Purpose of trial
The aim of the trial is to investigate a new drug called Betalutin and find out:
- the maximum dose that can be given safely
- about the potential side effects
- how well it works for certain types of non-Hodgkin lymphoma that have relapsed (come back) since they were first treated.
Betalutin is a radio-immuno conjugate, which is an antibody attached to a radioactive molecule. The antibody binds (sticks) to lymphoma cells and brings the radiation directly to them, which kills them. The antibody in Betalutin binds to CD37, which is found on several different types of B-cell lymphoma cells, including:
- follicular lymphoma
- marginal zone lymphoma
- small lymphocytic lymphoma
- lymphoplasmacytic lymphoma
- mantle cell lymphoma.
This trial is divided into 2 parts.
Part 1 is to find out the highest safe dose of Betalutin. This is done by dose escalation. Participants are treated in groups of 3. The first 3 participants have the lowest dose. The next 3 have a higher dose. This continues and the participants are monitored closely for side effects. The highest dose that doesn’t cause serious side effects is used in part 2 of the trial.
Part 2 is to test how well the highest safe dose of Betalutin works. People entering this part of the trial all have the same dose. On entry to the study, participants are assigned to a group. Each group has a different treatment before they have Betalutin (a pre-dose). You might have:
- rituximab (an antibody treatment)
- HH1, which is the same antibody used in Betalutin but without the radioactive molecule
- both rituximab and HH1
- no pre-dose
If you are having a pre-dose, it is given before Betalutin on the same day. Some people also have another pre-dose 7–14 days before Betalutin. You have Betalutin and the pre-dose drugs as an injection into a vein.
Because Betalutin is a new drug, the trial team need to keep a close eye on you for a time after the treatment. Everyone in the trial has one treatment with Betalutin. You then have regular blood tests:
- on the day of treatment
- every other day for the first week after treatment
- weekly for up to 12 weeks after treatment
- monthly for up to 1 year after treatment
- once every 6 months for up to 5 years.
Who can enter
Your consultant can give you advice on whether this trial might be suitable for you.
A total of 49 people are needed for this trial.
You may be able to enter if:
- You have been diagnosed with a B cell lymphoma: follicular lymphoma (grade 1-3a), marginal zone lymphoma, small lymphocytic lymphoma, lymphoplasmacytic lymphoma or mantle cell lymphoma.
- Your lymphoma has relapsed (come back) since it was first treated.
- Your lymphoma is measurable on a scan or X-ray.
- You are at least well enough to carry out all your normal activities, apart from heavy physical work.
- You and your partner are willing to use reliable contraception if there is any chance of you or your partner becoming pregnant.
- Your blood and other health test results are satisfactory.
- You are 18 or over.
You will not be able to enter if:
- You have been treated with a similar type of drug before.
- Your lymphoma is in your central nervous system (CNS; brain and spinal cord).
- You have had a bone marrow or stem cell transplant.
- You have had extensive radiotherapy that included more than a quarter of your bone marrow.
- You have any serious illness such as uncontrolled infection, heart, lung or neurological problem that could interfere with the study treatment.
- You have asthma or allergy that needs treatment with steroids.
- You’ve had chemotherapy or immunotherapy in the last 4 weeks (you can have had rituximab).
- You have tested positive for HIV or Hepatitis B.
- You are pregnant or breastfeeding.
- Any of the study drugs are not suitable for you.
More information about this trial is available at clinicaltrials.gov.