Personalized chemotherapy for children with relapsed or refractory acute myeloid leukemia

Individualized Treatment of Pediatric Relasped and Refractory Acute Myeloid Leukemia Based on Transcriptomic Profile and in Vitro Drug Sensitivity Test

This study is testing a personalized chemotherapy approach for children with relapsed or hard-to-treat acute myeloid leukemia to see if it can help them get better by using the most effective drugs for their specific needs.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: N/A to 18 Years
• Sex: All
• Sponsor: The Children's Hospital of Zhejiang University School of Medicine (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06233526 on ClinicalTrials.gov

What this trial studies

This study focuses on children with relapsed or refractory acute myeloid leukemia (AML) who have not achieved complete remission after standard treatments. It aims to develop individualized chemotherapy regimens based on each patient's transcriptomic profile and in vitro drug sensitivity tests. By identifying the most effective drugs for each child, the study seeks to improve treatment outcomes and reduce the high mortality rates associated with R/R AML. The approach is designed to create tailored treatment plans that maximize the chances of achieving remission.

Who should consider this trial

Good fit: Ideal candidates for this study are children under 18 years old with refractory recurrent acute myeloid leukemia who have not achieved complete remission after second-line reinduction therapy.

Not a fit: Patients with acute promyelocytic leukemia, chronic myelogenous leukemia, or those with significant organ dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly improve survival rates and treatment responses in children with relapsed or refractory AML.

How similar studies have performed: While the approach of using transcriptomic profiling and drug sensitivity testing is innovative, similar studies have shown promise in improving treatment outcomes for other cancers.

Eligibility criteria

Inclusion Criteria:

\- (1) Refractory recurrent acute myeloid leukemia (AML), and after second-line reinduction therapy, such as C+HAG did not reach complete CR.Criteria for complete response, refractory, and recurrence are as follows.

(2) \<18 years old; (3) The child had good organ function, could tolerate chemotherapy, and had a physical strength score of 0-3 (WHO standard); (4) Understand the research procedures and voluntarily sign written informed consent.

Exclusion Criteria:

\- (1) Acute promyelocytic leukemia, chronic myelogenous leukemia, acute mixed cell leukemia or known central nervous system leukemia; (2) AML associated with congenital syndromes such as Down syndrome, Fanconi anemia, Bloom syndrome, Cole's syndrome, or congenital aplastic anemia; (3) secondary to immunodeficiency or positive for human immunodeficiency virus (HIV); (4) Cardiac and renal function were obviously abnormal, and left ventricular ejection fraction was \<50%.

(5) There is active systemic infection; (6) any medical history or concomitant condition that the investigator believes would impair the subject's safe completion of the study; (7) The investigator considers that the subject is medically unfit to receive the investigational drug or is unfit for any other reason; (8) a known or suspected allergy to the subject drug or to any drug administered in connection with this test;

Where this trial is running

Hangzhou, Zhejiang

• Children's Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (RECRUITING)

Study contacts

• Principal investigator: Xiaojun Xu, MD — The Children's Hospital of Zhejiang University School of Medicine
• Study coordinator: Xiaojun Xu, MD

Conditions: Acute Myeloid Leukemia in Children, Acute myeloid leukemia, relapsed/refractory, transcriptomic sequencing, drug sensitivity test