Active not recruitingPHASE2INTERVENTIONAL

SC-PEG Asparaginase vs. Oncaspar in Pediatric Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma

This study is testing new approaches for children aged 1 to 21 with acute lymphoblastic leukaemia (ALL) and lymphoblastic lymphoma. We're comparing a new chemotherapy drug, SC-PEG, with a current one, Oncaspar, focusing on side effects and how long the drug stays in the body. We're also studying whether changing treatment based on tiny amounts of cancer cells (called 'minimal residual disease') can improve outcomes. Another part of the study looks at whether giving antibiotics early can prevent serious infections. We'll investigate if vitamin D levels affect bone problems during treatment and collect samples to learn more about these cancers to find better treatments in the future. The overall aim is to improve how we treat these illnesses.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Dana-Farber Cancer Institute

Enrolment target

240

Start

01 Jun 2012

Estimated completion

01 Jul 2027

Acute Lymphoblastic Leukemia Lymphoblastic Lymphoma

Results

Results from this study

Posted September 2022

Results have been published for this study.

Primary outcome

Number of Participants With Asparaginase-Related Toxicity

Asparaginase-related toxicity rate is defined as the percentage of patients who experience allergy (all grades), symptomatic pancreatitis (grade 2 or worse), thrombotic or bleeding complications requiring intervention (grade 2 or worse) with treatment attribution of possibly, probably or definite based on Common Terminology Criteria for Adverse Events (CTCAE) v4.

Full results on the registry

What is this study about?

This study is like a big research project to find better ways to treat childhood cancers called acute lymphoblastic leukaemia (ALL) and lymphoblastic lymphoma. These conditions need strong medicines, and we are always trying to make treatments safer and more effective for children and young people. This study specifically focuses on several important areas.

Firstly, we're looking at a new version of a common chemotherapy drug called asparaginase. The new version is called SC-PEG. We want to see how well it works and if it has similar side effects compared to another version called Oncaspar, which is already in use. We're also checking how long SC-PEG stays in the blood, as this could mean fewer injections. By comparing these drugs, we hope to find a version that causes fewer side effects or is easier to give. We're also looking at whether adjusting treatment based on very small amounts of remaining cancer cells (called minimal residual disease or MRD) might help improve the chances of a full recovery for children with ALL.

Secondly, the study is investigating ways to prevent common problems that can happen during cancer treatment. Many children getting chemotherapy are at risk of serious infections, so we're testing if giving antibiotics right from the start can stop these infections. We're also looking at how chemotherapy can affect bones, making them weaker. We want to understand if vitamin D, which helps bones stay strong, plays a role in preventing bone problems like broken bones. Finally, we'll be collecting samples to learn more about these cancers themselves, which could lead to even better treatments for children in the future.

Key takeaways

The study aims to improve treatment for childhood leukaemia and lymphoma.
It compares a new chemotherapy drug (SC-PEG) with an existing one (Oncaspar).
Researchers are exploring how to tailor treatment based on tiny amounts of remaining cancer cells.
The study also investigates ways to prevent serious infections and bone problems during treatment.
It is open to children and young people aged 1 to 21 years old.
Participation involves chemotherapy and regular medical checks over about two years.

Who may be eligible?

To join this study, a child or young person must have been recently diagnosed with acute lymphoblastic leukaemia (ALL) or lymphoblastic lymphoma. They should not have started any major treatment for their cancer yet, apart from some short courses of steroids, a single special injection, or emergency radiation for serious problems.

They cannot join the study if they've already had a lot of steroid treatment in the past month or two, or if they've received any chemotherapy or radiotherapy for a different cancer before. Also, children who have uncontrollable health problems, are pregnant or breastfeeding, or have certain other illnesses like HIV cannot take part. The study is open to both boys and girls aged between 1 year and 21 years old.

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.

Is your child between 1 and 21 years old?
Has your child been recently diagnosed with ALL or lymphoblastic lymphoma?
Has your child started little to no treatment for their cancer yet?
Does your child have any other serious health problems?
Has your child had chemotherapy or radiation for cancer before?
Is your child pregnant or breastfeeding (if applicable)?

Answer every question to see your result.

What does participation involve?

If you decide to take part, your child will receive anti-cancer medicines called chemotherapy. These will be given in different ways: some by mouth, some into a vein (like a drip), and some as injections into a muscle or directly into the fluid around the spine. The treatment schedule, including which drugs and how much, will depend on whether your child’s leukaemia is considered 'Standard Risk', 'High Risk', or 'Very High Risk', which is decided based on their age and other test results. The full course of treatment usually lasts for about two years.

Throughout the study, doctors will regularly check your child's progress. This involves taking blood, bone marrow, and spinal fluid samples to see how the treatment is working and to look for any side effects. They may also do scans like X-rays, CT scans, or MRI scans. The first part of the treatment, called 'steroid prophase', typically involves a hospital stay. You will have regular visits to the hospital for treatments and check-ups. You can withdraw from the study at any time.

Potential risks and benefits

Taking part in this study could offer carefully monitored treatment with potentially newer approaches that might improve outcomes for your child's leukaemia or lymphoma. There's a chance these new strategies, like tailored treatment based on minimal disease or early antibiotics, could reduce treatment complications or improve long-term recovery. However, like any medical treatment, there are potential risks and side effects associated with the chemotherapy drugs, which will be carefully explained by the medical team. There may also be unknown risks with new treatments like SC-PEG. You will receive very close medical care, and your child's health will be monitored throughout. You are free to withdraw your child from the study at any time, for any reason, without affecting their future medical care.

Locations (8)

Children's Hospital Boston
Verified postcode
Boston, United States
Dana-Farber Cancer Institute
Verified postcode
Boston, 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
New York, United States
Hasbro Children's Hospital
Verified postcode
Providence, United States
McMaster University
Verified postcode
Hamilton, Canada
Hospital Sainte Justine, University of Montreal
Verified postcode
Montreal, Canada
Centre Hospitalier U. de Quebec
Verified postcode
Québec, Canada

Common questions

What is leukaemia?

Leukaemia is a type of cancer that affects blood cells, specifically the white blood cells that fight infection. In leukaemia, these cells grow too quickly and don't work properly.

What is chemotherapy?

Chemotherapy is medicine used to kill cancer cells. It can be given in different ways, like by mouth, through a drip into a vein, or as injections.

What is 'minimal residual disease'?

This is a test that can find very tiny amounts of cancer cells that are too small to see under a microscope. Tracking these cells can help doctors decide if treatment needs to be adjusted.

Will my child definitely get the new drug SC-PEG?

The study is comparing SC-PEG with Oncaspar, which is currently used. Your child might receive either, but the doctors will discuss which treatment applies to your child's situation.

What happens if my child doesn't want to continue in the study?

You or your child can decide to leave the study at any time, for any reason. Their medical care will continue as usual, even if they leave the study.