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Levocarnitine for Chemotherapy-Related Liver Protection in Leukemia and Lymphoma

Phase 3
Recruiting
Led By Etan Orgel
Research Sponsored by Children's Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Summary

This trial will test if adding levocarnitine to chemo helps protect the liver in leukemia/lymphoma patients.

Who is the study for?
This trial is for young adults aged 15-39 with newly diagnosed B-ALL, T-ALL, lymphoblastic lymphoma, or MPAL. They must have liver function within certain limits and plan to receive asparaginase chemotherapy. Excluded are those with Down syndrome, inherited/autoimmune liver diseases, severe liver fibrosis, prior malignancy treatments (except specific allowed cases), pregnant or breastfeeding women, and those not using effective contraception.Check my eligibility
What is being tested?
The study tests if Levocarnitine added to standard chemotherapy can protect the liver from damage caused by asparaginase in leukemia/lymphoma patients. It compares outcomes of patients receiving Levocarnitine plus chemotherapy against those receiving only standard chemo.See study design
What are the potential side effects?
Levocarnitine may cause nausea, vomiting, abdominal cramps, diarrhea and a 'fishy' body odor. As it's being used alongside chemotherapy drugs like pegaspargase which can cause liver issues among other side effects; monitoring will be crucial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of conjugated hyperbilirubinemia >3 mg/dL during induction therapy
Secondary outcome measures
Alanine Transaminase
Incidence of minimal residual disease (MRD) positivity (MRD >= 0.01%)
Other outcome measures
Adherence to oral levocarnitine during induction chemotherapy measured by percentage of pills returned relative to those prescribed
Levocarnitine
Asparaginase activity
+14 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Arm C (rescue levocarnitine)Experimental Treatment1 Intervention
Patients in Arms A and B who develop conjugated hyperbilirubinemia > 3 mg/dL during induction may receive levocarnitine rescue PO or IV supplementation until resolution of conjugated hyperbilirubinemia =< 3 mg/dL (or start of consolidation or the next treatment phase, whichever occurs first).
Group II: Arm A (levocarnitine, standard of care chemotherapy)Experimental Treatment5 Interventions
Patients receive levocarnitine PO or IV prior to standard of care induction chemotherapy with pegaspargase or calaspargase pegol on study. Patients may also undergo blood sample collection during screening and on study.
Group III: Arm B (standard of care chemotherapy)Active Control4 Interventions
Patients receive standard of care induction chemotherapy with pegaspargase or calaspargase pegol on study. Patients may also undergo blood sample collection during screening and on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1720
Levocarnitine
1996
Completed Phase 3
~510
Pegaspargase
2005
Completed Phase 3
~9010

Find a Location

Who is running the clinical trial?

Children's Oncology GroupLead Sponsor
456 Previous Clinical Trials
239,347 Total Patients Enrolled
Etan OrgelPrincipal InvestigatorChildren's Oncology Group
~293 spots leftby Dec 2027