HEM-iSMART
HEM-iSMART: International clinical trial for children and adolescents with relapsed or refractory leukemia or lymphoma with specific mutations
HEM-iSMART is a study aimed at providing personalized treatment for relapsed (recurring) or refractory (treatment-resistant) acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL). Through molecular analysis of the genetic characteristics of the leukemia or lymphoma, a suitable, targeted treatment option is initiated. These medications are specifically tailored to the genetic characteristics of the leukemia or lymphoma.
The goal of the HEM-iSMART study is to use various new therapies tailored to the specific genetic alterations in the patient’s disease.
Patients who meet the criteria for participation in the study will be assigned to one of the subprotocols based on the results of the molecular analysis.
Currently open Subprotocols:
Subprotocol B: For patients with leukemia or lymphoma with alterations in the MAPK/SRC signaling pathway (mutations in the ABL, SRC, and/or PDGFβ kinases). Treatment consists of the targeted drugs dasatinib and venetoclax (taken orally once daily; can be taken at home), as well as the conventional chemotherapy drugs dexamethasone, cyclophosphamide, and cytarabine (administered intravenously in the hospital).
Subprotocol C: For patients with leukemia or lymphoma involving alterations in the IL7R/JAK-STAT signaling pathway. Treatment consists of the targeted drugs ruxolitinib and venetoclax (oral, daily, can be taken at home), as well as the conventional chemotherapeutic agents dexamethasone, cyclophosphamide, and cytarabine (administered intravenously in the hospital).
Subprotocol D: For patients with leukemia or lymphoma involving a mutation in the RAS signaling pathway (RAS mutation). Treatment consists of the targeted drug trametinib (taken orally, daily; can be taken at home), as well as the conventional chemotherapy drugs dexamethasone, cyclophosphamide, and cytarabine (administered intravenously in the hospital).
Additional subprotocols will follow.
Is this study suitable for my child’s condition?
Leukaemia, lymphoma and bone marrow disease
- Acute lymphoblastic leukemia (ALL)
- Acute myeloid leukemia (AML)
- Chronic myeloid leukemia (CML)
- Myelodysplastic syndrome (MDS)
- Severe aplastic anemia (SAA)
- Non-Hodgkin lymphoma
- Hodgkin lymphoma
- Other leukaemia, lymphoma and bone marrow disease
Brain and spinal cord tumors
- Low-grade glioma
- High-grade glioma
- Diffuse-intrinsic pontine glioma (DIPG) / Diffuse midline glioma (DMG)
- Medulloblastoma
- Atypical teratoid rhabdoid tumours (ATRT)
- Ependymoma
- Germ cell tumours / germinoma / nongerminomatous germ cell tumours / teratoma (brain / spinal cord)
- Craniopharyngioma
- Other brain tumours or spinal cord tumours
Solid tumors
- Wilms tumours / nephroblastoma
- Neuroblastoma
- Rhabdomyosarcoma
- Ewing sarcoma
- Osteosarcoma
- Rhabdoid tumours (other than brain or spinal cord)
- Other sarcoma
- Germ cell tumours (other than brain or spinal cord)
- Retinoblastoma
- Hepatoblastoma
- Other solid tumours
Study Information
What age range of children can participate?
Up to 21 years
Official Study Information
Study at www.humanforschung-schweiz.ch
Study at www.clinicaltrials.gov
Questions? Please contact your medical team.
If you would like more information about a study, please speak to your child’s treating physician. They are your primary point of contact and can provide personalized advice and support. If no treatment team is currently in place, you can find general contact information for the study sites on the map below.
Treatment Centers with Open Study – Map & Overview
The map shows all treatment sites in Switzerland. Locations where the study is currently open are marked in blue. You can find contact details by clicking on the towns. The information on study sites is updated regularly. However, a study may occasionally open at a new site before this is reflected on the platform. If in doubt, please contact your treatment team or one of the listed clinics directly.
Zürich
Universitäts-Kinderspital Zürich –
Eleonorenstiftung
Lenggstrasse 30
8008 Zürich
https://www.kispi.uzh.ch
Sekretariat Onkologie
Telefon: +41 44 249 63 50
E-Mail: onkologie.sekretariat@kispi.uzh.ch