A trial of a monoclonal antibody called DI-B4 for low grade B cell lymphoma and chronic lymphocytic leukaemia
Cancer type:
Blood cancers
Chronic leukaemia
Chronic lymphocytic leukaemia (CLL)
Leukaemia
Low grade lymphoma
Lymphoma
Non-Hodgkin lymphoma
Status:
Results
Phase:
Phase 1
This trial looked at a new drug called DI-B4 for low grade B cell lymphoma and chronic lymphocytic leukaemia (CLL). The people taking part had lymphoma or leukaemia that was getting worse or had come back despite having other treatment.
Cancer Research UK supported this trial.
More about this trial
At the time of this trial, treatment for low grade lymphoma and CLL was chemotherapy and a drug called rituximab. But sometimes treatment doesn’t work or the lymphoma or leukaemia comes back afterwards. So, researchers are looking for ways to improve treatment. In this trial, they looked at a drug called DI-B4.
DI-B4 is a type of targeted drug called a monoclonal antibody. It targets a protein called CD19 that is often found on lymphoma and leukaemia cells. Everybody taking part in this trial had lymphoma or leukaemia that had the CD19 protein (was CD19 positive). This was the first time people had DI-B4.
The aims of the trial were to:
- find the highest safe dose of DI-B4
- find out what happens to DI-B4 in the body
- learn more about the side effects
- see how well treatment worked
Summary of results
The trial team found a safe dose of D1-B4 that didn’t cause serious side effects. And the treatment worked for a small number of people.
This was a phase 1 trial. There were 2 parts to the trial. Part 1 looked at the best dose of DI-B4. Part 2 looked at this dose in more people. 28 people took part in the trial, and:
- 16 people joined part 1
- 12 people joined part 2
Everybody taking part had DI-B4, through a drip into a vein. They had it once a week for 4 weeks.
The first person to have treatment had a low dose of DI-B4. As they didn’t have any bad side effects, the next person had a higher dose and so on, for 6 different doses. This is called a dose escalation study.
Results
The trial team looked at how well treatment worked. They had the results for 25 people who had all 4 weeks of treatment (3 people did not have all the treatment and were not included in the analysis of their cancer).
The researchers found for the people who had B cell lymphoma:
- in 3 people their lymphoma went away a little bit - we call this a partial response
- in 12 people it stayed the same - we call this stable disease
- in 6 people it had got worse
The researchers found in people who had leukaemia, it stayed the same in 4 people (stable disease).
The researchers looked at the length of time before the lymphoma or leukaemia started to grow again. They found:
- this was more than 6 months in 6 people
- this was just under 18 months in 1 person
- the average length of time before the cancer started to grow again was 157 days
The trial team followed everyone up for up to 18 months. There were 19 people from the trial alive at this time.
By taking a number of blood samples, they learnt more about what happens to the drug in the body. We call this pharmacokinetics 
.
.Side effects
26 people had a side effect that was related to treatment. The most common side effects were:
- tiredness (fatigue)
- feeling or being sick
- a reaction to the infusion
- a drop in
white blood cells
Most side effects were mild. One of the more serious side effects included
a drop in the number of blood cells such as:
- white blood cells that help fight infection
- platelets that help the blood to clot
Conclusion
The trial team found a safe dose of DI-B4. They concluded it helped some people in this trial.
We have based this summary on information from the research team. As far as we are aware, the information they sent us has not been reviewed independently (peer reviewed ) or published in a medical journal yet. The figures we quote above were provided by the research team. We have not analysed the data ourselves.
) or published in a medical journal yet. The figures we quote above were provided by the research team. We have not analysed the data ourselves.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)
Experimental Cancer Medicine Centre (ECMC)
Merck Serono
NIHR Clinical Research Network: Cancer
Other information
This is Cancer Research UK trial number CRUKD/12/003.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
Last review date
CRUK internal database number:
2456
Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.
