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Closed (no longer recruiting)Last updated: 17 May 2024

TOTAL17: This phase II/III trial is trying to understand how effective using a combination of cancer treatments (including chemotherapy, targeted therapy and immunotherapy) to target specific genes is when treating children with acute lymphoblastic leukaemia (ALL) and acute lymphoblastic lymphoma (LLy)Total Therapy XVII for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia and Lymphoma

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 patients with acute lymphoblastic leukaemia and acute lymphoblastic lymphoma

Cancer

Blood Cancers Haematological

Age

People1 - 18

Phase

II/III

Trial Acronym

TOTAL17

More information

Trial Identifiers

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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

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.
  • 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.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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