Treatment of Hyperbilirubinemia Due to PEG-asparaginase and Inotuzumab Ozogamicin in Acute Lymphoblastic Leukemia (ALL)
| Status: | Recruiting |
|---|---|
| Conditions: | Blood Cancer, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Oncology |
| Healthy: | No |
| Age Range: | 12 - Any |
| Updated: | 8/1/2018 |
| Start Date: | May 17, 2018 |
| End Date: | December 2020 |
| Contact: | Elias Jabbour, MD |
| Email: | ejabbour@mdanderson.org |
| Phone: | 713-792-4764 |
Mitochondrial Cofactors for the Treatment of Hyperbilirubinemia Due to PEG-asparaginase and or Inotuzumab Ozogamicin in Patients With Acute Lymphoblastic Leukemia (ALL)
Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential
participant.
The goal of this clinical research study is to learn if a combination of levocarnitine and
Vitamin B complex capsules can help control treatment-related hyperbilirubinemia (a liver
side effect) in patients with acute lymphoblastic leukemia (ALL). Hyperbilirubinemia may
cause yellowing of the skin and/or eyes.
The safety of this combination will also be studied.
This is an investigational study. Levocarnitine is FDA approved and commercially available
for the treatment of carnitine deficiency, a decreased ability to turn fats to energy.
Vitamin B complex is commercially available. As a dietary supplement, Vitamin B complex does
not require approval by the FDA.
Combining levocarnitine and Vitamin B complex to help control abnormal liver tests in ALL is
considered investigational.
The study doctor can explain how the study drug and supplement are designed to work.
Up to 78 participants will be enrolled in this study. All will take part at MD Anderson.
participant.
The goal of this clinical research study is to learn if a combination of levocarnitine and
Vitamin B complex capsules can help control treatment-related hyperbilirubinemia (a liver
side effect) in patients with acute lymphoblastic leukemia (ALL). Hyperbilirubinemia may
cause yellowing of the skin and/or eyes.
The safety of this combination will also be studied.
This is an investigational study. Levocarnitine is FDA approved and commercially available
for the treatment of carnitine deficiency, a decreased ability to turn fats to energy.
Vitamin B complex is commercially available. As a dietary supplement, Vitamin B complex does
not require approval by the FDA.
Combining levocarnitine and Vitamin B complex to help control abnormal liver tests in ALL is
considered investigational.
The study doctor can explain how the study drug and supplement are designed to work.
Up to 78 participants will be enrolled in this study. All will take part at MD Anderson.
Study Drug/Supplement Administration:
If you are found to be eligible to take part in this study, and your blood tests show that
you have hyperbilirubinemia, you will start taking levocarnitine and Vitamin B complex.
- You will receive levocarnitine by vein over about 30-60 minutes 4 times a day (every 6
hours). Your dose of levocarnitine may be increased, depending on how you respond to
treatment.
- You will take Vitamin B complex capsules by mouth 2 times a day.
If you miss or vomit any doses of taking levocarnitine or Vitamin B complex by mouth, do not
make up the doses. Just wait until your next scheduled dose.
The study drug/supplement may be given to you as an inpatient in the hospital (preferred) or
as an outpatient.
However, if your doctor thinks it is appropriate for you to leave the hospital, you may
continue to receive levocarnitine by vein and Vitamin B complex by mouth as an outpatient.
Vitamin B complex taken by mouth would be any commercially available Vitamin B complex
product.
If you are unable to continue levocarnitine by vein, you may take levocarnitine by mouth 3
times a day until the liver test has improved.
Study Visits:
At least 1 time each week, blood (about 2-3 tablespoons) will be drawn for routine tests.
If it is more convenient for you, you may have some of the blood tests performed at your
local doctor's office or clinic. Your local doctor will tell the study doctor at MD Anderson
the test results. The study doctor and/or study staff will discuss this option with you.
Length of Treatment:
You may receive levocarnitine and Vitamin B complex until the hyperbilirubinemia has improved
or for up to 30 days after your last dose of PEG asparaginase or inotuzumab. However, if the
hyperbilirubinemia improves and then later comes back during follow-up, you may receive
levocarnitine and Vitamin B again at the previous dose level and continue until the
hyperbilirubinemia has improved.
You will no longer be able to take the study drug/supplement if intolerable side effects
occur, or if you are unable to follow study directions.
Your participation on the study will be over after the follow-up call.
Follow-Up:
About 30 days after your last dose of the study drug/supplement, you may be called by a
member of the study staff and asked how you are doing and if you have started any new
medications. This call should last about 10 minutes.
If you are found to be eligible to take part in this study, and your blood tests show that
you have hyperbilirubinemia, you will start taking levocarnitine and Vitamin B complex.
- You will receive levocarnitine by vein over about 30-60 minutes 4 times a day (every 6
hours). Your dose of levocarnitine may be increased, depending on how you respond to
treatment.
- You will take Vitamin B complex capsules by mouth 2 times a day.
If you miss or vomit any doses of taking levocarnitine or Vitamin B complex by mouth, do not
make up the doses. Just wait until your next scheduled dose.
The study drug/supplement may be given to you as an inpatient in the hospital (preferred) or
as an outpatient.
However, if your doctor thinks it is appropriate for you to leave the hospital, you may
continue to receive levocarnitine by vein and Vitamin B complex by mouth as an outpatient.
Vitamin B complex taken by mouth would be any commercially available Vitamin B complex
product.
If you are unable to continue levocarnitine by vein, you may take levocarnitine by mouth 3
times a day until the liver test has improved.
Study Visits:
At least 1 time each week, blood (about 2-3 tablespoons) will be drawn for routine tests.
If it is more convenient for you, you may have some of the blood tests performed at your
local doctor's office or clinic. Your local doctor will tell the study doctor at MD Anderson
the test results. The study doctor and/or study staff will discuss this option with you.
Length of Treatment:
You may receive levocarnitine and Vitamin B complex until the hyperbilirubinemia has improved
or for up to 30 days after your last dose of PEG asparaginase or inotuzumab. However, if the
hyperbilirubinemia improves and then later comes back during follow-up, you may receive
levocarnitine and Vitamin B again at the previous dose level and continue until the
hyperbilirubinemia has improved.
You will no longer be able to take the study drug/supplement if intolerable side effects
occur, or if you are unable to follow study directions.
Your participation on the study will be over after the follow-up call.
Follow-Up:
About 30 days after your last dose of the study drug/supplement, you may be called by a
member of the study staff and asked how you are doing and if you have started any new
medications. This call should last about 10 minutes.
Inclusion Criteria:
1. Patients at least 12 years of age
2. Patients with a diagnosis of ALL who are receiving treatment with PEG-asparaginase or
inotuzumab ozogamicin with Tbili >3xULN
3. Signed informed consent.
Exclusion Criteria:
1. Pregnant or nursing women
2. Known hypersensitivity to levocarnitine or vitamin B complex
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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