Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)
This research study is testing a new drug called Valemetostat Tosylate for people who have peripheral T-cell lymphoma, or a type of adult T-cell leukemia/lymphoma. These are cancers of certain white blood cells that have either returned after treatment or haven't gotten better with previous therapies. The main goal is to find out how safe the new drug is and how well it works to shrink the cancer or stop it from growing. Doctors will carefully monitor participants and check for any side effects. This is a Phase 2 study, meaning it's still in the earlier stages of drug testing, following initial safety checks.
At a glance
Results
Results from this study
Posted July 2024Results have been published for this study.
What is this study about?
This study is investigating a new medication called Valemetostat Tosylate. This drug is designed to treat certain types of blood cancer known as T-cell lymphomas. Specifically, it's for people whose lymphoma has either returned after they've had treatment, or hasn't responded well to the treatments they've already received. The full name of the study is a bit of a mouthful, but it essentially means they are looking at this new drug for these specific conditions.
The main purpose of this study is to see two key things: firstly, how safe the drug is (meaning, what side effects it might have and how often they occur), and secondly, how well it works to help people with these types of lymphoma. This might include checking if it can make the lymphoma shrink or stop growing.
By carefully observing patients and gathering information, the researchers hope to understand if Valemetostat Tosylate could be a helpful new treatment option for people living with these challenging forms of T-cell lymphoma.
Key takeaways
- This study tests a new drug for specific T-cell lymphomas that have returned or not responded to previous treatment.
- It aims to find out how safe and effective Valemetostat Tosylate is.
- You must be at least 18 and have one of the listed lymphoma types for eligibility.
- Participation involves regular clinic visits, blood tests, and scans.
- You can withdraw from the study at any time.
- Always discuss clinical trials thoroughly with your own doctor.
Who may be eligible?
To join this study, you need to be at least 18 years old. You must also have one of the specific types of peripheral T-cell lymphoma or adult T-cell leukemia/lymphoma that has either returned or not responded to previous treatments. A doctor will confirm your diagnosis based on your medical records.
It's important that your general health and everyday activity level are good enough to participate in the study. You also need to have at least one spot of detectable cancer that can be measured by scans, so doctors can track if the treatment is working. You will have already tried at least one other treatment for your lymphoma that didn't achieve a complete response, or the cancer came back after treatment.
The study team will carefully review your medical history and test results to make sure it's safe for you to take part and that the study is the right fit for your situation. You'll also need to sign a consent form, showing you understand what's involved and agree to take part.
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.
- Are you 18 years old or older?
- Do you have a type of peripheral T-cell lymphoma or adult T-cell leukemia/lymphoma that has come back or not responded to previous treatment?
- Has your general health been considered good enough for a clinical trial (doctors use something called a 'performance status' to check this)?
- Do you have at least one measurable area of cancer that can be seen on scans?
What does participation involve?
If you decide to join this study, you would receive the study medication, Valemetostat Tosylate. You would have regular visits to the hospital or clinic for check-ups, blood tests, and scans to monitor your health and how the treatment is working. This will include keeping an eye on any side effects you might experience. The exact number of visits and tests will be explained to you by the study team.
During the study, doctors will closely monitor your progress using scans like CT or MRI to measure the lymphoma. There will also be follow-up appointments after you stop taking the medication, to ensure your health is still being monitored. The total length of your participation will depend on how you respond to the treatment and the study's protocol, but the study team will be able to give you more specific details.
Potential risks and benefits
Locations (60)
- City Of Hope National Medical CenterVerified postcodeDuarte, United States
- Stanford University Medical Center - Cancer Clinical Trials Office - ONCOLOGYVerified postcodePalo Alto, United States
- University of California San FranciscoVerified postcodeSan Francisco, United States
- University Of Colorado Cancer CenterVerified postcodeAurora, United States
- Emory University Hospital - Winship Cancer InstituteVerified postcodeAtlanta, United States
- Northwestern University - Feinberg School of MedicineVerified postcodeChicago, United States
- Dana Farber Cancer InstituteVerified postcodeBoston, United States
- Mayo Clinic - RochesterVerified postcodeRochester, United States
- Washington University School of MedicineVerified postcodeSt Louis, United States
- Hackensack University Medical Center - John Theurer Cancer CenterVerified postcodeHackensack, United States
- Memorial Sloan-Kettering Cancer Center at Memorial HospitalVerified postcodeNew York, United States
- Weill Cornell MedicineVerified postcodeNew York, United States
Common questions
What is peripheral T-cell lymphoma?
It's a group of rare cancers that affect certain white blood cells called T-cells, which are part of your immune system.
What does 'relapsed/refractory' mean?
It means your cancer has either come back after treatment (relapsed) or it hasn't responded well to previous treatments (refractory).
What is Valemetostat Tosylate?
It's a new experimental drug being tested in this study to treat certain types of T-cell lymphoma.
Will I get the actual drug or a placebo?
In this specific study, all participants will receive the study drug, Valemetostat Tosylate; there is no placebo group.
How long will I be in the study?
The length of your participation will depend on your response to the treatment and the study plan, which your doctor will explain in detail.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.