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NCT05501899 · ClinicalTrials.gov registry record · Early Phase 1
Use of Levocarnitine to Reduce Asparaginase Hepatotoxicity in Patients With Acute Lymphoblastic Leukemia
A Early Phase 1 study of Acute Lymphoblastic Leukemia and Hepatotoxicity, sponsored by Children's Hospital of Orange County.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 20
- Enrollment target
- 2
- Study locations
NCT05501899 is a Early Phase 1 study of Acute Lymphoblastic Leukemia and Hepatotoxicity that is actively recruiting participants, run by Children's Hospital of Orange County. The registered enrollment target is 20 participants, below the 382-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (95% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT05501899, a Early Phase 1 study of Acute Lymphoblastic Leukemia and Hepatotoxicity, is actively recruiting participants, sponsored by Children's Hospital of Orange County.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 20 participants
- Enrollment target
- 2
- Study locations
Study Summary
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. The frequency of TAH is increased in overweight or obese patients of Latino heritage. Carnitine is a naturally-derived compound that is produced in the liver and kidneys; it is found in certain foods, such as meat, poultry, fish, and some dairy products. Endogenous carnitine transports long-chain fatty acids into the mitochondria, where they are oxidized to produce energy, and acts as scavengers of oxygen free radicals. Thus, carnitine can reduce oxidative stress and modulate inflammatory response. Levocarnitine is a supplement form of carnitine used typically in the care and management of patients with carnitine deficiency. Pediatric and AYAs with ALL will be given oral levocarnitine as a supplement during their initial phases of treatment, when the most hepatotoxic agents are administered, to determine if the incidence of liver toxicity can be reduced or eliminated.
Conditions Studied
Interventions
- DRUG Levocarnitine
Study Locations (2)
California
- Chao Family Comprehensive Cancer Center, University of California, Irvine - Orange
- Children's Hospital of Orange County - Orange
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-03-03 |
| Est. Completion | 2024-12-31 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05501899
The ClinicalTrials.gov registry entry for NCT05501899 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 382-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (95% lower). The listed sponsor is Children's Hospital of Orange County, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 1 intervention - of which Levocarnitine is the first listed.
NCT05501899 reports 2 study locations spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT05501899 about?
NCT05501899 is a clinical study titled "Use of Levocarnitine to Reduce Asparaginase Hepatotoxicity in Patients With Acute Lymphoblastic Leukemia". 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 i...
What is the current status of trial NCT05501899?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2023-03-03. Estimated completion is 2024-12-31.
What conditions does trial NCT05501899 study?
This clinical trial studies the following conditions: Acute Lymphoblastic Leukemia, Hepatotoxicity.
What interventions are being tested in trial NCT05501899?
The interventions under investigation include: Levocarnitine (DRUG).
Who is sponsoring clinical trial NCT05501899?
This trial is sponsored by Children's Hospital of Orange County, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05501899 being conducted?
This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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