frontMIND: A phase 3 trial of tafasitamab and lenolidomide, added to chemotherapy, in people with diffuse large B-cell lymphoma (DLBCL)
This trial is testing a new treatment called tafasitamab, combined with lenalidomide and immunochemotherapy, in people with DLBCL that has not been treated before.
Purpose of trial
The aim of this trial is to find out if adding tafasitamab and lenalidomide to standard treatment is beneficial for people with diffuse large B-cell lymphoma (DLBCL) who have not had treatment before and are at moderate or high risk of not responding to standard treatment.
Treatments
People who take part in this trial are put into one of two treatment groups at random:
- People in group 1 have tafasitamab and lenalidomide in addition to standard treatment with rituximab and CHOP chemotherapy.
- People in group 2 have standard treatment with rituximab and CHOP chemotherapy. They have ‘dummy drugs’ (placebo) instead of tafasitamab and lenalidomide.
You can’t choose which treatment you have and neither can your doctor. You and your doctor will not know which treatment group you are in.
Tafasitamab is an antibody therapy that sticks to a protein called CD19 on the surface of lymphoma cells. This attracts immune cells, which kill the lymphoma cells. You have it through a drip into a vein. You have it on days 1, 8 and 15 of each treatment cycle. A cycle lasts 21 days.
Lenalidomide is a targeted drug that helps your immune system attack lymphoma cells and stop them growing. Lab studies have shown that it might also boost the anti-cancer effects of tafasitamab. It is already available to treat some types of lymphoma. You have lenalidomide as tablets that you take by mouth once a day for 10 days, followed by 11 days off.
Rituximab is an antibody therapy that sticks to a protein called CD20 on B cells. You have it through a drip into your vein once every 3 weeks.
CHOP is a combination of chemotherapy drugs: cyclophosphamide, doxorubicin (or hydroxydaunorubicin), vincristine (Oncovin®) and prednisolone. You have cyclophosphamide, doxorubicine and vincristine through a drip into a vein once every 3 weeks. You take prednisolone by mouth every day for the first 5 days of each treatment cycle.
Whichever treatment group you are in, you have up to 6 cycles of treatment, depending on your response.
Who can enter
Your consultant can give you advice on whether you might be suitable for this trial.
Around 880 people are needed for this trial.
You may be able to enter if:
- You have:
- You have been diagnosed in the last 28 days.
- You have not had treatment for your lymphoma before.
- Your medical team think you have a moderate or high risk of not responding well to standard treatments.
- You have a recent biopsy sample available.
- You are well enough to take part in the trial.
- Your blood and other health test results are satisfactory.
- You are not pregnant.
- You are not breastfeeding or planning to breastfeed during the trial period.
- You and your partner are willing to use reliable contraception if there is any chance of you or your partner becoming pregnant.
- You are not planning to donate eggs or sperm during the trial period.
- You are 18 or over.
You won’t be able to enter if:
- You have any health problems that your doctor thinks might make it unsafe for you to have the trial treatment, including significant heart disease or nervous system diseases.
- You have:
- primary mediastinal B-cell lymphoma
- Burkitt lymphoma
- grey zone lymphoma
- primary effusion lymphoma
- primary cutaneous DLBCL, leg-type
- lymphoma that has transformed from a slower-growing type of lymphoma.
- Your lymphoma is in your central nervous system (CNS; brain and spinal cord).
- You have an active infection.
- You’ve had another cancer in the past, except certain localised cancers or cancer that has been cured for at least 2 years.
- You’ve had any treatment for your lymphoma, including treatment as part of another clinical trial.
- You are pregnant or breastfeeding.
- Any of the study drugs are not suitable for you.
- You’ve had a bad reaction to similar medicines in the past.
Further information
More information about this trial is available at https://clinicaltrials.gov/ct2/show/NCT04824092