TerminatedPhase 2

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

Stopped: PI Request. Slow accrual and lack of clinical interest

United States10 participantsStarted 2018-05-17

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of Participants With a Response

Timeframe: Up to 11 days

Trial details

NCT IDNCT03564678

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-15

Results submitted2025-08-18

View on ClinicalTrials.gov More Acute Lymphoblastic Leukemia trials