Use of Levocarnitine to Reduce Asparaginase Hepatotoxicity in Patients With Acute Lymphoblastic Leukemia
Recruiting
Early Phase 1
Interventional Study
Acute Lymphoblastic Leukemia
Hepatotoxicity
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 5 – 29
- Sex
- Any
- Trial phase
- Early Phase 1
- Study type
- Interventional
- Purpose
- Supportive Care
- Participants needed
- 20 (estimated)
- Sponsor
- Children's Hospital of Orange County · Other
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About This Trial
Acute lymphoblastic leukemia (ALL) is the most common cancer seen in pediatric oncology. The necessary chemotherapy for pediatric and adolescent and young adult (AYA) patients with ALL includes steroids, anthracyclines, asparaginase, and vincristine. One of the most hepatotoxic chemotherapy agents is asparaginase, with treatment-associated hepatotoxicity (TAH) observed in up to 60% of patients. Th…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Patients aged 5 to \< 30 years
* Newly diagnosed with ALL designated as NCI high-risk (HR) ALL
* Treatment for ALL to be according to a Children's Oncology Group (COG) treatment protocol (on study or according to study)
* Ability to take oral medications and willing to adhere …
Contacts