Advances in acute myeloid leukemia.
Laura F Newell, Rachel J Cook
https://pubmed.ncbi.nlm.nih.gov/34615640Actively Recruiting
Phase Not Applicable
Age: 0 - 18Years
All Genders
Healthy Volunteers
ID06233526
Individualized Treatment of Pediatric Relapsed and Refractory Acute Myeloid Leukemia Based on Transcriptomic Profile and In Vitro Drug Sensitivity Test
Led by The Children's Hospital of Zhejiang University School of Medicine · Updated on 2024-07-03
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
T
The Children's Hospital of Zhejiang University School of Medicine
Lead Sponsor
C
College of Pharmaceutical Science at Zhejiang University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Acute myeloid leukemia (AML) in children represents about 15% to 20% of childhood leukemia cases, with a high death rate around 50%. Many children with AML either do not achieve complete response after standard treatments or experience relapse within three years, making relapsed or refractory AML a major challenge. This trial studies individualized treatment plans for children with relapsed or refractory AML by combining drug sensitivity testing and transcriptomic profiling to guide therapy choices. The study evaluates chemotherapy regimens tailored to each patient's AML characteristics based on in vitro drug sensitivity tests and their molecular profiles obtained from whole exome and transcriptome sequencing. This approach integrates data on drug sensitivity, resistance, and genetic features to develop personalized treatment strategies without cross-resistance to improve reinduction therapy outcomes. Participants will undergo testing of their leukemia cells, and treatment will be adjusted accordingly. Researchers will monitor outcomes including complete remission rate at 4 weeks and event-free survival at one and five years. Additional assessments include overall survival rates. The trial focuses on children under 18 years with relapsed or refractory AML who can tolerate chemotherapy. The study is sponsored by The Children's Hospital of Zhejiang University School of Medicine and is expected to continue until the end of 2025.
CONDITIONS
Brief Title
Individualized Treatment of Pediatric R/R AML Based on Transcriptomic Profile and in Vitro Drug Sensitivity Test
Who Can Participate
Age: 0 - 18Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Diagnosis of refractory or relapsed acute myeloid leukemia (AML) not reaching complete remission after second-line reinduction therapy
- Younger than 18 years old
- Good organ function and able to tolerate chemotherapy
- Physical strength score of 0-3 according to WHO standard
- Understands the study procedures and has signed informed consent
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia, chronic myelogenous leukemia, acute mixed cell leukemia, or known central nervous system leukemia
- AML associated with congenital syndromes such as Down syndrome, Fanconi anemia, Bloom syndrome, Cole's syndrome, or congenital aplastic anemia
- Immunodeficiency or positive for HIV
- Abnormal cardiac or renal function, including left ventricular ejection fraction below 50%
- Active systemic infection
- Any medical history or condition that may impair safe completion of the study
- Medically unfit to receive study treatment
- Known or suspected allergy to the study drugs or related medications
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 - Up to 4 weeks
Participants receive chemotherapy regimens individualized based on their transcriptomic profile and in vitro drug sensitivity test results.
Multiple visits for chemotherapy administration and monitoring
Follow-up
Duration - Up to 5 years
Participants are monitored for event-free survival and overall survival up to five years after treatment.
Periodic visits for survival and health status assessments
Trial Site Locations
Total: 1 location
1
Children's Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
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Research Team
X
Xiaojun Xu, MD
M
Meidan Ying, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Treatments for children and adolescents with AML.
Hyery Kim
https://pubmed.ncbi.nlm.nih.gov/32719170Relapsed acute myeloid leukemia in children and adolescents: current treatment options and future strategies.
Sara Zarnegar-Lumley, Kenneth J Caldwell, Jeffrey E Rubnitz
https://pubmed.ncbi.nlm.nih.gov/35668109[Chinese guidelines for the diagnosis and treatment of relapsed/refractory acute myelogenous leukemia (2021)].
Leukemia & Lymphoma Group, Chinese Society of Hematology, Chinese Medical Association
https://pubmed.ncbi.nlm.nih.gov/34547866Proteasome inhibition targets the KMT2A transcriptional complex in acute lymphoblastic leukemia.
Jennifer L Kamens, Stephanie Nance, Cary Koss...
https://pubmed.ncbi.nlm.nih.gov/36781850A novel gene fusion RUNX1/ZNF423 promotes leukemic relapse of NUP98-rearranged AML.
Wenxin Du, Zhimei Xia, Zebin Luo...
https://pubmed.ncbi.nlm.nih.gov/37714925