Active not recruitingPHASE3INTERVENTIONAL

Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Children and Adolescents

This study is for children and young people recently diagnosed with acute lymphoblastic leukemia (ALL), the most common childhood cancer. While current treatments generally work well, this research aims to make them even better. Researchers are looking at new ways to decide how strong a child's treatment needs to be, using updated information about their leukemia. The goal is to give every child the best chance of a cure while trying to reduce side effects where possible. The study is also testing a new way of giving a chemotherapy drug called pegaspargase. By checking the drug's levels in the blood, doctors hope to adjust the dose more precisely, making the treatment both effective and safer for patients.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Dana-Farber Cancer Institute

Enrolment target

560

Start

03 Mar 2017

Estimated completion

01 Nov 2034

Acute Lymphoblastic Leukemia, Pediatric

What is this study about?

Acute lymphoblastic leukemia (ALL) is a type of cancer that affects the blood cells. It's the most common cancer in children and young people. In ALL, certain blood cells (called lymphocytes) grow abnormally in the bone marrow, which is the spongy material inside your bones where blood cells are made. These abnormal cells, called lymphoblasts, don't work properly to fight infections and can prevent healthy blood cells from being made. While ALL is very serious if not treated, thankfully, most children and young people can be cured with current treatments.

Standard treatment for ALL usually involves about two years of chemotherapy, which uses strong medicines to kill cancer cells. The exact treatment, including the specific drugs and their doses, can vary based on several factors. Doctors use 'risk factors' to help decide how strong the treatment should be to give each child the best chance of getting better. This study is exploring a new, updated set of these risk factors to make those decisions even more accurate. This could mean that some children might receive stronger treatment if their leukemia needs it, giving them a better chance of being cured. For others, it might mean they can receive a slightly less intense treatment if their leukemia is likely to respond well, helping to reduce potential side effects while still aiming for a cure.

Another important part of this study focuses on a specific chemotherapy drug called pegaspargase, which is a standard part of ALL treatment. While very effective, it can also cause side effects. Researchers want to see if they can give this drug more precisely. They will be measuring the level of pegaspargase in the blood and then adjusting the dose based on these levels. The hope is that by fine-tuning the dose, they can make sure the drug is working as well as it should be, while also reducing the chance of unwanted side effects.

Key takeaways

ALL is the most common childhood cancer, and most children are cured.
This study aims to make ALL treatment even better and safer.
Researchers are using updated information to personalise treatment strength.
A new way of giving the drug pegaspargase is being tested.
Participation involves standard-like ALL treatment with careful monitoring.
Your child can withdraw from the study at any time.

Who may be eligible?

To join this study, children and young people need to have been recently diagnosed with acute lymphoblastic leukemia (ALL).

There are also some other requirements. For instance, participants must be between one year old and just under 22 years old. They can't have had most other cancer treatments before joining, though some very short courses of specific medicines or emergency treatments might be allowed. The study will also check certain blood test results to make sure it's safe to take part.

There are also some reasons why someone might not be able to join. For example, if the leukemia is a very specific type of ALL (like Burkitt's ALL) or a rare type that mixes features of different leukemias, then this study might not be suitable. The parents or guardians must also be able to understand the study information and agree to their child taking part.

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.

Has your child been recently diagnosed with Acute Lymphoblastic Leukemia (ALL)?
Is your child between 1 year and 21 years old?
Has your child had very little or no previous cancer treatment?
Are you able to understand and agree to the study details?

Answer every question to see your result.

What does participation involve?

If your child takes part in this study, they will receive treatment for their ALL. The main difference will be that doctors will use new information, alongside standard information, to plan their treatment. They might also receive the chemotherapy drug pegaspargase in a new way, where the dose is adjusted based on blood tests.

Throughout the study, your child will have regular check-ups, blood tests, and other assessments, just like they would during standard ALL treatment. These visits will help doctors monitor their health, how they are responding to treatment, and any side effects. The total treatment period for ALL usually lasts about two years. Following treatment, there will be ongoing follow-up appointments to monitor your child's health and ensure the leukemia doesn't return.

Potential risks and benefits

Participating in this study might offer some potential benefits, as the new approaches could lead to more effective treatment with fewer side effects for some children. However, there are no guarantees, and children may experience similar risks and side effects to standard chemotherapy treatments, which can be significant. The new way of dosing pegaspargase is being tested to see if side effects can be reduced, but this isn't certain. You will be given detailed information about all potential risks and benefits. Please remember that taking part is entirely voluntary, and you have the right to withdraw your child from the study at any time without it affecting their future medical care.

Locations (9)

Boston Children's Hospital
Verified postcode
Boston, United States
Dana-Farber Cancer Institute
Verified postcode
Boston, United States
Rutgers Cancer Institute of New Jersey
Verified postcode
New Brunswick, United States
Roswell Park Cancer Institute
Verified postcode
Buffalo, United States
Columbia University Medical Center, Morgan Stanley Children's Hospital of New York-Presbyterian
Verified postcode
New York, United States
Montefiore Medical Center
Verified postcode
The Bronx, United States
Hasbro Children's Hospital / Rhode Island Hospital
Verified postcode
Providence, United States
Hospital Sainte Justine, University of Montreal
Verified postcode
Montreal, Canada
Centre Hospitalier U. de Quebec
Verified postcode
Québec, Canada

Common questions

What is Acute Lymphoblastic Leukemia (ALL)?

ALL is a type of cancer that affects the white blood cells. It's the most common cancer diagnosed in children.

What is chemotherapy?

Chemotherapy uses strong medicines to kill cancer cells throughout the body. It's a key part of ALL treatment.

Why are you looking at new 'risk factors'?

We're looking at new factors to help doctors better decide how strong each child's ALL treatment needs to be, aiming for the best chance of cure with the fewest possible side effects.

What is pegaspargase?

Pegaspargase is a chemotherapy drug commonly used to treat ALL. This study is testing if adjusting its dose based on blood levels can make it safer and just as effective.

How long does treatment usually last?

Standard treatment for ALL, including in this study, typically lasts about two years.