Pembrolizumab and Brentuximab Vedotin vs GDP and Stem Cell Transplant for Relapsed/Refractory Hodgkin Lymphoma
This clinical trial is designed for people with Hodgkin lymphoma that has either come back after treatment (relapsed) or hasn't responded to earlier treatments (refractory). This type of situation is often called 'salvage treatment'. The main goal is to find out if a combination of two newer medications, pembrolizumab and brentuximab vedotin, is more effective than the usual treatment, which typically involves a mix of drugs called Gemcitabine, Dexamethasone, and Cisplatin (GDP), followed by a stem cell transplant. Researchers want to see if these new drugs can shrink or get rid of the lymphoma better, helping people feel well and live longer with fewer side effects.
At a glance
What is this study about?
When Hodgkin lymphoma comes back or doesn't respond to initial treatments, it can be a worrying time. Doctors then look for what's called a 'salvage treatment' to try and get the cancer under control again. The standard approach for this situation often involves a combination of medications known as GDP (Gemcitabine, Dexamethasone, and Cisplatin), which aims to shrink the lymphoma and reduce symptoms. This standard treatment is available through healthcare providers in the UK and is often followed by a stem cell transplant.
This study is exploring an alternative approach. Instead of the standard GDP treatment, it's testing two newer drugs: pembrolizumab and brentuximab vedotin. These drugs work in different ways to target cancer cells. Pembrolizumab helps your body's immune system fight the cancer, and brentuximab vedotin is a targeted treatment that delivers a cancer-killing drug directly to the lymphoma cells.
The main aim of this research is to see if the combination of pembrolizumab and brentuximab vedotin is a better option than the usual GDP treatment. 'Better' could mean shrinking the lymphoma more effectively, keeping it away for longer, or having fewer difficult side effects. By comparing these treatments, the researchers hope to improve care for people with Hodgkin lymphoma that has relapsed or not responded to previous treatments.
Key takeaways
- This study is for Hodgkin lymphoma that has returned or not responded to previous treatment.
- It compares two new drugs (pembrolizumab and brentuximab vedotin) against standard treatment (GDP and stem cell transplant).
- The goal is to find out if the new drugs are more effective and safer.
- Participation involves regular check-ups, blood tests, and scans to monitor your health and the treatment's effects.
- It's a Phase 2 study, meaning it's still in an earlier stage of testing, looking at effectiveness and safety.
Who may be eligible?
To join this study, you must have Hodgkin lymphoma that has either come back after previous treatment or hasn't responded to it. You also need to be well enough to have strong chemotherapy and a stem cell transplant, and be at least 18 years old.
There are also some health requirements, such as having good general health, a decent life expectancy, and your blood tests (like white blood cells, platelets, and liver and kidney function) need to be within a healthy range. You'll also need to be able to complete some health and quality of life questionnaires.
You wouldn't be able to join if you've already had a different 'salvage' treatment for your lymphoma, or if you have certain nerve problems or severe breathing difficulties. Women who could become pregnant and men whose partners could become pregnant will need to use effective contraception during and for about 6 months after the study treatment.
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 I have Hodgkin lymphoma that has come back or not responded to previous treatment?
- Am I at least 18 years old?
- Am I well enough to potentially have strong chemotherapy and a stem cell transplant?
- Are my blood tests (like blood counts, liver, and kidney function) generally within a healthy range?
- Have I not received any other 'salvage' treatment for my relapsed/refractory lymphoma already?
- Am I willing and able to use contraception if required during the study?
What does participation involve?
If you decide to take part, you'll first have a thorough check-up to make sure the study is right for you. This will involve various tests and scans. You'll then receive either the standard treatment (GDP followed by a stem cell transplant) or the new combination of pembrolizumab and brentuximab vedotin. The doctors will monitor you closely with regular appointments, blood tests, and scans to see how you're responding to the treatment and to check for any side effects. You'll also be asked to complete questionnaires about your health and how you're feeling. The total duration of your participation will depend on how you respond to treatment and the specific study plan, but it will involve regular follow-ups for a period of time after your main treatment ends.
Potential risks and benefits
Locations (18)
- Concord Repatriation General HospitalVerified postcodeConcord, Australia· Recruiting
- Shoalhaven Cancer Care CentreVerified postcodeNowra, Australia· Recruiting
- Wollongong HospitalVerified postcodeWollongong, Australia· Recruiting
- Royal Adelaide HospitalVerified postcodeAdelaide, Australia· Recruiting
- Austin HospitalVerified postcodeHeidelberg, Australia· Recruiting
- Sir Charles Gairdner HospitalVerified postcodePerth, Australia· Recruiting
- Arthur J.E. Child Comprehensive Cancer CentreVerified postcodeCalgary, Canada· Recruiting
- BCCA - VancouverVerified postcodeVancouver, Canada· Recruiting
- Dr. H. Bliss Murphy Cancer CentreVerified postcodeSt. John's, Canada· Recruiting
- QEII Health Sciences CentreVerified postcodeHalifax, Canada· Recruiting
- Juravinski Cancer Centre at Hamilton Health SciencesVerified postcodeHamilton, Canada· Recruiting
- London Health Sciences Centre Research Inc.Verified postcodeLondon, Canada· Recruiting
Common questions
What is Hodgkin lymphoma?
Hodgkin lymphoma is a type of cancer that starts in white blood cells called lymphocytes, which are part of your immune system. It can affect your lymph nodes and other parts of your body.
What does 'relapsed or refractory' mean?
'Relapsed' means the cancer has come back after treatment. 'Refractory' means the cancer hasn't responded to previous treatments and is still active.
What is a stem cell transplant?
A stem cell transplant involves giving you high doses of chemotherapy to kill cancer cells, which also destroys healthy blood-forming cells. Then, healthy stem cells (usually your own, collected earlier) are put back into your body to help you make new blood cells.
Are pembrolizumab and brentuximab vedotin new drugs?
Yes, they are newer types of cancer medicines. Pembrolizumab helps your immune system fight cancer, and brentuximab vedotin is a targeted drug that delivers medication directly to cancer cells.
Will I know which treatment I'm getting?
The study design will explain whether you'll know which treatment you are receiving (this is called 'open-label') or if it will be decided by chance, like flipping a coin, (this is called 'randomised'). Your doctor can explain the details.
How to find out more
Annette Hay
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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