RecruitingPHASE3INTERVENTIONAL

International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma

This research study is for children and teenagers under 18 who have recently been diagnosed with lymphoblastic lymphoma, a type of cancer. The main goal is to find better ways to treat this condition. Researchers are comparing different chemotherapy drugs and treatment plans, specifically looking at whether certain steroid medications (like dexamethasone vs. prednisone) can help prevent the cancer from coming back in the brain or spinal cord. They also want to see if a more intensive treatment plan improves outcomes for patients with a higher-risk form of the cancer. The study is running in several countries, including the UK, and aims to improve the chances of recovery and quality of life for young patients.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

University Hospital Muenster

Enrolment target

683

Start

23 Aug 2019

Estimated completion

22 Apr 2030

Lymphoblastic Lymphoma, Childhood

What is this study about?

This important study is designed for children and teenagers under 18 who have just been told they have a type of cancer called lymphoblastic lymphoma. The main idea behind the study is to find the best possible treatment methods. Researchers are comparing different ways of giving treatment to see which ones work best to prevent the cancer from returning and to help patients live longer and healthier lives.

One part of the study focuses on a specific early treatment phase. All patients in this part will either receive a standard steroid medication called prednisone, or a slightly different one called dexamethasone. The researchers want to find out if using dexamethasone instead of prednisone can help reduce the chance of the cancer coming back in the brain or spinal cord, which is a key concern with lymphoblastic lymphoma.

For some patients who have a higher-risk form of the cancer, another part of the study compares their usual treatment with a more intensive version. This is to see if a stronger treatment plan can further improve their recovery rates. The study involves many hospitals across different countries, including the UK, working together to gather information and make treatment advancements for our young patients.

Key takeaways

This study is for children and teenagers with lymphoblastic lymphoma.
It compares different chemotherapy approaches to find better treatments.
One goal is to prevent the cancer from returning in the brain.
Participation involves receiving one of the study treatments and regular check-ups.
The study may lead to improved care for young patients with this cancer.

Who may be eligible?

This study is looking for children and teenagers who have recently been diagnosed with lymphoblastic lymphoma and are under 18 years old. You would need to be receiving your treatment at one of the hospitals taking part in this study, and both you (if old enough) and your parents or guardians would need to agree to you joining.

There are certain situations where someone might not be able to join. For example, if your lymphoblastic lymphoma is a second cancer you've developed, or if you have other serious health problems like severe heart, liver, or kidney issues, or certain infections. Also, if you've had a lot of steroid treatment recently before your diagnosis, or if you've already started other cancer treatments, you might not be eligible. The care team will check all these details carefully to make sure the 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.

Have you been recently diagnosed with lymphoblastic lymphoma?
Are you under 18 years old?
Are you being treated at a hospital involved in this study?
Have you had extensive steroid treatment in the last month before diagnosis?
Do you have other severe health conditions like serious heart, liver, or kidney problems?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive treatment for your lymphoblastic lymphoma following a specific plan. This plan involves various chemotherapy drugs (like Cyclophosphamide, Methotrexate, Vincristine, and others) given over a period of time. You will have regular hospital visits, tests, and assessments to monitor your health and how the treatment is working. Depending on your specific situation, you might be randomly assigned to different treatment groups, comparing certain medications or treatment intensities. The overall treatment duration will be determined by the study protocol, and you'll have follow-up appointments after your main treatment concludes to track your long-term health. Your doctors will explain your personal treatment journey and how long each phase is expected to last.

Potential risks and benefits

Taking part in this study might offer the potential benefit of receiving what could be a more effective treatment approach for lymphoblastic lymphoma, as researchers are trying to improve current standards. However, like all medical treatments, there are potential risks, including side effects from the chemotherapy drugs. Your medical team will explain all known side effects and monitor you closely to manage them. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (228)

Univ.Klinik für Kinder- und Jugendheilkunde Graz, Klin. Abteilung für pädiatrische Hämato-Onkologie
Verified postcode
Graz, Austria· Recruiting
Univ.Klinik für Kinder- und Jugendheilkunde Innsbruck, Universitätsklinik für Pädiatrie I
Verified postcode
Innsbruck, Austria· Recruiting
Kepler Universitätsklinikum, Med Campus IV / Onkologie
Verified postcode
Linz, Austria· Recruiting
LKH Salzburg, Universitätsklinik für Kinder- und Jugendheilkunde, Kinderonkologie
Verified postcode
Salzburg, Austria· Recruiting
St. Anna Kinderspital
Verified postcode
Vienna, Austria· Recruiting
Hôpital Universitaire des Enfants Reine Fabiola (ULB), Pédiatrie hémato-oncologie
Verified postcode
Brussels, Belgium· Recruiting
University Hospital Brussels, Pediatrische oncologie
Verified postcode
Brussels, Belgium· Recruiting
Cliniques Universitaires Saint-Luc (UCL), Hématologie et oncologie pédiatrique
Verified postcode
Brussels, Belgium· Recruiting
UZ Antwerpen Kinderhemato-oncologie
Verified postcode
Edegem, Belgium· Recruiting
University Hospital Gent Pediatrische hemato-oncologie
Verified postcode
Ghent, Belgium· Recruiting
University Hospitals Leuven, Kinderhemato-oncologie
Verified postcode
Leuven, Belgium· Recruiting
CHR Citadelle Hémato - oncologie pédiatrique
Verified postcode
Liège, Belgium· Recruiting

Common questions

What is lymphoblastic lymphoma?

It's a type of cancer that starts in white blood cells called lymphocytes, affecting the lymph nodes and sometimes other parts of the body.

Will I definitely get the new treatment?

You might be assigned to a new treatment plan or the standard one, as some parts of the study involve a random choice to see which is better.

What are the main aims of this study?

The study aims to see if certain steroid medications can prevent the cancer from coming back in the brain, and if more intense treatment helps high-risk patients.

What kind of medicines are involved?

The treatment involves a combination of different chemotherapy drugs. Your doctors will give you a full list and explain what each one does.

Who is paying for this study?

This is an international cooperative study involving various medical groups and institutions across different countries.

How to find out more

Birgit Burkhardt, Prof. Dr. Dr.

lbl2018@ukmuenster.de +49 251 83 55696 Official trial record

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