Summary

Eligibility
for people ages 15-40 (full criteria)
Location
at UCSF
Dates
study started
completion around
Principal Investigator
by Jennifer G. Michlitsch (ucsf)Maria I. Castellanos (ucsf)
Headshot of Jennifer G. Michlitsch
Jennifer G. Michlitsch
Headshot of Maria I. Castellanos
Maria I. Castellanos

Description

Summary

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.

Official Title

A Randomized Trial of Levocarnitine Prophylaxis to Prevent Asparaginase-Associated Hepatotoxicity in Adolescents and Young Adults Receiving Acute Lymphoblastic Leukemia Therapy

Details

Keywords

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, Lymphoma, Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoid Leukemia, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Asparaginase, Pegaspargase, Biospecimen Collection, Calaspargase Pegol, Levocarnitine, Quality-of-Life Assessment, rescue levocarnitine

Eligibility

Locations

Lead Scientists at University of California Health

  • Jennifer G. Michlitsch (ucsf)
    Professor, Pediatrics, School of Medicine. Authored (or co-authored) 23 research publications
  • Maria I. Castellanos (ucsf)
    My research goal is to characterize, study, and identify remedies to mitigate the socioeconomic, biological, and clinical factors that impact treatment outcomes and survival in children with cancer, with a specific interest in pediatric leukemias. I study geospatial differences among communities that impact cancer survival outcomes.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Children's Oncology Group
ID
NCT05602194
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 440 study participants
Last Updated