ClinicalTrials.gov record
Studying the Effect of Levocarnitine in Protecting the Liver From Chemotherapy for Leukemia or Lymphoma
ClinicalTrials.gov ID: NCT05602194
Public ClinicalTrials.gov record NCT05602194. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized Trial of Levocarnitine Prophylaxis to Prevent Asparaginase-Associated Hepatotoxicity in Adolescents and Young Adults Receiving Acute Lymphoblastic Leukemia Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This phase III trial compares the effect of adding levocarnitine to standard chemotherapy versus (vs.) standard chemotherapy alone in protecting the liver in patients with leukemia or lymphoma. Asparaginase is part of the standard of care chemotherapy for the treatment of acute lymphoblastic leukemia (ALL), lymphoblastic lymphoma (LL), and mixed phenotype acute leukemia (MPAL). However, in adolescent and young adults (AYA) ages 15-39 years, liver toxicity from asparaginase is common and often prevents delivery of planned chemotherapy, thereby potentially compromising outcomes. Some groups of people may also be at higher risk for liver damage due to the presence of fat in the liver even before starting chemotherapy. Patients who are of Japanese descent, Native Hawaiian, Hispanic or Latinx may be at greater risk for liver damage from chemotherapy for this reason. Carnitine is a naturally occurring nutrient that is part of a typical diet and is also made by the body. Carnitine is necessary for metabolism and its deficiency or absence is associated with liver and other organ damage. Levocarnitine is a drug used to provide extra carnitine. Laboratory and real-world usage of the dietary supplement levocarnitine suggests its potential to prevent or reduce liver toxicity from asparaginase. The overall goal of this study is to determine whether adding levocarnitine to standard of care chemotherapy will reduce the chance of developing severe liver damage from asparaginase chemotherapy in ALL, LL and/or MPAL patients.
Study identification
- NCT ID
- NCT05602194
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 440 participants
Conditions and interventions
Conditions
Interventions
- Biospecimen Collection Procedure
- Calaspargase Pegol Drug
- Levocarnitine Dietary Supplement
- Pegaspargase Drug
- Quality-of-Life Assessment Other
Procedure · Drug · Dietary Supplement + 1 more
Eligibility (public fields only)
- Age range
- 15 Years to 40 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 24, 2023 (Actual)
- Primary completion
- Sep 30, 2026 (Estimated)
- Completion
- Dec 30, 2028 (Estimated)
- Last update posted
- Aug 21, 2026
2023 – 2028
United States locations
- U.S. sites
- 225
- U.S. states
- 42
- U.S. cities
- 152
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital of Alabama | Birmingham | Alabama | 35233 | — |
| Providence Alaska Medical Center | Anchorage | Alaska | 99508 | — |
| Kingman Regional Medical Center | Kingman | Arizona | 86401 | — |
| Phoenix Childrens Hospital | Phoenix | Arizona | 85016 | — |
| Banner University Medical Center - Tucson | Tucson | Arizona | 85719 | — |
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202-3591 | — |
| Kaiser Permanente-Anaheim | Anaheim | California | 92806 | — |
| PCR Oncology | Arroyo Grande | California | 93420 | — |
| Kaiser Permanente-Bellflower | Bellflower | California | 90706 | — |
| Kaiser Permanente Downey Medical Center | Downey | California | 90242 | — |
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010 | — |
| Kaiser Permanente-Fontana | Fontana | California | 92335 | — |
| Loma Linda University Medical Center | Loma Linda | California | 92354 | — |
| Miller Children's and Women's Hospital Long Beach | Long Beach | California | 90806 | — |
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | — |
| Kaiser Permanente Los Angeles Medical Center | Los Angeles | California | 90027 | — |
| Valley Children's Hospital | Madera | California | 93636 | — |
| UCSF Benioff Children's Hospital Oakland | Oakland | California | 94609 | — |
| Lucile Packard Children's Hospital Stanford University | Palo Alto | California | 94304 | — |
| Stanford Cancer Institute Palo Alto | Palo Alto | California | 94304 | — |
| Sutter Medical Center Sacramento | Sacramento | California | 95816 | — |
| University of California Davis Comprehensive Cancer Center | Sacramento | California | 95817 | — |
| Kaiser Permanente-San Diego Mission | San Diego | California | 92108 | — |
| Kaiser Permanente-San Diego Zion | San Diego | California | 92120 | — |
| UCSF Medical Center-Mission Bay | San Francisco | California | 94158 | — |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center | Denver | Colorado | 80218 | — |
| Alfred I duPont Hospital for Children | Wilmington | Delaware | 19803 | — |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | — |
| Golisano Children's Hospital of Southwest Florida | Fort Myers | Florida | 33908 | — |
| UF Health Cancer Institute - Gainesville | Gainesville | Florida | 32610 | — |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital | Hollywood | Florida | 33021 | — |
| Nemours Children's Clinic-Jacksonville | Jacksonville | Florida | 32207 | — |
| Nicklaus Children's Hospital | Miami | Florida | 33155 | — |
| Miami Cancer Institute | Miami | Florida | 33176 | — |
| AdventHealth Orlando | Orlando | Florida | 32803 | — |
| Nemours Children's Hospital | Orlando | Florida | 32827 | — |
| Nemours Children's Clinic - Pensacola | Pensacola | Florida | 32504 | — |
| Sacred Heart Hospital | Pensacola | Florida | 32504 | — |
| Johns Hopkins All Children's Hospital | St. Petersburg | Florida | 33701 | — |
| Tampa General Hospital | Tampa | Florida | 33606 | — |
| Saint Joseph's Hospital/Children's Hospital-Tampa | Tampa | Florida | 33607 | — |
| Children's Healthcare of Atlanta - Arthur M Blank Hospital | Atlanta | Georgia | 30329 | — |
| Memorial Health University Medical Center | Savannah | Georgia | 31404 | — |
| Kapiolani Medical Center for Women and Children | Honolulu | Hawaii | 96826 | — |
| Saint Luke's Cancer Institute - Boise | Boise | Idaho | 83712 | — |
| Saint Luke's Cancer Institute - Fruitland | Fruitland | Idaho | 83619 | — |
| Saint Luke's Cancer Institute - Meridian | Meridian | Idaho | 83642 | — |
| Saint Luke's Cancer Institute - Nampa | Nampa | Idaho | 83687 | — |
| Saint Luke's Cancer Institute - Twin Falls | Twin Falls | Idaho | 83301 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| University of Illinois | Chicago | Illinois | 60612 | — |
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637 | — |
| Advocate Children's Hospital-Oak Lawn | Oak Lawn | Illinois | 60453 | — |
| Advocate Children's Hospital-Park Ridge | Park Ridge | Illinois | 60068 | — |
| OSF Children's Hospital of Illinois | Peoria | Illinois | 61637 | — |
| Southern Illinois University School of Medicine | Springfield | Illinois | 62702 | — |
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | — |
| Ascension Saint Vincent Indianapolis Hospital | Indianapolis | Indiana | 46260 | — |
| Blank Children's Hospital | Des Moines | Iowa | 50309 | — |
| University of Iowa/Holden Comprehensive Cancer Center | Iowa City | Iowa | 52242 | — |
| University of Kansas Cancer Center | Kansas City | Kansas | 66160 | — |
| University of Kansas Hospital-Westwood Cancer Center | Westwood | Kansas | 66205 | — |
| University of Kentucky/Markey Cancer Center | Lexington | Kentucky | 40536 | — |
| Norton Children's Hospital | Louisville | Kentucky | 40202 | — |
| Children's Hospital New Orleans | New Orleans | Louisiana | 70118 | — |
| Ochsner Medical Center Jefferson | New Orleans | Louisiana | 70121 | — |
| Maine Children's Cancer Program | Scarborough | Maine | 04074 | — |
| Sinai Hospital of Baltimore | Baltimore | Maryland | 21215 | — |
| Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | 21287 | — |
| C S Mott Children's Hospital | Ann Arbor | Michigan | 48109 | — |
| University of Michigan Rogel Cancer Center | Ann Arbor | Michigan | 48109 | — |
| Bronson Battle Creek | Battle Creek | Michigan | 49017 | — |
| Children's Hospital of Michigan | Detroit | Michigan | 48201 | — |
| Michigan State University | East Lansing | Michigan | 48823 | — |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital | Grand Rapids | Michigan | 49503 | — |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital | Grand Rapids | Michigan | 49503 | — |
| Trinity Health Grand Rapids Hospital | Grand Rapids | Michigan | 49503 | — |
| Bronson Methodist Hospital | Kalamazoo | Michigan | 49007 | — |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007 | — |
| Beacon Kalamazoo Cancer Center | Kalamazoo | Michigan | 49009 | — |
| Beacon Kalamazoo | Kalamazoo | Michigan | 49048 | — |
| Trinity Health Muskegon Hospital | Muskegon | Michigan | 49444 | — |
| Corewell Health Lakeland Hospitals - Niles Hospital | Niles | Michigan | 49120 | — |
| Cancer and Hematology Centers of Western Michigan - Norton Shores | Norton Shores | Michigan | 49444 | — |
| Corewell Health Reed City Hospital | Reed City | Michigan | 49677 | — |
| Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center | Saint Joseph | Michigan | 49085 | — |
| Corewell Health Lakeland Hospitals - Saint Joseph Hospital | Saint Joseph | Michigan | 49085 | — |
| Munson Medical Center | Traverse City | Michigan | 49684 | — |
| University of Michigan Health - West | Wyoming | Michigan | 49519 | — |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | — |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | — |
| Children's Mercy Hospitals and Clinics | Kansas City | Missouri | 64108 | — |
| Mercy Hospital Saint Louis | St Louis | Missouri | 63141 | — |
| Children's Hospital and Medical Center of Omaha | Omaha | Nebraska | 68114 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | — |
| Carson Tahoe Regional Medical Center | Carson City | Nevada | 89703 | — |
| Comprehensive Cancer Centers of Nevada - Henderson | Henderson | Nevada | 89052 | — |
| Comprehensive Cancer Centers of Nevada-Horizon Ridge | Henderson | Nevada | 89052 | — |
| Comprehensive Cancer Centers of Nevada-Southeast Henderson | Henderson | Nevada | 89074 | — |
| Las Vegas Urology - Green Valley | Henderson | Nevada | 89074 | — |
| Las Vegas Urology - Pebble | Henderson | Nevada | 89074 | — |
| Oncology Las Vegas - Henderson | Henderson | Nevada | 89074 | — |
| Urology Specialists of Nevada - Green Valley | Henderson | Nevada | 89074 | — |
| Las Vegas Urology - Pecos | Las Vegas | Nevada | 89074 | — |
| OptumCare Cancer Care at Charleston | Las Vegas | Nevada | 89102 | — |
| University Medical Center of Southern Nevada | Las Vegas | Nevada | 89102 | — |
| Hope Cancer Care of Nevada | Las Vegas | Nevada | 89103 | — |
| Radiation Oncology Centers of Nevada Central | Las Vegas | Nevada | 89106 | — |
| Urology Specialists of Nevada - Central | Las Vegas | Nevada | 89106 | — |
| Sunrise Hospital and Medical Center | Las Vegas | Nevada | 89109 | — |
| Las Vegas Urology - Sunset | Las Vegas | Nevada | 89113 | — |
| Urology Specialists of Nevada - Southwest | Las Vegas | Nevada | 89113 | — |
| Radiation Oncology Centers of Nevada Southeast | Las Vegas | Nevada | 89119 | — |
| Ann M Wierman MD LTD | Las Vegas | Nevada | 89128 | — |
| Comprehensive Cancer Centers of Nevada - Northwest | Las Vegas | Nevada | 89128 | — |
| Las Vegas Urology - Cathedral Rock | Las Vegas | Nevada | 89128 | — |
| Las Vegas Urology - Smoke Ranch | Las Vegas | Nevada | 89128 | — |
| Oncology Las Vegas - Tenaya | Las Vegas | Nevada | 89128 | — |
| OptumCare Cancer Care at MountainView | Las Vegas | Nevada | 89128 | — |
| Urology Specialists of Nevada - Northwest | Las Vegas | Nevada | 89128 | — |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation | Las Vegas | Nevada | 89135 | — |
| Comprehensive Cancer Centers of Nevada - Town Center | Las Vegas | Nevada | 89144 | — |
| Comprehensive Cancer Centers of Nevada-Summerlin | Las Vegas | Nevada | 89144 | — |
| Summerlin Hospital Medical Center | Las Vegas | Nevada | 89144 | — |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89148 | — |
| Comprehensive Cancer Centers of Nevada - Central Valley | Las Vegas | Nevada | 89169 | — |
| OptumCare Cancer Care at Fort Apache | Las Vegas | Nevada | 89183 | — |
| Hope Cancer Care of Nevada-Pahrump | Pahrump | Nevada | 89048 | — |
| Renown Regional Medical Center | Reno | Nevada | 89502 | — |
| Saint Mary's Regional Medical Center | Reno | Nevada | 89503 | — |
| Radiation Oncology Associates | Reno | Nevada | 89509 | — |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| Jersey Shore Medical Center | Neptune City | New Jersey | 07753 | — |
| Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital | New Brunswick | New Jersey | 08903 | — |
| Newark Beth Israel Medical Center | Newark | New Jersey | 07112 | — |
| Saint Joseph's Regional Medical Center | Paterson | New Jersey | 07503 | — |
| Presbyterian Hospital | Albuquerque | New Mexico | 87106 | — |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87106 | — |
| Albany Medical Center | Albany | New York | 12208 | — |
| Maimonides Medical Center | Brooklyn | New York | 11219 | — |
| NYU Langone Hospital - Long Island | Mineola | New York | 11501 | — |
| The Steven and Alexandra Cohen Children's Medical Center of New York | New Hyde Park | New York | 11040 | — |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone | New York | New York | 10016 | — |
| NYP/Weill Cornell Medical Center | New York | New York | 10065 | — |
| Stony Brook University Medical Center | Stony Brook | New York | 11794 | — |
| Montefiore Medical Center-Einstein Campus | The Bronx | New York | 10461 | — |
| Montefiore Medical Center-Weiler Hospital | The Bronx | New York | 10461 | — |
| Children's Hospital at Montefiore | The Bronx | New York | 10467 | — |
| Montefiore Medical Center - Moses Campus | The Bronx | New York | 10467 | — |
| New York Medical College | Valhalla | New York | 10595 | — |
| UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | — |
| Carolinas Medical Center/Levine Cancer Institute | Charlotte | North Carolina | 28203 | — |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | — |
| Sanford Broadway Medical Center | Fargo | North Dakota | 58122 | — |
| Children's Hospital Medical Center of Akron | Akron | Ohio | 44308 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| Rainbow Babies and Childrens Hospital | Cleveland | Ohio | 44106 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | — |
| Dayton Children's Hospital | Dayton | Ohio | 45404 | — |
| ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital | Toledo | Ohio | 43606 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Saint Francis Children's Hospital | Tulsa | Oklahoma | 74136 | — |
| Oregon Health and Science University | Portland | Oregon | 97239 | — |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | — |
| Penn State Children's Hospital | Hershey | Pennsylvania | 17033 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | — |
| Prisma Health Richland Hospital | Columbia | South Carolina | 29203 | — |
| Saint Francis Hospital | Greenville | South Carolina | 29601 | — |
| BI-LO Charities Children's Cancer Center | Greenville | South Carolina | 29605 | — |
| Prisma Health Greenville Memorial Hospital | Greenville | South Carolina | 29605 | — |
| Saint Francis Cancer Center | Greenville | South Carolina | 29607 | — |
| Prisma Health Cancer Institute - Eastside | Greenville | South Carolina | 29615 | — |
| Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota | 57117-5134 | — |
| East Tennessee Childrens Hospital | Knoxville | Tennessee | 37916 | — |
| The Children's Hospital at TriStar Centennial | Nashville | Tennessee | 37203 | — |
| Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee | 37232 | — |
| Dell Children's Medical Center of Central Texas | Austin | Texas | 78723 | — |
| Driscoll Children's Hospital | Corpus Christi | Texas | 78411 | — |
| Medical City Dallas Hospital | Dallas | Texas | 75230 | — |
| UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | 75390 | — |
| El Paso Children's Hospital | El Paso | Texas | 79905 | — |
| Cook Children's Medical Center | Fort Worth | Texas | 76104 | — |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center | Houston | Texas | 77030 | — |
| UT MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Covenant Children's Hospital | Lubbock | Texas | 79410 | — |
| UMC Cancer Center / UMC Health System | Lubbock | Texas | 79415 | — |
| Vannie Cook Children's Clinic | McAllen | Texas | 78503 | — |
| Children's Hospital of San Antonio | San Antonio | Texas | 78207 | — |
| Methodist Children's Hospital of South Texas | San Antonio | Texas | 78229 | — |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | — |
| University of Virginia Cancer Center | Charlottesville | Virginia | 22908 | — |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | — |
| Children's Hospital of The King's Daughters | Norfolk | Virginia | 23507 | — |
| VCU Massey Comprehensive Cancer Center | Richmond | Virginia | 23298 | — |
| Carilion Children's | Roanoke | Virginia | 24014 | — |
| Valley Medical Center | Renton | Washington | 98055 | — |
| Seattle Children's Hospital | Seattle | Washington | 98105 | — |
| Providence Sacred Heart Medical Center and Children's Hospital | Spokane | Washington | 99204 | — |
| Mary Bridge Children's Hospital and Health Center | Tacoma | Washington | 98405 | — |
| Madigan Army Medical Center | Tacoma | Washington | 98431 | — |
| North Star Lodge Cancer Center at Yakima Valley Memorial Hospital | Yakima | Washington | 98902 | — |
| Aurora Cancer Care-Southern Lakes VLCC | Burlington | Wisconsin | 53105 | — |
| Aurora Saint Luke's South Shore | Cudahy | Wisconsin | 53110 | — |
| Aurora Health Care Germantown Health Center | Germantown | Wisconsin | 53022 | — |
| Aurora Cancer Care-Grafton | Grafton | Wisconsin | 53024 | — |
| Aurora BayCare Medical Center | Green Bay | Wisconsin | 54311 | — |
| Aurora Cancer Care-Kenosha South | Kenosha | Wisconsin | 53142 | — |
| University of Wisconsin Carbone Cancer Center - Eastpark Medical Center | Madison | Wisconsin | 53718 | — |
| University of Wisconsin Carbone Cancer Center - University Hospital | Madison | Wisconsin | 53792 | — |
| Aurora Bay Area Medical Group-Marinette | Marinette | Wisconsin | 54143 | — |
| Marshfield Medical Center-Marshfield | Marshfield | Wisconsin | 54449 | — |
| Aurora Cancer Care-Milwaukee | Milwaukee | Wisconsin | 53209 | — |
| Aurora Saint Luke's Medical Center | Milwaukee | Wisconsin | 53215 | — |
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
| Aurora Sinai Medical Center | Milwaukee | Wisconsin | 53233 | — |
| Vince Lombardi Cancer Clinic - Oshkosh | Oshkosh | Wisconsin | 54904 | — |
| Aurora Cancer Care-Racine | Racine | Wisconsin | 53406 | — |
| Vince Lombardi Cancer Clinic-Sheboygan | Sheboygan | Wisconsin | 53081 | — |
| Aurora Medical Center in Summit | Summit | Wisconsin | 53066 | — |
| Vince Lombardi Cancer Clinic-Two Rivers | Two Rivers | Wisconsin | 54241 | — |
| Aurora Cancer Care-Milwaukee West | Wauwatosa | Wisconsin | 53226 | — |
| Aurora West Allis Medical Center | West Allis | Wisconsin | 53227 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05602194, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 21, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05602194 live on ClinicalTrials.gov.