Improved survival for children and adolescents with acute lymphoblastic leukemia between 1990 and 2005: a report from the children's oncology group.
Stephen P Hunger, Xiaomin Lu, Meenakshi Devidas...
https://pubmed.ncbi.nlm.nih.gov/22412151Actively Recruiting
Early Phase 1
Age: 5Years - 29Years
All Genders
ID05501899
Use of Levocarnitine to Reduce Asparaginase Hepatotoxicity in Patients With Acute Lymphoblastic Leukemia
Led by Children's Hospital of Orange County · Updated on 2024-08-21
20
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Children's Hospital of Orange County
Lead Sponsor
U
University of California, Irvine
Collaborating Sponsor
AI-Summary
What this Trial Is About
Acute lymphoblastic leukemia (ALL) is the most common cancer in children and young adults. This research evaluates whether giving oral levocarnitine during the early chemotherapy phases can reduce liver damage caused by asparaginase, a chemotherapy drug known for its liver toxicity. The study also looks at how factors like ethnicity and body weight might affect liver problems during treatment. Participants will receive levocarnitine twice daily by mouth during the Induction and Consolidation treatment phases, lasting about three months. Dosage depends on weight: adults or those 50 kg and above receive 990 mg twice daily, while children under 50 kg receive 50 mg per kg per day divided into two doses. The study compares these patients with a matched group from past records who did not receive levocarnitine. During the study, participants will have regular lab tests to monitor liver function and other potential side effects such as blood sugar changes, pancreatitis, and blood clots. Ultrasound scans assess fatty liver disease. The main outcomes include liver test results and disease response after treatment. The total follow-up period is around 1.5 years, with safety and treatment effects closely tracked throughout.
CONDITIONS
Brief Title
Use of Levocarnitine to Reduce Asparaginase Hepatotoxicity in Patients With Acute Lymphoblastic Leukemia
Who Can Participate
Age: 5Years - 29Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients aged 5 to less than 30 years
- Newly diagnosed with high-risk acute lymphoblastic leukemia (ALL)
- Planned treatment according to a Children's Oncology Group (COG) protocol
- Able to take oral medications and willing to follow the levocarnitine regimen
You will not qualify if you...
- Known allergy to levocarnitine or its components
- Severe kidney problems or end-stage renal disease
- Pregnancy or breastfeeding
- Currently taking warfarin
- History of seizures before ALL diagnosis
- Known inherited metabolic disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 3 months
Participants receive levocarnitine by mouth twice daily during the Induction and Consolidation phases of their ALL treatment according to a Children's Oncology Group protocol.
Visits occur as part of routine COG treatment during Induction and Consolidation phases
Trial Site Locations
Total: 2 locations
1
Chao Family Comprehensive Cancer Center, University of California, Irvine
Orange, California, United States, 92868
Actively Recruiting
2
Children's Hospital of Orange County
Orange, California, United States, 92868
Actively Recruiting
Loading map...
Research Team
V
Van T. Huynh, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Survival variability by race and ethnicity in childhood acute lymphoblastic leukemia.
Nina S Kadan-Lottick, Kirsten K Ness, Smita Bhatia...
https://pubmed.ncbi.nlm.nih.gov/14559954Long-term outcome of a pediatric-inspired regimen used for adults aged 18-50 years with newly diagnosed acute lymphoblastic leukemia.
D J DeAngelo, K E Stevenson, S E Dahlberg...
https://pubmed.ncbi.nlm.nih.gov/25079173A pediatric regimen for older adolescents and young adults with acute lymphoblastic leukemia: results of CALGB 10403.
Wendy Stock, Selina M Luger, Anjali S Advani...
https://pubmed.ncbi.nlm.nih.gov/30658992Toxicity profile of repeated doses of PEG-asparaginase incorporated into a pediatric-type regimen for adult acute lymphoblastic leukemia.
Ibrahim Aldoss, Dan Douer, Carolyn E Behrendt...
https://pubmed.ncbi.nlm.nih.gov/26095294Tolerability and efficacy of L-asparaginase therapy in pediatric patients with acute lymphoblastic leukemia.
Elizabeth A Raetz, Wanda L Salzer
https://pubmed.ncbi.nlm.nih.gov/20724951Prevalence of childhood and adult obesity in the United States, 2011-2012.
Cynthia L Ogden, Margaret D Carroll, Brian K Kit...
https://pubmed.ncbi.nlm.nih.gov/24570244Consensus expert recommendations for identification and management of asparaginase hypersensitivity and silent inactivation.
Inge M van der Sluis, Lynda M Vrooman, Rob Pieters...
https://pubmed.ncbi.nlm.nih.gov/26928249L-carnitine treatment reduces steatosis in patients with chronic hepatitis C treated with alpha-interferon and ribavirin.
Marcello Romano, Marco Vacante, Erika Cristaldi...
https://pubmed.ncbi.nlm.nih.gov/17939042Levocarnitine for asparaginase-induced hepatic injury: a multi-institutional case series and review of the literature.
Rachael R Schulte, Manasi V Madiwale, Allyson Flower...
https://pubmed.ncbi.nlm.nih.gov/29431566