Information about the GO44900 study
Helping you decide if the GO44900 study is right for you
Study objectives
The GO44900 study will evaluate the safety and effectiveness of an investigational drug when taken in combination with two approved chemotherapy drugs (gemcitabine and oxaliplatin).
The goal of this study is to help develop treatment options for people with DLBCL in the future.
We’re looking for around 50 people to take part in the GO44900 study who:
Are aged 18 years or over
Have been diagnosed with relapsed or refractory (R/R) DLBCL
Have had at least one treatment for DLBCL at any time
Are not a candidate for high-dose chemotherapy followed by autologous stem cell transplant (ASCT)
If you’re unsure whether you meet these criteria, please contact your physician or the trial support team.
Study duration and design
If you choose to join this study, your total time in the study will depend on how you respond to the study treatment. This could range from 1 day to up to 3 years. The study has three parts, as shown below.
Screening period
Up to 1 month
We’ll carry out some health checks to make sure that you and the study are a good fit.
Treatment period
Up to 9 month
If the study is right for you and you choose to join, you’ll receive the study treatment in ‘cycles’. A cycle in this study is a length of time lasting 21 days, or 3 weeks.
During the study, you’ll receive up to 12 cycles of study treatment. For up to eight of these cycles, you’ll receive the investigational drug in combination with the two approved R/R DLBCL drugs (gemcitabine and oxaliplatin). For the remaining four cycles, you will receive the investigational drug alone.
Follow-up period
Around 2 years
After your last dose of study treatment, you’ll need to visit the study clinic about 6 to 8 weeks later. After that, you’ll either visit the clinic or talk to someone from the study team on the phone every 3 months.
We’ll monitor your health for the whole time you’re in the study.
Health monitoring
Your safety is our top priority. So, if you join, we’ll ask you to visit the study clinic at least 20 times over 1 year, so that we can carefully monitor your health. However, a mobile nurse may be available to visit you at your home (or another suitable location), in place of certain clinic visits. If this service is available in your area, a member of the study team will discuss this option with you. Shorter visits may last 1–2 hours but some of the longer visits could take 8 hours or longer.
You’ll also need to have three phone calls during the study. The number of clinic visits you’ll need to attend will depend on how long you stay in the study for.
Health assessments will vary between visits and may include:
Blood tests
Physical examinations
Tumor imaging scans
Questionnaires
Potential benefits and risks for participants
Potential benefits
We cannot guarantee that your health will improve as a result of taking part in this study. Your health may improve, but it could stay the same, or even get worse. However, if you join this study, you’ll be contributing to important research that could help other people with DLBCL in the future. Furthermore, you’ll receive regular health monitoring at no cost to you.
Potential risks
Every clinical study carries an element of risk because they are evaluating drugs, or in the case of this study, a combination of approved drugs that is investigational. So while the investigational drug is approved for the treatment of R/R DLBCL on its own, the combination of the investigational drug, gemcitabine, and oxaliplatin is not approved for the treatment of DLBCL. You may also experience unwanted effects from the study drugs. However, the study doctor and their team will monitor you closely with regular health assessments. The informed consent form will provide more information about the possible risks of taking part.
Safety
Every care is taken to ensure that any potential risk remains as low as possible. Safety measures include regular health monitoring and access to care for the treatment of any unwanted effects that might arise from participating in this study.
If you have questions around safety, please contact the trial support team. They’ll be happy to answer your questions.
Data
Your personal data and medical samples (such as tumor samples) will be labeled with a unique participant identification number that is not related to or derived from information that identifies you.
If you have questions around how your data will be handled, please contact the trial support team. They’ll be happy to answer your questions.
Ethics
The term ethics, in the context of clinical research, refers to the principles and guidelines that are put in place to ensure that any person who joins a clinical study is treated fairly, and that their wellbeing is prioritized.
This study, just like other clinical studies, has strict measures in place to ensure that the study is ethical.
These include:
Approval by regulatory boards
The protocol (or plan) of every clinical study must first be approved by regulatory boards before it is allowed to take place. Important factors are considered including safety, the possible risks and benefits, and privacy.
Informed consent
Informed consent ensures that a person understands what the study will involve, including the risks and benefits, and agrees to take part in the study. This is an important part of the clinical study journey as it shows a person has control over whether or not to join a clinical study after learning what taking part will involve. The study doctor and the study team are responsible for ensuring that you are well informed about the study.
Voluntary participation
Taking part in clinical studies is entirely voluntary. It is your choice to take part in the GO44900 study and you can withdraw and leave the study at any point if you change your mind, without any impact on your regular healthcare.
Regular health monitoring
Participants will undergo regular health monitoring and assessments and will have access to care for the treatment of any unwanted effects that might arise from participating in this study.
If you have questions around ethics, please contact the trial support team. They’ll be happy to answer your questions.
Frequently asking questions (FAQs) about this study
Your study treatment will be given to you via intravenous, or IV, infusion. During an IV infusion, a member of the study team will carefully place a needle into a vein in your arm so the study treatment can go straight into your bloodstream.
After your first infusion of the investigational drug, you’ll need to stay in the hospital overnight so that we can monitor you for unwanted effects. You may also need to stay in hospital again during the study, depending on how you respond to the investigational drug. You’ll also be given additional medications an hour before each IV infusion to reduce the severity of any unwanted effects you may experience. These additional medications are called premedications.
No. If you join this study, you will receive the study drugs and undergo health monitoring at no cost to you. You do not need to have medical insurance to take part in this study. There may also be resources available to help with the financial burdens associated with taking part in this study. If you choose to take part, please ask a member of the study team for more information.
No. Joining this study is completely voluntary – you do not have to take part. If you join and change your mind, you can leave at any time without any impact on your regular healthcare.
Cytokine release syndrome (CRS) is an unwanted effect of the investigational drug that some people experience. CRS is caused by the release of small proteins called ‘cytokines.’ Cytokines tell your immune system to get to work, but sometimes the immune system overreacts and releases too many cytokines, causing inflammation throughout the body.
Most cases of CRS are mild, causing a fever that doesn’t require medical intervention, but it can sometimes lead to more serious complications. If you decide to join this study, the study team will give you more information about CRS. You will be closely monitored after you receive the investigational drug for signs of CRS. Drugs that treat CRS will be accessible to your study doctor if they are needed to treat you.
