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Levocarnitine for Chemotherapy-Related Liver Protection in Leukemia and Lymphoma

Phase 3

Waitlist Available

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

No Placebo-Only Group

Pivotal Trial

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of conjugated hyperbilirubinemia >3 mg/dL during induction therapy

Secondary study objectives

Alanine Transaminase

Incidence of minimal residual disease (MRD) positivity (MRD >= 0.01%)

Other study objectives

Adherence to oral levocarnitine during induction chemotherapy measured by percentage of pills returned relative to those prescribed

Levocarnitine

Asparaginase activity

+14 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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 3

~2030

Levocarnitine

1996

Completed Phase 3

~510