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Studying the Effect of Levocarnitine in Protecting the Liver From Chemotherapy for Leukemia or Lymphoma

Testing if Levocarnitine helps protect liver during chemotherapy for blood cancers.

Recruiting
15-40 years
All
Phase 3

Levocarnitine Study for Liver Protection in Chemotherapy Patients

This study focuses on whether adding levocarnitine, a natural nutrient, can help shield the liver during chemotherapy for blood cancers like leukemia and lymphoma. Chemotherapy often uses a drug called asparaginase, which can harm the liver, especially in younger patients (ages 15-39) who might already have liver issues. Levocarnitine, a supplement providing extra carnitine, might lessen this liver damage.

Participants will be randomly divided into two groups. One group will receive levocarnitine alongside their regular chemotherapy, while the other will only receive standard chemotherapy. There’s also a rescue option to provide levocarnitine if severe liver damage occurs.

  • Study participation may last until the end of the chemotherapy induction phase, typically about 35 days.
  • Participants may need to visit the clinic for regular blood tests.
  • Levocarnitine is generally safe, but the study will monitor for any side effects.

Eligibility includes being 15 to 39 years old, having a recent diagnosis of specific blood cancers, and having no severe liver conditions. Participants must not be pregnant or breastfeeding and should agree to use birth control if applicable.

Study details
    B Acute Lymphoblastic Leukemia
    B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
    B Acute Lymphoblastic Leukemia
    BCR-ABL1-Like
    Lymphoblastic Lymphoma
    Mixed Phenotype Acute Leukemia
    T Acute Lymphoblastic Leukemia

NCT05602194

Children's Oncology Group

30 March 2025

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