ITCC-101/APAL
A study of fludarabine/cytarabine/gemtuzumab ozogamicin with or without venetoclax in children with recurrent acute myeloid leukaemia
Existing data from adults with recurrent acute myeloid leukemia (AML) suggest that venetoclax in combination with other agents increases response rates and patient survival. However, since AML is a more aggressive disease with a high growth rate in children, and children can generally tolerate more aggressive therapies, venetoclax is being tested in combination with high-dose chemotherapy in the clinical trial. The dosage is adjusted according to body size (and age in children under 2 years of age) and venetoclax is taken for 28 days. After the screening phase to determine whether patients are eligible for treatment, two cycles of chemotherapy are administered, with cycle 1 consisting of nine visits and cycle 2 consisting of six visits to the trial center. Treatment with two cycles lasts a total of approximately 10-12 weeks. The duration of the post-treatment phase varies depending on the patient. After starting treatment, patients are monitored for a further 5 years. For this study, patients are randomly assigned to receive treatment with or without venetoclax. The investigator and study staff have no influence on the outcome of the randomization. The probability of receiving venetoclax is 1:2.
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