A trial for people with leukaemia or lymphoma who have already had IPI-145 or ofatumumab (IPI-145-12)

Cancer type:

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

Status:

Open

Phase:

Phase 3

This trial is for people with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) who have already taken part in the IPI-145-07 trial.

If you have chronic lymphocytic leukaemia (CLL), white blood cells called lymphocytes are cancerous. If the cancerous lymphocytes are in your lymph nodes 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.

IPI-145 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 IPI-145. Another name for IPI-145 is duvelisib. Everyone taking part will have whichever treatment they didn’t have when they were in the IPI-145-07 trial.

The main aims of the trial are to find out

  • How well duvelisib works for people with CLL or SLL that has continued to grow while having ofatumumab
  • How well ofatumumab works for people with CLL or SLL that has continued to grow while taking duvelisib
  • More about the side effects of taking one treatment and then the other

Who can enter

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

  • Have had either duvelisib or ofatumumab as part of the IPI-145-07 trial but your leukaemia or lymphoma has now started to get worse
  • 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

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

  • Decided to withdraw from the IPI-145-07 trial before you finished treatment, or your disease didn’t get any worse while you were on that trial
  • Have CLL or SLL that started to grow again more than 3 months ago
  • Have had any other treatment for your CLL or SLL since it started to grow again that wasn’t part of the IPI-145-07 trial (you may still be able to take part if you have had steroids to help control symptoms)
  • 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
  • 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)
  • Have had a major operation in the last 4 weeks
  • Are not able to have treatment to prevent infections called pneumocystis or herpes simplex (your doctor can tell you more about this)
  • 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 HIV
  • Have chronic liver disease or have ever had hepatitis B or hepatitis C
  • 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
  • Have a medical condition that means you can’t absorb drugs from your stomach or bowel
  • 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 trial will recruit people who have already taken part in the IPI-145-07 trial. The research team needs about 150 people to join this trial.

If you had ofatumumab in the first trial, you will have duvelisib in this trial. You take duvelisib capsules twice a day, every day. 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. You may have treatment for up to 2 years, depending on how well it works and the side effects you have.

If you had duvelisib in the first trial, you will have ofatumumab in this trial. You also have ofatumumab in treatment 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

You will see the doctors and have blood tests, a CT scan and a bone marrow test after you finish treatment.

If you stop treatment for any reason other than your disease getting worse, you will carry on having blood tests every 2 months. You will continue to see the trial team and have other tests every 6 months for 2 years.

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.

Location

Bournemouth
Leeds
Manchester
Nottingham
Oxford

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

Verastem Inc

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

12722

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:

Rate this page:

No votes yet
Thank you!
We've recently made some changes to the site, tell us what you think