EsPhALL 2022 (ALL)
Clinical study on the treatment of children with a Philadephia positive ALL
Recruiting
Who can enter
Children with Philadelphia-chromosome positive ALL or an ALL with an ABL class fusion
Age: between 1 and 18 years old
Goal
The aim of this study is to improve the treatment of children with Philadelphia-positive ALL or ALL with an ABL-class fusion gene. We want to investigate whether the use of immunotherapy (blinatumomab) added to chemotherapy causes ALL to recur in fewer children. We are also looking at the safety and side effects of this treatment.
Background
Patients with Philadelphia-positive ALL ('Ph+ ALL') or ALL with an ABL-class fusion gene are typically treated with chemotherapy in combination with medications called 'tyrosine kinase inhibitors'. Despite this combined treatment, we are still unable to cure all children with this specific form of ALL. Additionally, these treatments cause many side effects. Therefore, we are looking for better treatments and new medications.
Blinatumomab is a form of immunotherapy that causes the leukemia cells to die. Compared to chemotherapy, it usually causes fewer side effects and less severe side effects. We want to determine whether we can replace part of the chemotherapy with blinatumomab during treatment. With this, we aim to improve treatment outcomes and reduce side effects.
Blinatumomab is already approved for adults and children with different forms of ALL. It is also approved for the treatment of adults whose Ph+ ALL has relapsed. The combination of blinatumomab with a tyrosine kinase inhibitor, with or without chemotherapy, is effective in adults with Ph+ ALL or ALL with an ABL-class fusion gene.
In this study, we administer three courses of blinatumomab instead of intensive chemotherapy to participants. During a course, we administer blinatumomab continuously via an intravenous infusion for four weeks. After four weeks of treatment, there is one week of rest before the next course of blinatumomab or chemotherapy starts
In order to participate in a study please refer to your/your child’s doctor.
Last reviewed
May 19, 2026
Study details
- Study details
Official title
“AALL2131 / EsPhALL2022 - An International Pilot Study of Chemotherapy and Tyrosine Kinase Inhibitor with Blinatumomab in Patients with Newly-Diagnosed Philadelphia Chromosome-Positive or ABL-class Philadelphia Chromosome-Like B-cell Acute Lymphoblastic Leukemia”
Cancer type
ALL
Phase
3
Maximum number of participants
200, of whom 5 are expected to participate in the Netherlands
Start date
May 19, 2026
Status
Open
Local principal investigator
Dr. I.M. van der Sluis
Sponsor
University of Milano-Bicocca, Italy
Approval
The study of this new treatment has been reviewed by an accredited medical research ethics committee. This committee has decided that it is justified to ask patients to participate in this study. More information can be found at: CCMO.
Trial registry number
EU Clinical Trials (CTIS): 2025-520982-39-00
The above information is intended as a brief summary only and may not reflect the most up-to-date information. For full details and the current status of a protocol, physicians can contact the Princess Máxima Center directly.