A trial of BI 1206 for lymphoma and leukaemia

Cancer type:

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

Status:

Open

Phase:

Phase 1/2

This trial is looking at BI 1206 to treat B cell type non Hodgkin lymphoma and chronic lymphocytic leukaemia.

Cancer Research UK supports this trial. 

More about this trial

BI 1206 is a type of biological therapy called an antibody. It works by recognising and attaching to a particular protein called CD32b. This protein is found on some cancer cells in some types of lymphoma and leukaemia

Laboratory studies show that by blocking the CD32b protein BI 1206 could stop cancer cells from growing and dividing.

Researchers want to find out if BI 1206 can help people with B cell non Hodgkin lymphoma and chronic lymphocytic leukaemia (CLL).

This trial is in 2 parts. The 1st part is to find the highest safe dose of BI 1206 to give. When the researchers know the best dose they will use it in the 2nd part.

In the 2nd part the team are comparing:

  • BI 1206
  • BI 1206 and rituximab

Rituximab is another biological therapy. It is also an antibody. It blocks a protein called CD20. Rituximab is already used to treat some types of non Hodgkin lymphoma and CLL.

In this part researchers want to find the highest safe dose of BI 1206 to give with rituximab.

The aims of this trial are to find:

  • the highest safe dose of BI 1206
  • more about the side effects of BI 1206
  • what happens to BI 1206 in the body
  • how well BI 1206 works for B cell non Hodgkin lymphoma and CLL  
  • the highest safe dose of BI 1206 to give with rituximab
  • the side effects of giving BI 1206 and rituximab together
  • how well giving BI 1206 with rituximab works 

Who can enter

The following bullet points list 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.

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

  • You have a B cell non Hodgkin lymphoma (NHL) or chronic lymphocytic leukaemia (CLL) that has stopped responding to standard treatment or came back after treatment
  • You have had at least 1 lot of treatment that included rituximab
  • You have had a sample of tissue (biopsy Open a glossary item) or blood sample taken in the past 6 months that shows your cancer cells have the CD32b protein
  • If you have NHL you have an area of lymphoma that is 1.5cm in diameter and can be measured on a scan Open a glossary item. If you have Waldenstrom’s macroglobulinaemia it can be measured using blood tests
  • You have satisfactory blood test results
  • You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
  • You are willing to use reliable contraception for a month before starting treatment, during treatment and for a year afterwards if there is any chance you or your partner could become pregnant
  • You are at least 18 years old

To join group 2 in part B of this trial, you need to have had a tissue sample or blood sample taken in the past 6 months that shows your cancer cells have the CD20 protein.

You cannot join this trial if any of these apply.

Cancer related

  • You have lymphoma or leukaemia in the brain or spinal cord that is causing symptoms or is getting worse
  • You have had a bone marrow transplant from a donor (allogeneic transplant Open a glossary item) in the past year
  • Your lymphoma has changed (transformed) from slow growing (low grade) to fast growing (high grade)
  • You have or are suspected of having Richter’s syndrome
  • You have had an anti cancer treatment in the past 4 weeks
  • You have had an experimental drug as part of a clinical trial in the past 4 weeks
  • You have ongoing side effects of treatment apart from hair loss and some mild side effects that the trial team think won’t affect you taking part
  • You have another cancer apart from successfully treated in situ carcinoma of the cervix and non melanoma skin cancer Open a glossary item or a previous cancer unless it was treated with the aim to cure andthere has been no sign of it for at least 3 years

Medical conditions

  • You have a condition called amyloid light chain (AL) amyloidosis affecting your heart or kidneys
  • You have not fully recovered from major surgery to your chest or tummy (abdomen)
  • You have HIV, hepatitis B or hepatitis C
  • You have an autoimmune disease Open a glossary item apart from diabetes type 1 and under active thyroid that is being treated with hormone replacement and skin problems such as vitiligo or psoriasis that doesn’t need treatment that reaches your whole body (systemic treatment ) for example tablets
  • You have congestive heart failure or another heart problem such as an abnormal heart rhythm
  • You have an ongoing infection that needs treatment
  • You have any other medical or mental health condition that the trial team think could affect you taking part
  • You are taking more than 10mg of steroids a day

General

  • You are allergic to any of the drugs, or any of their ingredients, used in this trial
  • You can’t have rituximab (for people in part B who might have rituximab only)
  • You are, or plan to take part, in another clinical trial
  • You are pregnant or breastfeeding

Trial design

This is a phase 1/2 trial. The researchers need 81 people to join.

There are 2 parts to this trial.

Part A

The first few people taking part will have a low dose of BI 1206. If they don’t have any serious side effects, the next few people will have a higher dose. And so on, until they find the highest safe dose. This is called a dose escalation study.

The team will use this dose of BI 1206 in part B.

Part B

People in this part are put into 1 of 2 groups. You are put into the groups according to whether your B cell non Hodgkin lymphoma or CLL cells have the CD20 protein. The 2 groups are:

  • BI 1206
  • BI 1206 and rituximab

Trial Diagram

In the group having rituximab the researches need to find the best dose of BI 1206 to give with rituximab. They do this the same way as in part A.

You have BI 1206 as a drip into a vein every week for 4 weeks. You have rituximab in the same way on the same day.

You have an extra treatment of rituximab a week before starting BI 1206 if you have CLL and you are in the BI 1206 and rituximab group.

After 4 weeks you have a scan or blood test to see how your lymphoma or leukaemia is responding. You continue having treatment every 2 months for up to a year if it is helping you and the side effects aren’t too bad.

Blood and tissue samples

The researchers will ask for a sample of lymph node Open a glossary item tissue that was removed when you had a biopsy Open a glossary item. If this isn’t available your doctor will take a new biopsy. The team will use this sample to find out if your cancer cells have the CD32b protein.

You have another biopsy done a week after your 4th treatment of BI 1206. You don’t have to agree to have this one taken if you don’t want to. You can still take part in the trial.

During the trial you have several blood tests. The researchers use these to find out what happens to BI 1206 in the body.

Hospital visits

You see the doctor to have some tests before taking part. These tests include:

You see the doctor regularly during the first 5 weeks of treatment for blood tests, urine tests and to see how you are.

At 8 weeks you see the doctor for:

  • a physical examination
  • blood tests
  • urine test
  • eye test
  • bone marrow test (if needed)
  • CT scan
  • PET scan (if needed)

You then see the doctor every 2 months for a year. You have the same tests apart from the eye test and PET scan.

A year after the end of the trial you see the doctor for the same tests you had at the start. 

Side effects

This is the first time BI 1206 has been used in a clinical trial. During your treatment you will see the doctor regularly and have blood tests to monitor you for any side effects. You need to tell your doctor or nurse immediately if you feel unwell or different to how you usually feel while having BI 1206. As BI 1206 is a new drug there might be side effects we don’t know about yet.

The possible side effects of BI 1206 might include:

  • a reaction while having BI 1206 causing shivering, shortness of breath and chills
  • a drop in the number of white blood cells causing an increased risk of infection
  • the body’s immune system Open a glossary item making antibodies Open a glossary item that act against BI 1206
  • headaches
  • dizziness
  • fainting
  • changes to your eye sight

BI 1206 is like rituximab and the researchers expect the side effects to be similar.

We have information on the side effects of rituximab.

Your doctor will talk to you about the side effects of BI 1206 and rituximab before you agree to take part.

Location

Leicester
Manchester
Oxford
Southampton

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

Dr Andrew Davies

Supported by

Cancer Research UK (Centre for Drug Development)
Bloodwise
BioInvent International AB

Other information

This is Cancer Research UK trial number CRUKD/16/001.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

14371

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

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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