Go to Health Care Provider version
|Diagnosis||Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Neuroblastoma, Solid Tumors||Study Status||Open|
|Age||Child, Adult - (up to 30 Years)||Randomisation||YES|
|Line of treatment||Disease relapse or progression|
|Routes of Treatment Administration||Idasanutlin: oral
Note: Other drugs are given as usually administered for acute leukemia & solid tumor therapy|
|Last Posted Update||2021-08-31|
International SponsorHoffmann-La Roche
Principal Investigators for Canadian SitesAlberta Children's Hospital - Dr. Aru Narendran
Dr. Victor Lewis
Social worker/patient navigator contact
Clinical research contact
This study seeks to test the safety and effectiveness of the drug taken by mouth called idasanutlin when taken together with chemotherapy or other cancer drugs (venetoclax) to treat acute leukemias or solid tumors in pediatric or young adults.
The study is divided into 3 parts. The first part of the study aims to figure out the maximum dose of idasanutlin that can be safely tolerated as well as the recommended dose of idasanutlin when used in combination with chemotherapy and other cancer drugs (venetoclax).
The second part of the study aims to test the safety and effectiveness of idasanutlin in combination with chemotherapy and other cancer drugs (venetoclax) for treating neuroblastoma, acute myeloid leukemia (AML), and acute lymphoblastic leukemia (ALL).
The third part of the study further monitors patients for additional responses to idasanutlin and safety assessments.
- Age less than 18 years old or less than 30 years old depending on study groups
- Diagnosis of neuroblastoma, acute myeloid leukemia (AML), or acute lymphoblastic leukemia (ALL) that has worsened or come back despite the use of standard therapy.
- Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team