Trial Outcomes & Findings for Levocarnitine and Vitamin B Complex in Treating PEG-Asparaginase or Inotuzumab Ozogamicin-Induced Hyperbilirubinemia in Patients With Acute Lymphoblastic Leukemia (NCT NCT03564678)
NCT ID: NCT03564678
Last Updated: 2025-09-05
Results Overview
Normalization of hyperbilirubinemia (Total bilirubin \< 1.5 x ULN) or at least 50% reduction in peak total bilirubin within 11 days.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
Up to 11 days
Results posted on
2025-09-05
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Levocarnitine and Vitamin B Complex in Treating PEG-Asparaginase or Inotuzumab Ozogamicin-Induced Hyperbilirubinemia in Patients With Acute Lymphoblastic Leukemia
Baseline characteristics by cohort
| Measure |
Treatment (Levocarnitine, Vitamin B Complex)
n=10 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
41 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 11 daysNormalization of hyperbilirubinemia (Total bilirubin \< 1.5 x ULN) or at least 50% reduction in peak total bilirubin within 11 days.
Outcome measures
| Measure |
Treatment (Levocarnitine, Vitamin B Complex)
n=10 Participants
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
|
|---|---|
|
Number of Participants With a Response
|
8 Participants
|
Adverse Events
Treatment (Levocarnitine, Vitamin B Complex)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment (Levocarnitine, Vitamin B Complex)
n=10 participants at risk
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
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
1/10 • Number of events 1 • Up to 6 years, 4 months and 28 days
|
|
Investigations
Alanine aminotranserase increased
|
40.0%
4/10 • Number of events 5 • Up to 6 years, 4 months and 28 days
|
|
Investigations
alkaline phos increased
|
40.0%
4/10 • Number of events 4 • Up to 6 years, 4 months and 28 days
|
|
Blood and lymphatic system disorders
Anemia
|
70.0%
7/10 • Number of events 8 • Up to 6 years, 4 months and 28 days
|
|
Investigations
Aspartate aminotransferase increased
|
40.0%
4/10 • Number of events 4 • Up to 6 years, 4 months and 28 days
|
|
Infections and infestations
Bacteremia
|
20.0%
2/10 • Number of events 2 • Up to 6 years, 4 months and 28 days
|
|
Investigations
blood bilirubin increased
|
50.0%
5/10 • Number of events 5 • Up to 6 years, 4 months and 28 days
|
|
Hepatobiliary disorders
Cholecystitis
|
10.0%
1/10 • Number of events 1 • Up to 6 years, 4 months and 28 days
|
|
Investigations
creatinine increased
|
10.0%
1/10 • Number of events 1 • Up to 6 years, 4 months and 28 days
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
50.0%
5/10 • Number of events 5 • Up to 6 years, 4 months and 28 days
|
|
Infections and infestations
herpes simplex reactivation
|
20.0%
2/10 • Number of events 2 • Up to 6 years, 4 months and 28 days
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
10.0%
1/10 • Number of events 1 • Up to 6 years, 4 months and 28 days
|
|
Metabolism and nutrition disorders
hypertriglyceridemia
|
10.0%
1/10 • Number of events 1 • Up to 6 years, 4 months and 28 days
|
|
Metabolism and nutrition disorders
hypokalemia
|
10.0%
1/10 • Number of events 1 • Up to 6 years, 4 months and 28 days
|
|
Gastrointestinal disorders
ileal obstruction
|
10.0%
1/10 • Number of events 1 • Up to 6 years, 4 months and 28 days
|
|
Investigations
INR increased
|
50.0%
5/10 • Number of events 6 • Up to 6 years, 4 months and 28 days
|
|
Infections and infestations
lung infection
|
20.0%
2/10 • Number of events 2 • Up to 6 years, 4 months and 28 days
|
|
Gastrointestinal disorders
nausea
|
10.0%
1/10 • Number of events 1 • Up to 6 years, 4 months and 28 days
|
|
Investigations
neutrophil count decreased
|
80.0%
8/10 • Number of events 9 • Up to 6 years, 4 months and 28 days
|
|
Gastrointestinal disorders
Pancreatitis
|
10.0%
1/10 • Number of events 1 • Up to 6 years, 4 months and 28 days
|
|
Investigations
Platelet count decreased
|
90.0%
9/10 • Number of events 10 • Up to 6 years, 4 months and 28 days
|
|
Investigations
Serum amylase increased
|
10.0%
1/10 • Number of events 1 • Up to 6 years, 4 months and 28 days
|
|
Investigations
Lipase Increased
|
10.0%
1/10 • Number of events 1 • Up to 6 years, 4 months and 28 days
|
|
Investigations
White blood cell count decreased
|
90.0%
9/10 • Number of events 10 • Up to 6 years, 4 months and 28 days
|
Additional Information
Elias Jabbour MD/Professor
The University of Texas MD Anderson Cancer Center
Phone: 713-792-4764
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place