RecruitingPhase 2NCT05736978

Adaptive Treatment for Acute Myeloid Leukemia Based on D14 MRD Results

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


Sponsor

Shanghai Tong Ren Hospital

Enrollment

58 participants

Start Date

Mar 31, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial uses early treatment response — measured 14 days into therapy — to personalise and adapt subsequent treatment in older or frail patients with newly diagnosed acute myeloid leukaemia (AML) who cannot tolerate intensive chemotherapy. By checking how much leukaemia remains (called MRD — measurable residual disease) at day 14, doctors can decide whether to escalate or change treatment to improve outcomes. **You may be eligible if...** - You are 75 or older, OR you are 18–74 with health conditions that make intensive chemotherapy too risky (such as heart failure, poor lung function, reduced kidney function, or other serious comorbidities) - You have been newly diagnosed with AML - Your liver and kidney function meet minimum thresholds - You are expected to live at least 4 weeks **You may NOT be eligible if...** - You have AML in the brain or spinal fluid - You have received any prior AML treatment (other than hydroxyurea to control white cell count) - You have another active cancer - You have HIV, active hepatitis B, or active hepatitis C Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGAzacitidine

75mg/m2 d1-7

DRUGVenetoclax

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

DRUGSelinexor

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05736978


Related Trials