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New treatment option for Acute Lymphoblastic Leukemia
Official title Use of Levocarnitine to Reduce Asparaginase Hepatotoxicity in Patients With Acute Lymphoblastic Leukemia
ClinicalTrials.gov ID: NCT05501899
What this study is testing
What is Levocarnitine?
Levocarnitine is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for acute lymphoblastic leukemia.
Also referred to as Carnitor®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 29
You may be able to join if
- 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 to the levocarnitine regimen
You likely can't join if
- Known allergic reaction to levocarnitine or its components
- Presence of severely compromised renal function or end-stage renal disease
- Pregnancy or lactation
- Warfarin therapy
- History of seizures prior to ALL diagnosis
- Known inborn error of metabolism
The study team makes the final eligibility decision.
Where it's taking place
- Orange, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 5 years to 29 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orange, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.