CI

At a glance

ClinicalIndex Comparison Record
Phase 2Terminated· 10 enrolled
Drug / intervention
Vitamin B Complex +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03564678
NCT03564678Phase 2Terminated
Terminated

Mitochondrial Cofactors for the Treatment of Hyperbilirubinemia Due to PEG-Asparaginase and or Inotuzumab Ozogamicin in Patients With Acute Lymphoblastic Leukemia (ALL)

M.D. Anderson Cancer Center·interventional·Posted Jun 21, 2018·Updated Sep 5, 2025

In Brief

A Phase 2 clinical trial evaluating Levocarnitine and Vitamin B Complex for Acute Lymphoblastic Leukemia and Hyperbilirubinemia. Terminated early, enrolled 10 participants across 1 site.

Signals

Trial was terminated early

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2TerminatedFinished
20192020202120222023202420252026
First PostedJun 21, 2018
Enrollment StartMay 17, 2018
Primary CompletionOct 15, 2024
TodayJul 1, 2026
Enrollment to primary: 6.4 yearsPosted 8.0 years ago

Interventions

Levocarnitinedietary

Given IV

Vitamin B Complexdrug

Given PO