RecruitingPHASE2INTERVENTIONAL

Phase II Trial of Individualized Immunotherapy in Early-Stage Unfavorable Classical Hodgkin Lymphoma

This study, called a Phase II trial, is investigating a new, personalised approach to treating early-stage Hodgkin Lymphoma, a type of cancer. It uses a specific drug named Tislelizumab, aiming to find an effective and well-tolerated first-time treatment. For many young people with Hodgkin Lymphoma, this trial hopes to reduce the strong side effects often seen with standard chemotherapy and radiation. Doctors want to see if they can give less intense treatment, or even no chemotherapy or radiotherapy at all, to patients who respond really well to the new drug. This could lead to a better quality of life and fewer long-term health problems for patients.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

University of Cologne

Enrolment target

120

Start

24 May 2024

Estimated completion

01 May 2028

Classical Hodgkin Lymphoma

What is this study about?

This study is a clinical trial, which means it's a carefully planned medical research study involving people. It's called a 'Phase II' trial, which means it’s looking to see how well a new treatment works and if it's safe. The treatment being studied is for a type of cancer called Classical Hodgkin Lymphoma, specifically when it's caught in its early stages but has some features that make doctors consider it 'unfavourable'.

The main idea behind this trial is to try and make the treatment for Hodgkin Lymphoma more patient-friendly. Traditional treatments like chemotherapy and radiotherapy can be very effective, but they can also cause unwanted side effects both in the short term (like feeling sick or tired) and in the long term (like damage to organs or even new cancers later in life). Since many people who get Hodgkin Lymphoma are young, finding gentler yet effective treatments is really important.

This study will use a drug called Tislelizumab. This type of drug works by helping your own body's immune system fight the cancer. Doctors are hoping that by giving Tislelizumab, they can reduce how much other strong treatments like chemotherapy or radiotherapy patients need. For some patients who respond very well, they might even be able to avoid these traditional treatments altogether, leading to a much better experience and fewer long-term health issues.

Key takeaways

Tests a new drug (Tislelizumab) for early Hodgkin Lymphoma.
Aims to reduce chemotherapy/radiation side effects.
Potentially offers a gentler, more personalised treatment.
Focuses on improving quality of life for young patients.
It's a Phase II trial, looking at how well the new treatment works and its safety.

Who may be eligible?

To join this study, people generally need to be between 18 and 60 years old. There's also a smaller group for people aged 61 or older, provided their doctor thinks they are healthy enough for certain treatments.

You must have been recently diagnosed with Classical Hodgkin Lymphoma for the first time and haven't had any treatment for it yet. Your cancer should be in an 'early stage' but have certain characteristics that doctors describe as 'unfavourable'. These unfavourable features might include having a large lump in your chest, cancer spread outside your lymph nodes, a high reading for a blood test called ESR, or cancer in three or more different areas of your body.

There are also some reasons why you wouldn't be able to join. For example, if you have a different specific type of Hodgkin Lymphoma, or if the cancer has spread to your brain or spinal cord.

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 between 18 and 60 years old (or over 61 and healthy enough)?
Have you recently been diagnosed with Classical Hodgkin Lymphoma for the first time?
Have you not had any treatment for your Hodgkin Lymphoma yet?
Do you have early-stage Hodgkin Lymphoma with some 'unfavourable' features?
Do you *not* have other specific types of lymphoma or cancer in your brain/spinal cord?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will likely have regular hospital visits for check-ups, blood tests, and scans to see how you are responding to the treatment. You will receive the study drug, Tislelizumab, according to a schedule set by the study doctors. The exact number of visits, tests, and the total length of time you'll be involved will be explained in detail by the study team. You will be closely monitored throughout the study for any side effects.

Potential risks and benefits

Potential benefits of joining this study include receiving a new and potentially less intensive treatment for your Hodgkin Lymphoma, which could lead to fewer long-term side effects compared to standard treatments. However, there's no guarantee the treatment will work for everyone, and it might not be better than current options. Like all medications, Tislelizumab can have side effects, and these will be explained to you in full before you decide to join. Your safety and well-being are paramount, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

1st Department of Medicine, Cologne University Hospital
Verified postcode
Cologne, Germany· Recruiting

Common questions

What is the main goal of this study?

The study aims to find a new, gentler way to treat early-stage Hodgkin Lymphoma, hoping to reduce the need for strong chemotherapy and radiation.

What drug is being tested?

The study is testing a drug called Tislelizumab, which works by helping your immune system fight the cancer.

Who can take part in this study?

Generally, people aged 18-60 with a new diagnosis of early-stage, 'unfavourable' Classical Hodgkin Lymphoma who haven't had treatment yet.

Will I still need chemotherapy or radiation?

The hope is that patients who respond well to Tislelizumab might need less or even no chemotherapy or radiation, but this is what the study is trying to find out.

What kind of commitment is involved?

If you join, you'll have regular hospital visits, blood tests, and scans to monitor your health and response to the treatment.

How to find out more

Michael Fuchs

ghsg@uk-koeln.de +49221478 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.