A Rollover Study for Continued Study Treatment and Ongoing Safety Monitoring
This study is designed to gather important long-term safety information about several new treatments for various cancers. These cancers include different types of leukemia (like acute myeloid leukemia and chronic lymphocytic leukemia), lymphoma, myelodysplastic syndromes, and specific solid tumours including advanced prostate cancer. This study is for people who have already taken part in an earlier study for one of these treatments. Instead of starting a new treatment, participants will continue to be monitored. This helps doctors understand how these medications affect people over a longer period, ensuring their safety and tracking their progress.
At a glance
What is this study about?
This study is called a 'rollover' study. Imagine you're on a journey with a new medicine, and once you get to a certain point, instead of stopping, you simply roll over into a new part of the journey to keep going. That's what this study is about for people who've already been part of an earlier research study for a new cancer treatment. It allows the researchers to continue checking on these patients for a longer time.
The main goal is to collect more information about how safe and well-tolerated these new treatments are over a longer period. New medicines go through many steps, and understanding their long-term effects is very important for patient safety. By continuing to monitor patients who have already started these treatments, doctors can gather crucial data that might not be obvious in shorter studies.
This ongoing monitoring will help doctors learn more about diseases like acute myeloid leukemia (a fast-growing blood cancer), non-Hodgkin lymphoma (cancer starting in infection-fighting cells), myelodysplastic syndromes (conditions where blood cells don't form properly), chronic lymphocytic leukemia (a slow-growing blood cancer), and advanced solid tumours, including advanced prostate cancer. The information gathered will be valuable for understanding how these new medicines work and for future patient care.
Key takeaways
- This study is for people already in a cancer drug trial.
- It aims to check the long-term safety of new cancer treatments.
- It helps doctors understand how treatments affect patients over time.
- Cancers include leukemia, lymphoma, and prostate cancer.
- Participation means continued monitoring, not starting a new drug.
Who may be eligible?
To be able to join this study, you must have already taken part in an earlier study for one of these experimental cancer treatments. You will need to meet all the specific rules that were set out in your original study.
It’s also crucial that you and/or your legal guardian understand what the study involves and are happy to sign a consent form. This form confirms you know what you're agreeing to and are willing to follow any necessary lifestyle rules during the study.
However, you won't be able to join if your doctors feel it would risk your safety, or if you've developed serious side effects or if your cancer has worsened since your last study. Your doctor will carefully review your situation to make sure this study is right for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Did I participate in an earlier study for this specific cancer treatment?
- Do I understand and agree to the study's purpose and procedures?
- Am I willing to follow any necessary lifestyle restrictions?
- Has my doctor said my cancer isn't worsening and I don't have serious new side effects?
What does participation involve?
If you join this study, you will continue to receive the treatment you started in your previous study. The main focus will be on ongoing check-ups to monitor your health and how you are responding to the medication. This means you will have regular visits to your study doctor, likely involving blood tests, physical examinations, and conversations about how you're feeling and any side effects you might be experiencing. The specific details of your visits and tests will depend on the exact treatment you are receiving, but the overall aim is to carefully track your safety and any changes in your condition over a longer period. The total duration of your participation will depend on individual circumstances and the specific treatment plan.
Potential risks and benefits
Locations (28)
- Ghent University HospitalVerified postcodeGhent, Belgium
- Hopital Claude HuriezVerified postcodeLille, France
- CHU NantesVerified postcodeNantes, France
- Institut Gustave RoussyVerified postcodeVillejuif, France
- Arensia Exploratory MedicineVerified postcodeTbilisi, Georgia
- Alexandra HospitalVerified postcodeAthens, Greece
- Rambam Med.Center - Hematology InstituteVerified postcodeHaifa, Israel
- Rambam Medical CenterVerified postcodeHaifa, Israel
- Hadassah University Hospita Ein KeremVerified postcodeJerusalem, Israel
- National Hospital Organization Nagoya Medical CenterVerified postcodeNagoya, Japan
- The Cancer Institute Hospital of JFCRVerified postcodeTokyo, Japan
- Arensia Exploratory MedicineVerified postcodeChisinau, Moldova
Common questions
What is a 'rollover study'?
A 'rollover study' is for people who have already been in a research study for a new medicine. It allows them to continue getting their treatment and to be monitored for a longer time, instead of ending their participation after the first study finishes.
Which cancers are included in this study?
This study includes people with different types of cancers such as acute myeloid leukemia, chronic lymphocytic leukemia, non-Hodgkin lymphoma, myelodysplastic syndromes, and certain advanced solid tumours, including advanced prostate cancer.
What is the main purpose of this study?
The main purpose is to collect more information about long-term safety and side effects of the new treatments. This helps doctors understand how these medicines affect people over a longer period.
Do I get a new drug in this study?
No, you will continue to receive the same experimental treatment you were given in your previous study. This study is about continuing to monitor that treatment over time.
Who can join this study?
Only people who have already participated in an earlier study for one of these specific treatments and meet certain safety and health requirements can join this rollover study.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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