ZUMA-4 (ALL/NHL)
Active, not recruiting
Who can enter
Children and adolescents with B-precursor acute lymphoblastic leukemia (ALL) or B-cell non-Hodgkin lymphoma (NHL) who did not or insufficiently respond to standard treatment (refractory), or in whom the disease has returned (relapsed)
Age ≤21 years (ALL) or <18 years (NHL)
Goal
Goal
The goal of this study is to determine whether CAR T cells (in this case KTE-X19 CAR T cells made by the company Kite Pharma), given to children after three days of chemotherapy, are safe and effective in the treatment of children with relapsed or refractory ALL or NHL.
Background
Background
The experimental treatment in this study is called KTE-X19.
KTE-X19, made by the company Kite Pharma, is a so-called CAR T-cell therapy (immunotherapy). T cells (a type of white blood cells) are filtered from the patient’s blood and are modified in the laboratory so that they can detect and destroy cancer cells. The modified cells are called ‘chimeric antigen receptor’ (CAR) T cells.
The CAR T cells are returned to the patient via infusion. They can now recognize the protein CD19 that is present on the surface of leukemia and lymphoma cells, and also on normal B cells.
The goal of the treatment with CAR T cells is to achieve remission. There is too little experience to tell whether treatment with CAR T cells alone is sufficient in the long run to cure the leukemia or lymphoma. Therefore, the need for further treatment (e.g. stem cell transplantation) will be examined.
This study is now closed for inclusion.
Last reviewed
March 23, 2026
Study details
- Study details
Official title
A Phase 1/2 Multi-Center Study Evaluating the Safety and Efficacy of KTE-X19 in Pediatric and Adolescent Subjects with Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (ZUMA-4).
Cancer typeB-precursor acute lymphoblastic leukemia (ALL)
B-cell non-Hodgkin lymphoma
Phase
1/2
Maximum number of patients
100 ALL and 16 NHL patients, of whom 1-5 are expected to participate in the Netherlands
Start date
1 februari 2016
Status
closed for inclusion
Local principal investigator
Prof. dr. R. Pieters
Sponsor
Kite Pharma, Inc.
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
ClinialTrials.gov NCT02625480
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.