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

Leukemia, Acute Clinical Trial

Official title:

Early Precision Diagnosis and Relapse Prediction Technology Development in High-risk Acute Leukemia and Clinical Application

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03297476
• Other study ID #: ZDYYGZ201708
• Status: Completed
• Start date: December 1, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2022
• Source: Zhongda Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 75 Years

Eligibility

Inclusion Criteria:

• Newly diagnostic acute lymphoblastic leukemia Be willing to start treatment

Exclusion Criteria:

• chronic leukemia

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Acute

Intervention

Diagnostic Test:
• High-risk subtype detection panels
The designed detection technology were used to identify the high-risk patients cohort.

Locations

Country	Name	City	State
China	Department of Hematology, Zhongda Hospital Southeast University, Institute of Hematology Southeast University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Zhongda Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete remission	Patients achieve complete remission after initial treatment	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
Primary	relapse	Patients' disease progress after complete remission	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