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Levocarnitine Prophylaxis for Asparaginase-Associated Hepatotoxicity in ALL
NCT05602194Phase 3
Key facts
- Status
- Active, not recruiting
- Start
- Aug 2023
- Primary completion
- Sep 2026
- Countries
- 2
- Sponsor
- Children's Oncology Group
- Modality
- Small Molecules
- Drugs
- levocarnitine
- Conditions
- hepatotoxicity
01
Overview
Phase 3, randomised, open-label trial in hepatotoxicity comparing Arm A (levocarnitine, standard of care chemotherapy), Arm B (standard of care chemotherapy) and Arm C (rescue levocarnitine) (3 arms). Primary endpoint: Incidence of conjugated hyperbilirubinemia > 3 mg/dL up to 35 days. Started Aug 2023; status: active, not recruiting.
02
Design
3 arms- Study design
- RandomizedOpen-label
Arm A (levocarnitine, standard of care chemotherapy)
Levocarnitine PO TID or IV + standard of care induction chemotherapy with pegaspargase or calaspargase pegol.
Arm B (standard of care chemotherapy)
Standard of care induction chemotherapy with pegaspargase or calaspargase pegol.
Arm C (rescue levocarnitine)
Levocarnitine rescue PO TID or IV for patients developing conjugated hyperbilirubinemia > 3 mg/dL.
03
Who it enrols
Patients aged 15-39 with newly diagnosed ALL, LLy, or MPAL, with adequate liver and kidney function, and no prior malignancies or severe liver disease.
04
Endpoints
Primary
Incidence of conjugated hyperbilirubinemia > 3 mg/dL
Secondary
Incidence of grade >= 3 alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevations
Incidence of minimal residual disease (MRD) positivity
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