Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Early Phase 1 study of Acute Lymphoblastic Leukemia and Hepatotoxicity, sponsored by Children's Hospital of Orange County.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What NCT05501899 shows while recruiting
NCT05501899 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 382-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (95% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Acute Lymphoblastic Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05501899's enrollment target sits among peer trials
20 103rd of 131 higher than 24 of 131 other Acute Lymphoblastic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Lymphoblastic Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Multi-modality Imaging and Collection of Biospecimen Samples in Understanding Bone Marrow Changes in Patients With Acute Myeloid Leukemia Undergoing TBI and Chemotherapy
RECRUITING · Early Phase 1
-
Allogeneic CMV-Specific CD19-CAR T Cells Plus CMV-MVA Triplex Vaccine After Matched Related Donor Hematopoietic Cell Transplant for the Treatment of Patients With High-Risk Acute Lymphoblastic Leukemia
RECRUITING · Early Phase 1
-
A Study of Venetoclax in Combination With Chemotherapy to Treat Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)
ACTIVE NOT RECRUITING · Early Phase 1
-
A Pilot Study to Determine the Safety and Tolerability of Sirolimus Given With Hyper-CVAD Chemotherapy
COMPLETED · Early Phase 1
-
InterNatIonal CHildhood Leukemia Microbiome/MEtabolome Cohort
RECRUITING
-
The Pediatric Acute Leukemia (PedAL) Screening Trial - A Study to Test Bone Marrow and Blood in Children With Leukemia That Has Come Back After Treatment or Is Difficult to Treat - A Leukemia & Lymphoma Society and Children's Oncology Group Study
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00573339 · 20 participants
Cardiac Magnetic Resonance Imaging (MRI) Normal Reference Control Group Testing
- NCT00692939 · 20 participants · Phase 1
Autologous Stem Cell Transplantation for Crohn's Disease
- NCT00967785 · 20 participants · Phase 1
A Phase I Study of Mozobil in the Treatment of Patients With WHIMS
- NCT01406691 · 20 participants · Phase 4
Light Flashes to Treat Delayed Sleep Phase Disorder (DSPD)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI