Levocarnitine and Vitamin B Complex in Treating PEG-Asparaginase or Inotuzumab Ozogamicin-Induced Hyperbilirubinemia in Patients With Acute Lymphoblastic Leukemia
NCT ID: NCT03564678
Last Updated: 2025-09-05
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
10 participants
INTERVENTIONAL
2018-05-17
2024-10-15
Brief Summary
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Detailed Description
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After completion of study treatment, patients are followed up at 30 days.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Treatment (levocarnitine, 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.
Levocarnitine
Given IV
Vitamin B Complex
Given PO
Interventions
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Levocarnitine
Given IV
Vitamin B Complex
Given PO
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Known hypersensitivity to levocarnitine or vitamin B complex
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Elias Jabbour
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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MD Anderson Cancer Center
Other Identifiers
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NCI-2018-01253
Identifier Type: REGISTRY
Identifier Source: secondary_id
2017-0978
Identifier Type: OTHER
Identifier Source: secondary_id
2017-0978
Identifier Type: -
Identifier Source: org_study_id
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