Levocarnitine for Liver Toxicity in Acute Lymphoblastic Leukemia

Recruiting at 1 trial location

Overseen By Van T. Huynh, M.D.

Age: < 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: Children's Hospital of Orange County

Must be taking: Levocarnitine

Must not be taking: Warfarin

Disqualifiers: Severe renal disease, Pregnancy, Seizures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether levocarnitine, a supplement form of a naturally occurring compound in the body, can reduce liver damage from certain chemotherapy drugs in people with acute lymphoblastic leukemia (ALL). The focus is on newly diagnosed high-risk ALL patients, as their treatment often includes drugs that heavily impact the liver. Researchers will administer levocarnitine during the initial treatment phases to determine if it lowers the risk of liver issues. This trial may suit individuals aged 5 to under 30 who are newly diagnosed with high-risk ALL and can take oral medications. As an Early Phase 1 trial, this research aims to understand how levocarnitine works in people, offering participants a chance to be among the first to receive this treatment.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on warfarin therapy. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that levocarnitine is likely to be safe for humans?

Research has shown that levocarnitine is generally safe for people. One study found that levocarnitine might help reduce liver damage by improving liver enzyme levels in patients treated for acute lymphoblastic leukemia (ALL). This suggests it is well-tolerated and could lessen liver-related side effects from chemotherapy.

Levocarnitine is already used as a supplement for those lacking carnitine, providing confidence in its safety. It is not a new substance and has been used for other health issues. Although this trial is in its early stages, levocarnitine's use in various health situations supports its potential safety for patients with ALL. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Levocarnitine is unique because it targets liver toxicity in patients with acute lymphoblastic leukemia by focusing on a new mechanism: enhancing the metabolism of fatty acids to protect liver cells. Most treatments for this condition, like chemotherapy, can inadvertently harm the liver, leading to serious side effects. Unlike these standard treatments, levocarnitine leverages its role as a natural compound in the body to potentially reduce liver damage, offering a gentler approach. Researchers are excited about levocarnitine because it could complement existing therapies by safeguarding liver health, potentially improving overall treatment outcomes and quality of life for patients.

What evidence suggests that levocarnitine might be an effective treatment for liver toxicity in acute lymphoblastic leukemia?

Research has shown that levocarnitine, which participants in this trial will receive, might help protect the liver during cancer treatment. One study found that taking levocarnitine for 60 days improved liver enzyme levels, suggesting it can help prevent liver damage. This is important because asparaginase, a drug used to treat acute lymphoblastic leukemia (ALL), can harm the liver. Levocarnitine may be beneficial because it reduces cell damage and inflammation. Early studies are promising, indicating that levocarnitine might lower the risk of serious liver injury in patients receiving chemotherapy. These findings suggest levocarnitine could effectively reduce liver problems in patients treated for ALL. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for patients aged 5 to under 30 years who have been newly diagnosed with high-risk Acute Lymphoblastic Leukemia (ALL) and are following a Children's Oncology Group treatment protocol. They must be able to take oral medication and follow the levocarnitine regimen. Excluded are those allergic to levocarnitine, on warfarin therapy, with metabolic disorders, severe kidney issues, pregnant or lactating women, or with a history of seizures before ALL diagnosis.

Inclusion Criteria

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)

Patients aged 5 to < 30 years

Exclusion Criteria

Presence of severely compromised renal function or end-stage renal disease

Pregnancy or lactation

You have had seizures before being diagnosed with ALL (acute lymphoblastic leukemia).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction

Participants receive levocarnitine supplementation during the Induction phase of chemotherapy to reduce hepatotoxicity

6-8 weeks

Regular visits as per COG treatment protocol

Consolidation

Continuation of levocarnitine supplementation during the Consolidation phase of chemotherapy

4-6 weeks

Regular visits as per COG treatment protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

1.5 years

What Are the Treatments Tested in This Trial?

Interventions

• Levocarnitine

Trial Overview The study tests if Levocarnitine can reduce liver toxicity in pediatric and young adult patients undergoing chemotherapy for ALL. Participants will receive oral Levocarnitine during initial treatment phases where hepatotoxic agents like asparaginase are most commonly used.

How Is the Trial Designed?

Group I: Treatment Arm (single arm) Experimental Treatment 1 Intervention

Levocarnitine is already approved in United States, European Union for the following indications:

Approved in United States as Carnitor for:

• Carnitine deficiency
• Hyperlipoproteinemia

Approved in European Union as Levocarnitine for:

• Carnitine deficiency
• Hyperlipoproteinemia

Who Is Running the Clinical Trial?

Children's Hospital of Orange County

Lead Sponsor

Trials

38

Recruited

5,700+

University of California, Irvine

Collaborator

Trials

580

Recruited

4,943,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11782257/

Effects of oral Lcarnitine supplementation on liver enzymes in ... The results of this study suggested that a 60-day Lcarnitine treatment can improve liver enzyme levels and thus prevent the extent of liver damage during the ...

2. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-03148

Levocarnitine to Reduce Hepatotoxicity in Patients with ... This early phase I trial tests the safety, side effects, and effectiveness of levocarnitine given during induction and consolidation therapy for patients ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05501899?cond=Hepatotoxicity&viewType=Table&rank=5

Use of Levocarnitine to Reduce Asparaginase ... 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 ...

4. cincinnatichildrens.org cincinnatichildrens.org/service/c/clinical-trials/studies/ACCL1931-031125

Studying the Effect of Levocarnitine in Protecting the Liver ... The overall goal of this study is to determine whether adding levocarnitine to standard of care chemotherapy will reduce the chance of developing severe liver ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10183102/

Levocarnitine for asparaginase-induced hepatic injury Asparaginase, an important treatment component for acute lymphoblastic leukemia (ALL), causes severe hepatotoxicity in some patients.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8559504/

Levocarnitine for pegaspargase‐induced hepatotoxicity in ... Levocarnitine supplementation may reduce the risk for hepatoxicity during induction therapy for acute lymphoblastic leukemia. graphic file with ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05602194

NCT05602194 | Studying the Effect of Levocarnitine in ... The overall goal of this study is to determine whether adding levocarnitine to standard of care chemotherapy will reduce the chance of developing severe liver ...