CI

At a glance

ClinicalIndex Comparison Record
N/AUnknown· 1,000 target
Drug / intervention
Justified risk stratification based on MRD after three course chemo therapyother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03620955
NCT03620955N/AUnknown

Risk-stratified Therapy Based on Molecular and Cytogenetic Aberration and Treatment Response in Acute Myeloid Leukemia

Nanfang Hospital, Southern Medical University·observational·Posted Aug 8, 2018·Updated Nov 4, 2019

In Brief

An observational study evaluating Justified risk stratification based on MRD after three course chemo therapy for Risk-directed Therapy and 3 related conditions. Targeting 1,000 participants across 1 site.

Detailed Summary

Risk-stratified therapy based on molecular and cytogenetic for acute myeloid leukemia (AML) is well accepted and benefits patients' survival. However, neither every patient with low risk factors obtains better survival, nor all high risk patients experience worse outcome. Lots of data have shown that the early treatment response presenting as minimal residual disease (MRD) has an important role in prognostic prediction. In this study, we perform risk stratification based on not only Cytogenetic and Molecular characteristic, but also MRD after three courses of chemo therapy in AML cohort. Patients with MRD positive would be moved to a higher risk class. And then the risk-stratified therapy should be considered according to the new risk stratification.

Study Details

Timeline

N/AUnknownOverdue
20192020202120222023202420252026
First PostedAug 8, 2018
Enrollment StartAug 10, 2018
Primary CompletionDec 1, 2020
Study CompletionDec 1, 2021
TodayJul 1, 2026
Enrollment to primary: 2.3 yearsPosted 7.9 years ago

Interventions

Justified risk stratification based on MRD after three course chemo therapyother

All patients are routinely divided into different risk groups according to the NCCN guild based on cytogenetic and molecular abnormality. Then all patients are treated with anthracycline combined with cytarabine regimens for two courses . The patients without obtaining CR will go on one cycle of salvage therapy and then be bridged to allo-HSCT. Those acquiring CR will be given one more course of HDAC as consolidation treatment and then be detested MRD with flow cytometry after that. The patients with MRD positive would be moved to a higher risk class.The stratified therapy should be considered according to the new risk stratification.