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

NCT03564678 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: 2017-0978NCI-2018-01253
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Lymphoblastic Leukemia; Hyperbilirubinemia

Outcome Measures

Primary Outcomes (1)

• Number of Participants With a Response

  Normalization of hyperbilirubinemia (Total bilirubin \< 1.5 x ULN) or at least 50% reduction in peak total bilirubin within 11 days.

  Up to 11 days

Study Arms (1)

Treatment (levocarnitine, vitamin B complex)

EXPERIMENTAL

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.

Dietary Supplement: Levocarnitine; Drug: Vitamin B Complex

Interventions

Levocarnitine DIETARY_SUPPLEMENT

Given IV

Also known as: Carnitor, L-carnitine

Treatment (levocarnitine, vitamin B complex)

Vitamin B Complex DRUG

Given PO

Also known as: Becotin, Neurobion

Treatment (levocarnitine, vitamin B complex)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Hyperbilirubinemia

Interventions

Carnitine; Vitamin B Complex; Folic Acid

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Vitamins; Micronutrients; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Elias Jabbour MD/Professor
• Organization: The University of Texas MD Anderson Cancer Center

ejabbour@mdanderson.org

713-792-4764

Study Officials

• Elias Jabbour

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2018
• First Posted: June 21, 2018
• Study Start: May 17, 2018
• Primary Completion: October 15, 2024
• Study Completion: October 15, 2024
• Last Updated: September 5, 2025
• Results First Posted: September 5, 2025

Record last verified: 2025-08

Locations

US (1)