RecruitingPhase 2NCT05736965

A Study of Selinexor in Combination With Azacitidine and Venetoclax (SAV Regimen) in Treatment Naïve Participants With Acute Myeloid Leukemia

Clinical Efficacy and Safety of Selinexol Combined With Azacitidine and Venetoclax (SAV Regimen) in the Treatment of Acute Myeloid Leukemia (AML)-a Multi-center, Single-arm, Prospective Clinical Study


Sponsor

Shanghai Tong Ren Hospital

Enrollment

58 participants

Start Date

Feb 20, 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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a three-drug combination — selinexor, azacitidine, and venetoclax (called the SAV regimen) — in older or frail patients with newly diagnosed acute myeloid leukaemia (AML) who are not fit enough to tolerate intensive chemotherapy. All three drugs target different mechanisms that keep leukaemia cells alive. The study aims to find the safest effective dose and assess how well this combination works. **You may be eligible if...** - You are 75 years or older, OR you are 18–74 with significant health conditions (such as heart failure, poor lung function, reduced kidney function, or liver impairment) that make intensive chemotherapy too risky - You have been newly diagnosed with AML (or are fit enough for intensive chemo but prefer not to receive it) - 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 that has spread to the brain or spinal fluid - You have previously received any treatment for AML (except hydroxyurea to lower white cell count) - You have another active cancer - You have known 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.

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Interventions

DRUGSelinexor

Selinexor 60mg, PO d3,10,17

DRUGAzacitidine

Azacitidine 75mg/m2, IV d1-3, 8-9, 15-16

DRUGVenetoclax

Venetoclax 100mg PO on day 1 and 200mg on day 2, 400mg on day 3-14


Locations(19)

Changzhou Municipal No.1 People's Hospital

Changzhou, China

Sichuan Provincial People's Hospital

Chengdu, China

Jilin University China Japan Union Hospital

Ch’ang-ch’un, China

Harbin Institute of Hematology and Oncology

Ha’erbin, China

Anhui Provincial Hospital

Hefei, China

the first hospital of Jiaxing affiliated hospital of Jiaxing University

Jiaxing, China

Gansu Provincial People's Hospital

Lanzhou, China

Lanzhou University NO.2 Hospital

Lanzhou, China

Ningbo Medical Center Lihuili Huspital

Ningbo, China

Shanghai Ruijin Hospital

Shanghai, China

Shanghai Tong Ren hospital

Shanghai, China

The First Hospital of China Medical University

Shenyang, China

The First Hospital of Hebei Medical University

Shijia Zhuang, China

The Second Hospital of Hebei Medical University

Shijia Zhuang, China

First Affiliated Hospital of Xinjiang Medical University

Ürümqi, China

the Second Affiliated Hospital of Wannan Medical College

Wuhu, China

Xi'an International Medical Center

Xi'an, China

Northern Jiangsu People's Hospital

Yangzhou, China

Yixing People's Hospital

Yixing, China

View Full Details on ClinicalTrials.gov

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NCT05736965


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