Clinical Application of Novel Panels for Early Precision Diagnosis and Relapse Prediction in High-risk Leukemia

Completed

• Conditions: Leukemia, Acute
• Interventions: Diagnostic Test: High-risk subtype detection panels

• Registration Number: NCT03297476
• Lead Sponsor: Zhongda Hospital

Brief Summary

Based on the investigator's previous data on risk classification for acute leukemia,the investigators will design a set of panels to detect the gene expression and genomic variants (SNPs, mutation, insertion, deletion and fusion genes, etc), and identify the high-risk subtypes of acute leukemia, such as Ph-like acute lymphoblastic leukemia. Furthermore, the target therapy (Tyrosine Kinase Inhibitors,et.al) will be used to treat the identified patients. In addition, more sensitive minimal residual disease (MRD) detection technology will be designed and used to detect the MRD in patients to early predict the disease relapse.

Detailed Description

patient eligibility criteria: newly diagnosed acute leukemia patients with clinical high-risk markers, reflactory and relapsed patients.

Study Timeline

• Study First Submitted: 2017-08-15
• Study First Submitted QC: 2017-09-28
• Study First Posted: 2017-09-29
• Study Start: 2017-12-01
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-23
• Last Update Posted: 2022-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Newly diagnostic acute lymphoblastic leukemia Be willing to start treatment

Exclusion Criteria

• chronic leukemia

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
high-risk group	High-risk subtype detection panels	Selected by "High-risk subtype detection panels"
non high-risk group	High-risk subtype detection panels	Selected by "High-risk subtype detection panels"

Primary Outcome Measures

Name	Time	Method
complete remission	From date of randomization or initial treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months	Patients achieve complete remission after initial treatment
relapse	From date of randomization or complete remission until the date of first documented relapse from any cause, whichever came first, assessed up to 100 weeks	Patients' disease progress after complete remission

Trial Locations

Locations (1)

Department of Hematology, Zhongda Hospital Southeast University, Institute of Hematology Southeast University; 🇨🇳 Nanjing, Jiangsu, China