HEM-iSMART subprotocol B (ALL/LBL)
Clinical study of dasatinib and venetoclax for children with relapsed or refractory leukemia or lymphoma with a mutation in the MAPK/SRC pathway.
Recruiting
Who can enter
Children with relapsed or refractory acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) with mutations in the MAPK/SRC pathway
1 to 21 years
Goal
Goal
The goal of this study is to investigate whether the combination of dasatinib and venetoclax is tolerable, safe and effective in combination with dexamethasone, cyclophosphamide and cytarabine. This is tested in patients who have had an inadequate response to previous treatment (refractory) or whose disease has come back (relapse).
Background
Background
Certain changes (mutations) present in leukemia or lymphoma cells are responsible for increased and uncontrolled cell growth. Known changes that act like this are mutations in several genes that are part of the MAPK-SRC signaling pathway.
Certain proteins control the growth of many cancers. These are the so-called tyrosine kinases, and the BCR-ABL and SRC family proteins are examples of tyrosine kinases. The drug dasatinib mainly inhibits the action of BCR-ABL proteins and proteins of the SRC family. This inhibits the division of cells and thus the growth of leukemia or lymphoma cells.
Venetoclax targets a particular enzyme that is increased in leukemia or lymphoma cells and prevents the cancer cells from dying naturally (this protein is called: BCL2 protein). Venetoclax turns off this BCL2 protein, causing the leukemia cells to die.
Dexamethasone, cyclophosphamide and cytarabine are drugs that can cause leukemia and lymphoma cells to die more quickly.
In order to participate in this study please contact your/your child’s treating physician.
For international patients: please feel welcome to contact our International Patients Office.
Last reviewed
Last reviewed
September 18, 2025
Study details
- Study details
Official title
International proof of concept therapeutic stratification trial of molecular anomalies in relapsed or refractory hematological malignancies in children. Sub-Protocol B: Dasatinib, venetoclax, dexamethasone, cyclophosphamide and cytarabine in pediatric patients with relapsed or refractory hematological malignancies.Cancer type
Acute lymphoblastic leukemia (ALL)
Lymphoblastic lymphoma (LBL)
Phase
1/2Maximum number of patients
26, of whom 3 are expected to participate in the NetherlandsStart date
September 18, 2025Status
OpenLocal principal investigator
Dr. Britta VormoorSponsor
Princess Máxima Center for pediatric oncologyApproval
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: 2022-501866-22-00
ClinialTrials.gov: NCT05751044
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.