their doctor will be able to decide which group they are in.

If you are in group 1, you take duvelisib capsules twice a day, every day. You continue to have treatment until there are signs that your leukaemia has started to get worse, or you have serious side effects. Even though you take duvelisib every day, you may hear the doctors describe cycles of treatment. The first cycle is 3 weeks of treatment, and each cycle after that is 4 weeks.

If you are in group 2, you have ofatumumab through a drip into a vein. You also have ofatumumab in treatment cycles. You have 7 cycles. The first cycle is 3 weeks long, and after that they are 4 weeks long. You have treatment 3 times during the first cycle, 4 times during the second cycle, and then once during each of the next 5 cycles. So you have 12 doses in total.

The trial team will ask you to fill out a questionnaire before you start treatment, and several times during the trial. The questionnaire will ask about side effects and how you’ve been feeling.  This is called a quality of life study.

Hospital visits

You will see the doctors and have some tests before you start treatment. The tests include

You have a physical examination, blood tests and urine tests regularly during treatment. You have a CT scan and a bone marrow test every few months.

If you have duvelisib you go to hospital

  • Twice during each of your first 2 cycles of treatment
  • Once during each of the next 5 cycles
  • Once every other cycle after that

The research team will give you duvelisib capsules to take at home in between hospital visits.

If you have ofatumumab, you go to the hospital

  • 3 times during your first cycle of treatment
  • 4 times during your second cycle
  • Once during each of the next 5 cycles

If your disease hasn’t got any worse by the time you finish treatment, you will carry on seeing the trial team and having bone marrow tests and CT scans every 6 months for up to 3 years. You also have a blood test every 3 months.

If your disease does get worse, the trial team will still want to see how you are every 6 months for 3 years, but they may be able to do this by phone.

If your CLL or SLL continues to grow while you are having treatment as part of this trial (IPI-145-07), the research team will talk to you about taking part in another trial called IPI-145-12. If you are able to join the other trial, you will have whichever treatment you didn’t have as part of this trial.

Side effects

The most common side effects of ofatumumab are

  • A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
  • An allergic reaction while you have the treatment causing a skin rash, high temperature (fever), chills, shivering (rigors), headache and feeling sick
  • Tiredness (fatigue)
  • Skin rash

As duvelisib is a new drug, there may be side effects we don’t know about yet. Possible side effects include

  • A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
  • Feeling or being sick
  • Diarrhoea
  • Tiredness (fatigue)
  • Fever
  • Lung infection (pneumonia), cough or shortness of breath
  • Temporary increase in enzymes produced by the liver
  • Headache
  • Skin rash

We have more information about ofatumumab.

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Peter Hillmen

Supported by

Infinity Pharmaceuticals, Inc
NIHR Clinical Research Network: Cancer

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

12062

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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