Levocarnitine and Vitamin B Complex in Treating PEG-Asparaginase or Inotuzumab Ozogamicin-Induced Hyperbilirubinemia in Patients With Acute Lymphoblastic Leukemia

Phase 2

Terminated

• Conditions: Acute Lymphoblastic Leukemia; Hyperbilirubinemia
• Interventions: Dietary Supplement: Levocarnitine; Drug: Vitamin B Complex

• Registration Number: NCT03564678
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

This phase II trial studies how well levocarnitine and vitamin B complex works in treating abnormal high liver enzyme levels (hyperbilirubinemia) caused by treatment with PEG-asparaginase or inotuzumab ozogamicin in patients with acute lymphoblastic leukemia. Amino acids, such as levocarnitine, may work in normalizing liver enzyme levels due to treatment. Vitamin B complex is a dietary supplement that may be used for patients with nutritional deficiencies. Giving levocarnitine and vitamin B complex may work better in treating hyperbilirubinemia in patients with acute lymphoblastic leukemia.

Detailed Description

Patients receive levocarnitine intravenously (IV) over 2-3 minutes every 6 hours up to 4 times a day (inpatient) or orally (PO) three times a day (TID) (outpatient). Patients also receive vitamin B complex PO twice daily (BID). Treatment continues for up to 30 days after the last dose of either PEG-asparaginase or inotuzumab, or until Tbili of ≤ 1.5 x ULN or at least a 50% reduction in peak Tbili is achieved.

After completion of study treatment, patients are followed up at 30 days.

Study Timeline

• Study Start: 2018-05-17
• Study First Submitted: 2018-05-18
• Study First Submitted QC: 2018-06-19
• Study First Posted: 2018-06-21
• Primary Completion: 2024-10-15
• Study Completion: 2024-10-15
• Status Verified: 2025-08
• Results First Submitted: 2025-08-18
• Results First Submitted QC: 2025-08-18
• Last Update Submitted: 2025-08-18
• Results First Posted: 2025-09-05
• Last Update Posted: 2025-09-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Patients at least 18 years of age.
• Non-English speakers may be enrolled.
• Patients with a diagnosis of ALL who are receiving treatment with PEG-asparaginase or inotuzumab ozogamicin with Tbili > 3 x ULN
• Signed informed consent

Exclusion Criteria

• Pregnant or nursing women
• Known hypersensitivity to levocarnitine or vitamin B complex

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (levocarnitine, vitamin B complex)	Levocarnitine	Patients receive levocarnitine IV over 2-3 minutes every 6 hours up to 4 times a day (inpatient) or PO TID (outpatient). Patients also receive vitamin B complex PO BID. Treatment continues for up to 30 days after the last dose of either PEG-asparaginase or inotuzumab, or until Tbili of ≤ 1.5 x ULN or at least a 50% reduction in peak Tbili is achieved.
Treatment (levocarnitine, vitamin B complex)	Vitamin B Complex	Patients receive levocarnitine IV over 2-3 minutes every 6 hours up to 4 times a day (inpatient) or PO TID (outpatient). Patients also receive vitamin B complex PO BID. Treatment continues for up to 30 days after the last dose of either PEG-asparaginase or inotuzumab, or until Tbili of ≤ 1.5 x ULN or at least a 50% reduction in peak Tbili is achieved.

Primary Outcome Measures

Name	Time	Method
Number of Participants With a Response	Up to 11 days	Normalization of hyperbilirubinemia (Total bilirubin \< 1.5 x ULN) or at least 50% reduction in peak total bilirubin within 11 days.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States