Purpose of trial
The aim of this trial is to find out how safe and effective brentuximab vedotin combined with chemotherapy is for people with certain types of peripheral T-cell lymphoma who haven’t had any previous treatment.
Brentuximab vedotin is an antibody-drug conjugate: an antibody joined to a strong anti-cancer drug. The antibody sticks to a protein called CD30 on lymphoma cells and carries the drug directly to them. It is already available to treat some types of lymphoma that have come back or not responded after previous treatment.
Cyclophosphamide and doxorubicin are chemotherapy drugs that are commonly used to treat lymphoma. Prednisolone is a steroid.
You have treatment in 21-day cycles. You have brentixumab vedotin, cyclophosphamide and doxorubicin through a drip into a vein on day 1 of each cycle. You have prednisolone as tablets that you take on days 1 to 5 of each cycle.
The results of the trial will be analysed based on the amount of a protein called CD30 that your lymphoma cells make.
Who can enter
Your consultant can give you advice on whether you might be suitable for this trial.
Around 60 people are needed for this trial.
You may be able to enter if:
- You have:
- Peripheral T-cell lymphoma not otherwise specified (PTCL-NOS)
- Angioimmunoblastic T-cell lymphoma (AITL)
- Follicular T-cell lymphoma (FTCL)
- Enteropathy-associated T-cell lymphoma (EATL)
- Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL)
- Acute-type or lymphoma-type adult T-cell leukaemia/lymphoma (ATL)
- Hepatosplenic T-cell lymphoma
- Low-grade (indolent) T-cell lymphoproliferative disorder (T-LPD) of the gastrointestinal tract
- Nodal peripheral T-cell lymphoma with T-follicular helper (TFH) phenotype
- Less than 10% of your lymphoma cells make a protein called CD30.
- You have not been treated for your lymphoma before.
- Your lymphoma is measurable by the tests used in the trial.
- You are well enough to take part in the trial.
- Your blood and other health test results are satisfactory.
- You and your partner are willing to use reliable contraception if there is any chance of you or your partner becoming pregnant.
- You are 18 or over.
You won’t be able to enter if:
- You have:
- You have any health problems that your doctor thinks might make it unsafe for you to have the trial treatment.
- You have significant peripheral neuropathy.
- You’ve been treated with brentuximab vedotin or doxorubicin before.
- Your lymphoma is in your central nervous system (CNS; brain and spinal cord).
- You have a progressive illness affecting your central nervous system (brain and spinal cord) called progressive multifocal leukoencephalopathy.
- You’ve had a significant infection within the last 2 weeks that wasn’t controlled by medicine.
- You have significant heart disease.
- You’ve had a heart attack in the last 6 months.
- You have had another cancer in the last 5 years, except certain localised cancers.
- You are allergic to any of the ingredients of the study drugs.
- You are pregnant or breastfeeding.
More information about this trial is available at https://clinicaltrials.gov/ct2/show/NCT04569032.