Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05602194 · ClinicalTrials.gov registry record · Phase 3
Studying the Effect of Levocarnitine in Protecting the Liver From Chemotherapy for Leukemia or Lymphoma
A Phase 3 study of Mixed Phenotype Acute Leukemia and Lymphoblastic Lymphoma, sponsored by Children's Oncology Group.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 440
- Enrollment target
- 20
- Study locations
NCT05602194 is a Phase 3 study of Mixed Phenotype Acute Leukemia and Lymphoblastic Lymphoma that is actively recruiting participants, run by Children's Oncology Group. The registered enrollment target is 440 participants, above the 384-participant average among 29 other Mixed Phenotype Acute Leukemia trials with a reported enrollment target (15% higher). The trial reports 20 study locations across 5 states.
The verdict
NCT05602194, a Phase 3 study of Mixed Phenotype Acute Leukemia and Lymphoblastic Lymphoma, is actively recruiting participants, sponsored by Children's Oncology Group.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 440 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- OTHER Quality-of-Life Assessment
- DRUG Calaspargase Pegol
- DIETARY_SUPPLEMENT Levocarnitine
- DRUG Pegaspargase
Study Locations (20)
California
- Kaiser Permanente-Anaheim - Anaheim
- PCR Oncology - Arroyo Grande
- Kaiser Permanente-Bellflower - Bellflower
- Kaiser Permanente Downey Medical Center - Downey
- City of Hope Comprehensive Cancer Center - Duarte
- Kaiser Permanente-Fontana - Fontana
- Loma Linda University Medical Center - Loma Linda
- Miller Children's and Women's Hospital Long Beach - Long Beach
- Children's Hospital Los Angeles - Los Angeles
- Kaiser Permanente Los Angeles Medical Center - Los Angeles
- Valley Children's Hospital - Madera
- UCSF Benioff Children's Hospital Oakland - Oakland
- Lucile Packard Children's Hospital Stanford University - Palo Alto
- Stanford Cancer Institute Palo Alto - Palo Alto
Arizona
- Kingman Regional Medical Center - Kingman
- Phoenix Childrens Hospital - Phoenix
- Banner University Medical Center - Tucson - Tucson
Alabama
- Children's Hospital of Alabama - Birmingham
Alaska
- Providence Alaska Medical Center - Anchorage
Arkansas
- Arkansas Children's Hospital - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 440 participants |
| Start Date | 2023-08-14 |
| Est. Completion | 2028-12-30 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05602194
The ClinicalTrials.gov registry entry for NCT05602194 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 440 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 384-participant average among 29 other Mixed Phenotype Acute Leukemia trials with a reported enrollment target (15% higher). The listed sponsor is Children's Oncology Group, which has 342 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Mixed Phenotype Acute Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05602194 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT05602194 about?
NCT05602194 is a clinical study titled "Studying the Effect of Levocarnitine in Protecting the Liver From Chemotherapy for Leukemia or Lymphoma". 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 leukemi...
What is the current status of trial NCT05602194?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 440 participants. The study started on 2023-08-14. Estimated completion is 2028-12-30.
What conditions does trial NCT05602194 study?
This clinical trial studies the following conditions: Mixed Phenotype Acute Leukemia, Lymphoblastic Lymphoma, B Acute Lymphoblastic Leukemia, B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1, T Acute Lymphoblastic Leukemia.
What interventions are being tested in trial NCT05602194?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Quality-of-Life Assessment (OTHER), Calaspargase Pegol (DRUG), Levocarnitine (DIETARY_SUPPLEMENT), Pegaspargase (DRUG).
Who is sponsoring clinical trial NCT05602194?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05602194 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Mixed Phenotype Acute Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy
RECRUITING · Phase 3
-
Mismatched Related Donor Versus Matched Unrelated Donor Stem Cell Transplantation for Children, Adolescents, and Young Adults With Acute Leukemia or Myelodysplastic Syndrome
ACTIVE NOT RECRUITING · Phase 3
-
Precision-T: A Randomized Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies
ACTIVE NOT RECRUITING · Phase 3
-
Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
ACTIVE NOT RECRUITING · Phase 3
-
The Pediatric Acute Leukemia (PedAL) Screening Trial - A Study to Test Bone Marrow and Blood in Children With Leukemia That Has Come Back After Treatment or Is Difficult to Treat - A Leukemia & Lymphoma Society and Children's Oncology Group Study
RECRUITING · Phase 1
-
A Phase 1 Study of Orca-Q in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies
RECRUITING · Phase 1
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.