Many trials look at the effects of adding a new drug to the standard treatment.
Sue was diagnosed with follicular lymphoma in 2007 at the age of 61. She relapsed in 2010 and was offered the choice of standard treatment or entering a clinical trial testing the safety and effectiveness of adding a new drug to chemotherapy.
GAUDI was a phase 1 study investigating the safety and effectiveness of adding different doses of obinutuzumab to chemotherapy. Obinutuzimab is an antibody that targets CD20 on B cells. It works in a similar way to rituximab, which is often used to treat people with follicular lymphoma. The investigator decided which chemotherapy regimen each participant would receive based on their individual circumstances. Participants were randomised to determine which dose of obinutuzumab they would receive. People who responded to treatment were offered obinutuzumab maintenance every 3 months for up to 2 years.
The results of the trial suggest that obinutuzumab is safe and effective for people with follicular lymphoma. These results guided the design of larger, phase 3 clinical trials of obinutuzimab and chemotherapy to treat follicular lymphoma.
Sue says: ‘It was clearly explained to me that the drug was being trialled and that it was impossible to know at that stage if it was the best course of treatment, although the clinical team seemed to think it would be. But they stressed it had to be my decision.
Although the information I was given was easy enough to read and understand, I took it to my GP to discuss. She pointed out that my progress would be well monitored, in terms of the number of check-ups, blood tests and opportunities to see the treating team.
I entered the trial, which was a randomised trial. At the start I wanted to know which treatment pattern I would have, but once the decision had been made it really didn’t matter as long as it worked. I received obinutuzumab with CHOP chemotherapy, which put my lymphoma into remission. I then had 8 doses of maintenance obinutuzumab. I am still in remission nearly 5 years after starting on the trial.
Part of the follow-up of the trial involved having scans at 6-monthly intervals. These scans are for the purpose of the trial, not specifically for my own benefit. It was always stressed that I could leave the trial at any time. After 8 scans that I would not have had if I had not been on the trial, I have asked to have no more scans unless I need one. My check-ups now follow the same pattern as for anyone else – that is annually, or when I feel there may be a problem and ask for one. I feel happy with that decision.’