Total Therapy XVII for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia and Lymphoma

Launched by ST. JUDE CHILDREN'S RESEARCH HOSPITAL · Apr 12, 2017

Keywords

ClinConnect Summary

This clinical trial, called Total Therapy XVII, is designed to find better ways to treat children diagnosed with acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LLy). The goal is to improve the chances of survival and enhance the quality of life for these young patients by using advanced treatment strategies tailored to the specific genetic features of their leukemia. The trial will look at various therapies, including targeted medications and immunotherapy, to see how they can help children respond better to treatment and reduce side effects.

To participate in this trial, children ages 1 to 18 must have a confirmed diagnosis of either B-ALL, T-ALL, or LLy, and they should not have received extensive prior treatment. Participants can expect to receive innovative care that includes close monitoring and support throughout their treatment journey. This study is currently active but not recruiting new participants. It aims to gather important information that could help shape future therapies for these conditions, ultimately striving for better outcomes for children with leukemia and lymphoma.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * 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 Criteria:
• • 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.