Actively Recruiting
A Study of Selinexor in Combination With Azacitidine and Venetoclax (SAV Regimen) in Treatment Naïve Participants With Acute Myeloid Leukemia
Led by Shanghai Tong Ren Hospital · Updated on 2023-03-15
58
Participants Needed
19
Research Sites
218 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Selinexor in Combination With Azacitidine and Venetoclax (SAV Regimen) in Treatment Naïve Participants With Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent
- Age 18 years or older
- Newly diagnosed with AML according to WHO 2022 criteria and not suitable for intensive chemotherapy due to age (75 or older) or certain health conditions
- Patients aged 18 to 74 with at least one of these: ECOG score 2-4, heart failure or angina, reduced lung function, moderate kidney impairment, moderate liver impairment, or other physician-assessed comorbidity
- Patients suitable for intensive chemotherapy who refuse it
- Liver function with AST and ALT less than or equal to 3 times upper normal limit; bilirubin less than or equal to 1.5 times upper normal limit (up to 3 times if under 75 years old), unless due to leukemia involvement
- Kidney function with creatinine clearance 30 mL/min or higher
- Life expectancy of 4 weeks or more
You will not qualify if you...
- History of any other cancers before joining the study, except as noted in the protocol
- Known HIV infection or active hepatitis B or C virus infection
- Known active involvement of AML in the central nervous system
- Prior treatment for AML other than hydroxyurea
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
Changzhou Municipal No.1 People's Hospital
Changzhou, China
Not Yet Recruiting
2
Sichuan Provincial People's Hospital
Chengdu, China
Not Yet Recruiting
3
Jilin University China Japan Union Hospital
Ch’ang-ch’un, China
Not Yet Recruiting
4
Harbin Institute of Hematology and Oncology
Ha’erbin, China
Not Yet Recruiting
5
Anhui Provincial Hospital
Hefei, China
Not Yet Recruiting
6
the first hospital of Jiaxing affiliated hospital of Jiaxing University
Jiaxing, China
Not Yet Recruiting
7
Gansu Provincial People's Hospital
Lanzhou, China
Not Yet Recruiting
8
Lanzhou University NO.2 Hospital
Lanzhou, China
Not Yet Recruiting
9
Ningbo Medical Center Lihuili Huspital
Ningbo, China
Not Yet Recruiting
10
Shanghai Ruijin Hospital
Shanghai, China
Not Yet Recruiting
11
Shanghai Tong Ren hospital
Shanghai, China
Actively Recruiting
12
The First Hospital of China Medical University
Shenyang, China
Not Yet Recruiting
13
The First Hospital of Hebei Medical University
Shijia Zhuang, China
Not Yet Recruiting
14
The Second Hospital of Hebei Medical University
Shijia Zhuang, China
Not Yet Recruiting
15
First Affiliated Hospital of Xinjiang Medical University
Ürümqi, China
Not Yet Recruiting
16
the Second Affiliated Hospital of Wannan Medical College
Wuhu, China
Not Yet Recruiting
17
Xi'an International Medical Center
Xi'an, China
Not Yet Recruiting
18
Northern Jiangsu People's Hospital
Yangzhou, China
Not Yet Recruiting
19
Yixing People's Hospital
Yixing, China
Not Yet Recruiting
Research Team
L
Ligen Liu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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