Trial purpose
Cancer treatment
Tumor type
Haematological
Age
1 - 18
Clinical summary
Summary
Participants will be classified into one of three categories (low-, standard-, or high-risk) based on a range of factors including diagnosis. Treatment will consist of three main phases: Remission Induction, Consolidation, and Continuation. There may be other phases included depending on the individual's diagnoses and risk. Some treatments will be administered orally, others will be administered intravenously (IV) or intramuscularly (IM), and others will be administered via subcutaneous injection (SQ).
Conditions
This trial is treating people with acute lymphoblastic leukaemia and acute lymphoblastic lymphoma
Eligibility
Inclusion
- Diagnosis of B- or T-ALL or LLy by immunophenotyping:
- LLy participants must have < 25% tumor cells in bone marrow and peripheral blood by morphology and flow cytometry. If any of these show ≥25% blasts, patient will be considered to have leukemia. Patients with MPAL are eligible.
- Age 1-18 years (inclusive).
- No prior therapy, or limited prior therapy, including systemic glucocorticoids for one week or less, one dose of vincristine, emergency radiation therapy (e.g., to the mediastinum, head and neck, orbit, etc.) and one dose of intrathecal chemotherapy.
- Written, informed consent and assent following Institutional Review Board (IRB), National Cancer Institute (NCI), Food and Drug Administration (FDA), and Office of Human Research Protections (OHRP) Guidelines.
Exclusion
- Participants who are pregnant or lactating. Males or females of reproductive potential must agree to use effective contraception for the duration of study participation.
- Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
Inclusion
- You have had treatment, but your cancer has come back (relapsed or recurrent).
- You have been diagnosed with cancer, but have not received any treatment.
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You are able to swallow medication by mouth.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Incyte Corporation,St Jude Children's Research Hospital
Scientific Title
Total Therapy XVII for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia and Lymphoma
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