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

Launched by THE CHILDREN'S HOSPITAL OF ZHEJIANG UNIVERSITY SCHOOL OF MEDICINE · Jan 23, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to treat children with a type of cancer called relapsed or refractory acute myeloid leukemia (R/R AML). This means the cancer has either come back after treatment or did not respond to previous treatments. The goal of the study is to personalize treatment based on specific tests that show how the cancer cells react to different drugs. By doing this, doctors hope to find the most effective combination of medications that will help the child achieve a complete response, which means no signs of cancer after treatment.

To be eligible for this trial, children must be under 18 years old and have R/R AML that has not responded to earlier treatments. They should also be in good health and able to handle chemotherapy. Participants will undergo tests to determine which drugs might work best for them, and then they will receive a tailored treatment plan based on these results. It’s important to note that this trial is currently recruiting participants, and it aims to provide a more effective and personalized approach to treating this challenging condition in children.

Gender

ALL

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;