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Amino Acid
Levocarnitine + Vitamin B Complex for Jaundice in Acute Lymphoblastic Leukemia
Phase 2
Recruiting
Led By Elias Jabbour
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with a diagnosis of ALL who are receiving treatment with PEG-asparaginase or inotuzumab ozogamicin with Tbili > 3 x ULN
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days after completion of treatment
Awards & highlights
Study Summary
This trial is testing the effectiveness of levocarnitine and vitamin B complex in treating patients with high liver enzyme levels caused by cancer treatment.
Who is the study for?
This trial is for patients with acute lymphoblastic leukemia who are experiencing high liver enzyme levels due to treatment with PEG-asparaginase or inotuzumab ozogamicin. Participants must have signed an informed consent and have a bilirubin level more than three times the upper limit of normal. Pregnant or nursing women, or those allergic to levocarnitine or vitamin B complex, cannot join.Check my eligibility
What is being tested?
The study is testing whether levocarnitine (an amino acid) and vitamin B complex can treat hyperbilirubinemia caused by certain leukemia treatments. The aim is to see if these supplements can normalize liver enzymes better than current practices.See study design
What are the potential side effects?
Potential side effects may include reactions related to levocarnitine such as nausea, vomiting, stomach upset, heartburn, diarrhea, and seizures; and from vitamin B complex like excessive thirst, skin conditions, blurry vision, abdominal cramps, nausea.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have ALL and am being treated with specific drugs, but my liver tests are high.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the start of study treatment up to 30 days after completion of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the start of study treatment up to 30 days after completion of treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Response rates
Secondary outcome measures
Evaluation of chemotherapy dose intensity
Incidence of adverse events
Other outcome measures
Time to hyperbilirubinemia normalization
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (levocarnitine, vitamin B complex)Experimental Treatment2 Interventions
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Levocarnitine
1996
Completed Phase 3
~510
Vitamin B Complex
2011
Completed Phase 3
~100
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,776 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,312 Total Patients Enrolled
Elias JabbourPrincipal InvestigatorM.D. Anderson Cancer Center
16 Previous Clinical Trials
950 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to levocarnitine or vitamin B complex.I have ALL and am being treated with specific drugs, but my liver tests are high.You are pregnant or breastfeeding.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (levocarnitine, vitamin B complex)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can people still volunteer for this experiment?
"Yes, that is correct. The medical trial was initially posted on May 17th, 2018 and the most recent update was November 7th, 2022. 78 people are needed for this study which is only at one location."
Answered by AI
What are some of the common illnesses that Levocarnitine is known to alleviate?
"The use of Levocarnitine can mitigate the risks and symptoms associated with thiamine deficiency, such as increased susceptibility to infection, acrodynia, and cardiovascular heart disease."
Answered by AI
How many participants are being asked to join this research project?
"Yes, that is accurate. The clinicaltrials.gov website provides information showing that this trial is still recruiting patients. This study was first posted on May 17th 2018, and the most recent update was on November 7th 2020. They are looking for 78 participants at 1 location."
Answered by AI
What are some of the potential side effects that patients may experience when taking Levocarnitine?
"Because this is a Phase 2 trial, there is some data supporting safety but none supporting efficacy. Our team at Power estimates the safety of Levocarnitine to be a 2 on a scale from 1 to 3."
Answered by AI
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