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Clinical trials
- Participate in a clinical trial
- For medical professionals
- Active clinical trials for pediatric cancers
- CAR-20/19-T cells in pediatric and young adult patients with relapsed/refractory B Cell Acute Lymphoblastic Leukemia (CAR-20/19-T) phase 1 clinical trial
- Unrelated and partially matched related donor peripheral stem cell transplantation for patients with hematologic malignancies clinical trial
- Early stage research
Active clinical trials
Cancer Clinical Trials - COG-ACCL1931
Protocol Summary
- Protocol No
- COG-ACCL1931
- Principal Investigator
- Michael Burke
- Phase
- III
- Title
- A Randomized Trial of Levocarnitine Prophylaxis to Prevent Asparaginase-Associated Hepatotoxicity in Adolescents and Young Adults Receiving Acute Lymphoblastic Leukemia Therapy
- Associated Disease(s)
-
Non-Hodgkin's Lymphoma
- Description (Summary)
- The overall goal of this study is to determine whether adding levocarnitine to standard of care ALL treatment will reduce the chances of developing severe liver damage from asparaginase chemotherapy.
Standard of care chemotherapy treatment for leukemia and lymphoma includes a type of chemotherapy named asparaginase, given either as the drug pegaspargase, or a similar drug, calaspargase pegol. This type of chemotherapy can cause severe liver damage. Some groups of people may also be at higher risk for liver damage due to the presence of fat in the liver even before starting chemotherapy. Patients who are of Japanese descent, Native Hawaiians, or are Hispanic or Latinx may be at greater risk for liver damage from chemotherapy for this reason. Similarly, patients with obesity are also at higher risk for liver damage from chemotherapy. This study looks at how well the drug levocarnitine works to prevent liver damage when given to adolescents and young adults being treated with asparaginase chemotherapy for their leukemia or lymphoma.
Levocarnitine is a drug used to provide extra carnitine, a naturally occurring nutrient that is part of a typical diet and is also made by your body. Carnitine is important to keep the liver healthy and may be able to prevent damage to the liver from chemotherapy and other drugs. Levocarnitine is well tolerated in adults receiving chemotherapy and when used to prevent liver damage for other diagnoses. Levocarnitine has also been approved by the Food and Drug Administration (FDA) as a safe and effective treatment in children for other diagnoses that affect the liver.
- Participating Institutions
- Childrens Hospital of Wisconsin
- ClinicalTrials.gov
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