Major Program
Supportive Care and Symptom Management
NCI Community Oncology Research Program
Research Group
Community Oncology and Prevention Trials
Sponsor
Children's Oncology Group
Status
Recruiting
ClinicalTrials.gov ID
For more information, see ClinicalTrials.gov NCT05602194
This phase III trial compares the effect of adding levocarnitine to standard chemotherapy 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.
Intervention
Biospecimen Collection, Calaspargase Pegol, Levocarnitine, Pegaspargase, Quality-of-Life Assessment
Condition
B Acute Lymphoblastic Leukemia, B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1, B Acute Lymphoblastic Leukemia, BCR-ABL1-Like, Lymphoblastic Lymphoma, Mixed Phenotype Acute Leukemia, T Acute Lymphoblastic Leukemia
Investigators
Etan Orgel, Kathleen J. Yost, Scott M. Bradfield, Site Public Contact, Jessica C. Hochberg, Jamie L. Dargart, Howland E. Crosswell, Jennifer A. Domm, Ashok B. Raj, Jose M. Esquilin, Eric J. Lowe, Bassem I. Razzouk, Kishor M. Bhende, Robert G. Irwin, Judy L. Felgenhauer, Lauren R. Weintraub, Jon M. Brandt, Joshua W. Goldman, Jacqueline N. Casillas, Rachael R. Schulte, Chana L. Glasser, Aniket Saha, Shannon M. Cohn, Thomas B. Alexander, Craig Lotterman, Susan J. Lindemulder, Jason M. Fixler, Susan E. Spiller, Emad K. Salman, Timothy C. Griffin, Colleen Mathews, Julienne Brackett, Sei-Gyung K. Sze, Rabi Hanna, Najat C. Daw, Fouad M. Hajjar, Don E. Eslin, Mark A. Ranalli, Iftikhar Hanif, Jing Chen, Duncan S. Stearns, Jagadeesh Ramdas, Erin K. Barr, William C. Petersen, Lindsey Murphy, Erlyn C. Smith, Rene Y. McNall-Knapp, Jennifer G. Michlitsch, Robin D. Hanson, Aman Wadhwa, Alissa Kahn, Laura E. Agresta, Erwood G. Edwards, Michaela Liedtke, David S. Dickens, Samuel J. Milanovich, Mukund G. Dole, Samantha L. Mallory, Robert M. Cooper, Kenneth Byrd, Karen S. Fernandez, Anne-Marie R. Langevin, Susan R. Rheingold, Scott C. Borinstein, Kayelyn J. Wagner, Sarah E. Leary, Erin H. Breese, Wendy Stock, William B. Slayton, Karen H. Albritton, Andrew J. Galligan, Gregory P. Brandt, Alice Lee, Craig Erker, Holly E. Pariury, Keith J. August, Michael J. Burke, Jessica M. Valdez, Michal Bar-Natan, Maggie E. Fader, Shira N. Dinner, James T. Badgett, David L. Becton, Jordyn R. Griffin, Stacy L. Cooper, Maria I. Castellanos