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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-01253 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2017-0978 | Other Identifier | M D Anderson Cancer Center |
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PI Request. Slow accrual and lack of clinical interest
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
Patients receive levocarnitine intravenously (IV) over 2-3 minutes every 6 hours up to 4 times a day (inpatient) or orally (PO) three times a day (TID) (outpatient). Patients also receive vitamin B complex PO twice daily (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.
After completion of study treatment, patients are followed up at 30 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (levocarnitine, vitamin B complex) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levocarnitine | Dietary Supplement | Given IV |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Response | Normalization of hyperbilirubinemia (Total bilirubin < 1.5 x ULN) or at least 50% reduction in peak total bilirubin within 11 days. | Up to 11 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elias Jabbour | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 18, 2019 |
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| Vitamin B Complex | Drug | Given PO |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With a Response | Normalization of hyperbilirubinemia (Total bilirubin < 1.5 x ULN) or at least 50% reduction in peak total bilirubin within 11 days. | Posted | Count of Participants | Participants | Up to 11 days |
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Up to 6 years, 4 months and 28 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 10 | 0 | 10 | 9 | 10 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Alanine aminotranserase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| alkaline phos increased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Bacteremia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| blood bilirubin increased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
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| creatinine increased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| herpes simplex reactivation | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| hypertriglyceridemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| ileal obstruction | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| INR increased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| lung infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| neutrophil count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Platelet count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Serum amylase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Lipase Increased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| White blood cell count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elias Jabbour MD/Professor | The University of Texas MD Anderson Cancer Center | 713-792-4764 | ejabbour@mdanderson.org |
| Aug 4, 2025 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 19, 2022 | Oct 17, 2024 | ICF_000.pdf |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D006932 | Hyperbilirubinemia |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002331 | Carnitine |
| D014803 | Vitamin B Complex |
| D005492 | Folic Acid |
| ID | Term |
|---|---|
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D014815 | Vitamins |
| D018977 | Micronutrients |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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