RecruitingPHASE2INTERVENTIONAL

International Study for Treatment of High Risk Childhood Relapsed ALL 2010

This international study is for children and adolescents whose acute lymphoblastic leukemia (ALL) has returned. Even though treatments for childhood ALL have improved, it remains a serious condition if it comes back, especially for those in the high-risk group. This study aims to find better ways to treat these high-risk cases. Researchers are looking into whether adding a new drug called Bortezomib to existing treatments can improve the chances of the cancer going into a second remission (a period where the cancer is not detectable in the body). The study will involve a randomised comparison, meaning some patients will receive the new drug alongside standard therapy, while others receive standard therapy. All participants will eventually move on to a stem cell transplant if their condition allows.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Charite University, Berlin, Germany

Enrolment target

250

Start

01 Sep 2017

Estimated completion

31 Dec 2027

Acute Lymphoblastic Leukemia (ALL)

What is this study about?

When children and teenagers are diagnosed with acute lymphoblastic leukemia (ALL), doctors work hard to treat it. While many get better, sometimes the cancer comes back. When this happens, it's called a relapse. If the relapse is considered 'high-risk', it means it's more challenging to treat, and doctors are always looking for better options to improve the chances of a successful outcome.

This study, called IntReALL HR 2010, focuses specifically on these high-risk cases of relapsed ALL. Researchers are trying to improve the current treatments by adding a new medication called Bortezomib. Bortezomib is a drug that works by blocking certain processes within cancer cells, which can help stop them from growing and dividing. It has shown promise when used alongside other cancer drugs in previous studies.

The main goal of this study is to see if adding Bortezomib to the established treatment plan can help more children and teenagers achieve a second remission, meaning the cancer becomes undetectable. This is an important step towards a longer-term cure. After this initial treatment phase, all participants who are doing well will typically receive a stem cell transplant, which is a common and important step in treating high-risk relapsed ALL.

Key takeaways

This study is for children and teenagers with high-risk relapsed ALL.
It aims to find better treatments using a new drug called Bortezomib.
Participants will receive standard treatment, possibly with Bortezomib.
The goal is to improve the chance of the cancer going into remission again.
All suitable participants will eventually have a stem cell transplant.
Close monitoring for effects and side effects will be part of the care.

Who may be eligible?

To join this study, children and teenagers must have been diagnosed with their first relapse of a specific type of ALL (B-cell or T-cell precursor ALL). They need to be under 18 years old when they start the study and meet specific 'high-risk' criteria, which doctors will determine based on how soon the cancer returned and where it reappeared in the body.

There are also some important reasons why someone might not be able to join. For example, if their ALL has a particular genetic change called BCR-ABL or t(9;22), or if they have already had a stem cell transplant. For teenagers, pregnancy or breastfeeding would also prevent participation, as would not being willing to use effective contraception if sexually active until a year after treatment ends. It's also vital that participants and their families are willing and able to follow all the study procedures.

Ultimately, the decision to join is a personal one. If a patient or their legal guardian doesn't want to follow the whole study plan, or if a minor patient who can understand objects, they wouldn't be able to participate. Doctors will also check for any other serious health conditions that might make it unsafe to follow the study's treatment plan.

Quick self-check

Is my child under 18 years old?
Has their ALL relapsed for the first time?
Is their ALL classified as 'high-risk' by their doctors?
Are we willing to follow a specific treatment plan and attend regular appointments?
Has my child NOT had a stem cell transplant before this relapse?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

Taking part in this study would involve a specific treatment plan for your child's high-risk relapsed ALL. This includes receiving an experimental drug called Bortezomib alongside standard chemotherapy medications. Patients will be randomly assigned to groups, meaning they will either receive Bortezomib plus standard treatment, or standard treatment alone, to compare their effectiveness.

The treatment will start with an 'induction' phase, aiming to get the cancer into remission, which is then followed by intensive 'consolidation' treatment. Throughout this time, there will be regular visits to the hospital for assessments, blood tests, and to monitor how your child is responding to treatment and to check for any side effects. After the main treatment phases of the study are complete, all patients who have responded well would typically move on to a stem cell transplant, which is a standard part of treating high-risk relapsed ALL. The total duration of the study treatment phases and follow-up would be discussed in detail by the medical team.

Potential risks and benefits

Participating in this study might offer the potential benefit of a new, more effective treatment option for high-risk relapsed ALL, especially if the Bortezomib combination proves more successful than standard therapy. However, like all cancer treatments, there are potential risks, including side effects from the medications. The medical team will closely monitor your child for any adverse effects and manage them as best as possible. It is important to know that you are free to withdraw your child from the study at any time, for any reason, without affecting their future medical care.

Locations (15)

Australian & New Zealand Childhood Hematology & Oncology Group
Clayton, Australia· Recruiting
St. Anna Kinderkrebsforschung, CCRI
Vienna, Austria· Recruiting
Hòpital Universitaire des Enfants Reine Fabiola
Brussels, Belgium· Recruiting
University Hospital Motol
Prague, Czechia· Recruiting
Copenhagen University Hospital (Rigshospitalet)
Copenhagen, Denmark· Not yet recruiting
Turku University Central Hospital
Turku, Finland· Recruiting
CHU Nice
Nice, France· Recruiting
Tel Aviv Sourasky Medical Centre
Tel Aviv, Israel· Recruiting
Ospedale Pediatrico Bambino Gesù
Roma, Italy· Recruiting
Prinses Máxima Centrum, Lundlaan
Utrecht, Netherlands· Recruiting
Oslo University Hospital
Oslo, Norway· Not yet recruiting
Dpt. SCT and Hematology/Oncology University Wroclaw
Wroclaw, Poland· Recruiting

+3 more sites — see the official record for the full list.

Common questions

What is ALL?

ALL stands for Acute Lymphoblastic Leukemia. It's a type of cancer that starts in the white blood cells in the bone marrow, which is the spongy tissue inside bones where blood cells are made.

What does 'relapsed' mean?

Relapsed means the cancer has come back after a period of being in remission (when the cancer cells were not detectable in the body).

What is Bortezomib?

Bortezomib is a medication that works by targeting specific processes within cancer cells to stop them from growing and multiplying. It's being investigated to see if it can improve ALL treatment outcomes.

What is a stem cell transplant?

A stem cell transplant replaces unhealthy blood-forming cells with healthy ones. It's a common and important treatment for high-risk relapsed ALL.

Can my child choose not to join the study?

Yes, joining a study is always voluntary. You and your child have the right to decide whether or not to participate, and this decision will not affect your child's medical care.

How to find out more

Arend von Stackelberg, MD

arend.stackelberg@charite.de +49(0)30-450666 Official trial record

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