Nivolumab for Pediatric and Adult Relapsing/Refractory ALK+, for Evaluation of Response in Patients With Progressive Disease (Cohort 1) or as Consolidative Immunotherapy in Patients in Complete Remission After Relapse (Cohort 2)
This study is investigating a drug called nivolumab for children and adults who have ALK+ anaplastic large cell lymphoma (ALCL) that has returned or isn't getting better with current treatments. We want to see how effective nivolumab is. It's split into two groups: one for patients whose cancer is actively progressing, and another for those whose cancer is in remission but are looking for a treatment to help prevent it from coming back, possibly instead of a stem cell transplant. This research is in an early stage (Phase 2), meaning we're learning more about the best way to use this treatment for ALCL.
At a glance
What is this study about?
This research study is looking at a medicine called nivolumab for people with a specific type of cancer called ALK+ anaplastic large cell lymphoma (ALCL). This is a cancer of the immune system. We're particularly interested in patients whose cancer has either come back after treatment (this is called 'relapsed') or hasn't responded well to previous treatments ('refractory').
The study has two main groups. The first group includes patients whose cancer is actively growing, even after having standard treatments like chemotherapy or other specialised drugs. For these patients, we want to see if nivolumab can help shrink the cancer or stop it from getting worse. The second group is for patients whose cancer is currently in remission (meaning there are no signs of the cancer), but who are at high risk of it returning. These patients might usually be considered for a stem cell transplant. Instead, we're exploring if nivolumab given over 24 months, can act as a preventative treatment to keep the cancer away.
The main goal is to understand how well nivolumab works in these different situations. For the first group, we're measuring how many patients respond to the treatment and see their cancer shrink or disappear. For the second group, we'll be looking at how long patients stay free from cancer progression. This is an important step in finding better ways to treat ALK+ ALCL, especially for those who haven't had success with other treatments.
Key takeaways
- This study is for children and adults with a specific type of lymphoma (ALK+ ALCL).
- It's testing a medicine called nivolumab, which is an immunotherapy.
- There are two groups: one for actively progressing cancer, and one for preventing relapse.
- The study aims to see how effective nivolumab is and its safety.
- Participation involves regular hospital visits for treatment and monitoring.
Who may be eligible?
To join this study, patients need to have been diagnosed with ALK+ anaplastic large cell lymphoma that has come back or isn't responding to other treatments. We're looking for patients generally over 6 months old. If you've recently had other treatments, you'll need to have recovered from any serious side effects before starting nivolumab.
Your body's organs, like your kidneys and liver, need to be working well, and your blood counts (white cells, red cells, and platelets) should be at a healthy level. We'll also check your general health and how active you are. If you have any questions about specific criteria, it's best to discuss them with your doctor.
Important note: For those in the second group (where the cancer is in remission), we're also checking that you haven't been on certain other treatments for too long. Your doctor will carefully review all your medical information to see if this study is potentially a suitable option 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.
- Do you have ALK+ anaplastic large cell lymphoma that has come back or isn't getting better?
- Are you generally over 6 months old?
- Have you recovered from any serious side effects of your previous treatments?
- Are your major organs (like liver and kidneys) working well, and are your blood counts generally healthy?
What does participation involve?
If you decide to take part, you will receive the study medicine, nivolumab. The treatment will last for specific periods, potentially up to 24 months for some. You will have regular visits to the hospital or clinic for assessments, which will include physical examinations, blood tests, and scans to monitor your health and how the treatment is working. We will follow up with you regularly during and after the treatment period to understand the long-term effects. The total length of your involvement will depend on which group you are in and how you respond to the treatment.
Potential risks and benefits
Locations (13)
- RigshospitaletVerified postcodeCopenhagen, Denmark
- Hôpital TrousseauVerified postcodeParis, France
- Gustave RoussyVerified postcodeVillejuif, France
- CHU Bordeaux Hopital PellegrinVerified postcodeBordeaux, France
- CHU BordeauxVerified postcodeBordeaux, France
- CHU MondorVerified postcodeCréteil, France
- Centre Oscar LambretVerified postcodeLille, France
- Centre Léon Berard LyonVerified postcodeLyon, France
- Hôpital Saint LouisVerified postcodeParis, France
- CHU Toulouse Hopital des enfantsVerified postcodeToulouse, France
- IUC ToulouseVerified postcodeToulouse, France
- CHU de nancyVerified postcodeVandœuvre-lès-Nancy, France
Common questions
What is nivolumab?
Nivolumab is a type of medicine that helps your body's immune system fight cancer cells. It's sometimes called immunotherapy.
What does 'relapsed/refractory' mean?
This means your cancer has either come back after treatment or hasn't responded to previous treatments.
What is a 'Phase 2' trial?
A Phase 2 trial is an early stage of research. It means we're still learning more about how well a new treatment works and if it's safe for specific conditions.
Will I get a placebo (dummy treatment)?
No, this study does not use a placebo. All participants will receive nivolumab.
How long will I be on the treatment?
The length of treatment varies, but for some, it could be up to 24 months, with regular checks to see how you're doing.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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