Actively Recruiting
Individualized Treatment of Pediatric R/R AML 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
104 weeks
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) accounts for about 15% to 20% of childhood leukemia, but the death rate accounts for about 50%. About 20-30% of children with AML did not achieve complete response (CR) after 2 induction treatments, and about 30% of children with CR had relapse within 3 years (including recurrence after hematopoietic stem cell transplantation).Relapsed/refractory (R/R) AML is a major cause of treatment failure and refractory survival. Reinduction chemotherapy for R/R-AML to obtain CR again, followed by hematopoietic stem cell transplantation, is the current treatment. At present, there is no recognized reinduction protocol, and the reinduction remission rate of R/R-AML varies greatly among different treatment regimens, ranging from 23 to 81%. Current guidelines recommend a new combination chemotherapy regimen consisting of new drugs without cross-resistance. This method selects sensitive chemotherapeutic drugs, and then forms a new combination chemotherapy regimen according to the characteristics of drugs, which is the choice of R/R-AML reinduction therapy.This study intends to conduct a clinical study on the individualized treatment of R/R AML patients through in vitro drug sensitivity test combined with patient transcriptomic characteristics.
CONDITIONS
Official Title
Individualized Treatment of Pediatric R/R AML Based on Transcriptomic Profile and in Vitro Drug Sensitivity Test
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Refractory or recurrent acute myeloid leukemia (AML) not achieving complete remission after second-line reinduction therapy
- Patient younger than 18 years old
- Good organ function and able to tolerate chemotherapy
- Physical strength score of 0-3 based on WHO standard
- Understanding of research procedures and voluntary signed informed consent
You will not qualify if you...
- 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 human immunodeficiency virus (HIV)
- Significant cardiac or renal dysfunction with left ventricular ejection fraction below 50%
- Active systemic infection
- Any medical history or condition that impairs safe study completion as judged by investigator
- Medically unfit to receive investigational drug or for any other reason as judged by investigator
- Known or suspected allergy to study drugs or any drugs administered in connection with the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Children's Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
X
Xiaojun Xu, MD
CONTACT
M
Meidan Ying, PhD
CONTACT
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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