HEM-iSMART: Evaluation of the activity of new drugs in T-ALL & T-LBL patients

A new trial, HEM-iSMART, has been launched in September 2025. This trial will investigate the safety and tolerability of the investigational agents and define the maximum tolerated dose and then evaluate the activity of new drugs in T-ALL (T-cell acute lymphoblastic leukemia)/T-LBL (T-cell lymphoblastic lymphoma) patients with specific alterations linked to mechanism of action of these drugs. Those types of cancer are caused by immature T cells called lymphoblasts.

The drug combination administered to the patient, expected to be more efficient on this type of cancer,  will depend on the specific molecular alteration found in the patient’s tumour. The patient will either receive:

-          Dasatinib + Venetoclax + Dexamethasone + Cyclophosphamide and Ara-C

-          Ruxolitinib + Venetoclax + Dexamethasone + Cyclophosphamide and Cytarabine

-          Trametinib + Dexamethasone + Cyclophosphamide and Cytarabine

Study will recruit patients younger than 18 year old at initial diagnosis, and less than 21 year old at enrolment. They will receive up to 2 cycles of treatment (each cycle being 28 days long, with an haematological recovery that may last until day 49).

Patients are evaluated at the end of each cycle and will only be allowed to enter cycle 2 if they achieve at least a partial response to the drug combination. A 3rd cycle could be given in case the patient shows a complete response at the end of cycle 2 and upon sponsor approval.

The international sponsor of the HEM-iSMART trial is the Princess Maxima Center for Pediatric Oncology of Utrecht (The Netherlands). In Belgium the study will open in UZ Gent hospital, with Pr. De Moerloose acting as the national coordinating investigator. For Belgium we expect to recruit 4 patients over a period of 6 years.