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RECRUITING
NCT05736978
PHASE2

Adaptive Treatment for Acute Myeloid Leukemia Based on D14 MRD Results

Sponsor: Shanghai Tong Ren Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

58

Start Date

2023-03-31

Completion Date

2027-03-15

Last Updated

2023-03-15

Healthy Volunteers

No

Conditions

Interventions

DRUG

Azacitidine

75mg/m2 d1-7

DRUG

Venetoclax

d1 100mg, d2 200mg, d3-28 400mg

DRUG

Selinexor

if MRD positive in C1D14, selinexor 60mg D15, D22

Locations (4)

Beizhan Hospital

Shanghai, China

Pla Navy Feature Medical Center

Shanghai, China

Shanghai Ruijin Hospital

Shanghai, China

Shanghai Tong Ren hospital

Shanghai, China