CASSIOPEIA (B-ALL)
Active, not recruiting
Who can enter
Children and adolescents with B-cell acute lymphoblastic leukemia (B-ALL) with a high risk of recurrence
Age: 1 up to 25 years
Goal
Goal
The goal of this study is to find out how safe and effective the new tisagenlecleucel treatment is for children and adolescents aged 1 up to 25 years with a high-risk B-ALL.
Background
Background
Children and adolescents who are diagnosed with B-ALL are treated according to the ALLTogether or ALL-11 treatment protocol. At the end of the first blocks of chemotherapy, sometimes minimal residual disease is still present (i.e., some leukemic cells can still be detected in the bone marrow). These children have a high risk of recurrence. In this study we test a new way of treating children with high-risk B-ALL: using CAR T-cells (a form of immunotherapy).
To do so, T cells (certain white blood cells) will first be collected from the child's blood. This process is called apheresis. The genetic characteristics of these T-cells are then changed in the laboratory so that they can recognize and destroy the leukemic cells. The genetically altered cells, called CAR T-cells, are returned to the child via an infusion. CAR T cells from the Novartis company are called tisagenlecleucel.
Tisagenlecleucel has been approved (“registered”) by the Dutch authorities as a drug for the treatment of advanced B-ALL in children and adolescents up to 25 years old and for a certain type of lymphoma in adults. When the medication is given to children for whom no other treatment options are available, more than 80 percent enter remission and approximately 65 percent of the children are still free of leukemia after two years. In children with an earlier stage of the disease doctors are not yet allowed to prescribe this medication. That is why this study is needed.
This study is now closed for inclusion.
Last reviewed
Last reviewed
March 20, 2026
Study details
- Study details
Official title
Phase II study with tisagenlecleucel in first-line patients (children and adolescents) with high-risk B-cell acute lymphoblastic leukemia who have a minimal residual disease at the end of the consolidation treatment (CASSIOPEIA)Cancer type
B-ALLPhase
2Maximum number of patients
160, of whom 4 are expected to participate in the NetherlandsStart date
June 14, 2019Status
Closed for inclusionLocal principal investigator
Prof. dr. R. PietersSponsor
Novartis Pharma BVApproval
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 Register EUDRACT number 2017-002116-14
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.