RecruitingNot ApplicableNCT06233526

Individualized Treatment of Pediatric R/R AML Based on Transcriptomic Profile and in Vitro Drug Sensitivity Test

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

Sponsor

The Children's Hospital of Zhejiang University School of Medicine

Enrollment

60 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia in Children

Summary

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.

Eligibility

Max Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial offers personalized treatment for children under 18 with relapsed or treatment-resistant acute myeloid leukemia (AML) — a blood cancer — whose disease has not responded to second-line chemotherapy. It uses genetic analysis and lab tests on the child's own cancer cells to choose the best drug combination. **You may be eligible if...** - Your child is under 18 years old - Your child has AML that has come back or did not respond to second-line treatment - Your child is healthy enough to receive chemotherapy - You understand the study process and are willing to give written consent **You may NOT be eligible if...** - Your child has acute promyelocytic leukemia (APL) or certain other leukemia subtypes - Your child has Down syndrome, Fanconi anemia, or other related genetic conditions - Your child has HIV or significant heart or kidney problems - There is an active serious infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERChemotherapy regiments based on the transcriptomic profile and in vitro drug sensitivity test

1. Leukemia cells from newly diagnosed and relapsed children with AML were tested for high throughput in vitro drug sensitivity and resistance. 2. Combined with multi-omics sequencing technology such as whole exome and transcriptome, the data of drug sensitivity, drug resistance and genomic characteristics of children AML patients were integrated, and the internal rules between drug sensitivity or drug resistance and molecular characteristics such as gene fusion, gene mutation and abnormal gene expression of children AML patients were deeply analyzed, and the molecular characteristics of drug sensitivity in children AML were mapped