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Adaptive Treatment for Acute Myeloid Leukemia Based on D14 MRD Results — AVS  

AML Clinical Trial

Official title:
Clinical Efficacy and Safety of Adaptive Treatment of Acute Myeloid Leukemia (AML) Based on D14 MRD results-a Multicenter, Single-arm, Prospective Clinical Study

Clinical Trial Summary

This is a prospective, single-arm, multi-center clinical trial to evaluate the efficacy and safety of selinexor in combination with azacitidine and venetoclax for untreated acute myeloid leukemia based on MRD results on day 14 of the first cycle.

Clinical Trial Description

Azacitidine and Venetoclax will be given at the approved dose regimen for 75mg/m2, d1-7(azacitidine) and 100mg on day 1 and 200mg on day 2, 400mg on day 3-28 (venetoclax), 28 days per cycle. Based on MRD results on C1D14, MRD negative patients will go on azacitidine and venetoclax regimen and for patients with MRD positive, selinexor 60mg on D15 and D22 will be added. Patients can receive transplants at any time once they achieved complete remission and other patients will continue to receive treatment until disease progression or unacceptable toxic effects. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05736978
Study type Interventional
Source Shanghai Tong Ren Hospital
Contact Ligen Liu, MD
Phone 18017337037
Email liuligen@shsmu.edu.cn
Status Recruiting
Phase Phase 2
Start date March 31, 2023
Completion date March 15, 2027
View Details
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