Actively Recruiting
Clinical Efficacy and Safety of Selinexor Combined With Azacitidine and Venetoclax in Treating Acute Myeloid Leukemia (AML) - Multi-center, Single-arm, Prospective Study
Led by Shanghai Tong Ren Hospital · Updated on 2023-03-15
58
Participants Needed
19
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and effectiveness of combining selinexor with azacitidine and venetoclax in adults newly diagnosed with acute myeloid leukemia (AML) who have not received prior treatment. The study is a prospective, single-arm, multi-center clinical trial focusing on patients who are either ineligible for or refuse intensive chemotherapy. It is designed to gather data on how well this combination works and its safety profile in this patient group. Participants will receive selinexor orally at 60 mg on days 3, 10, and 17; azacitidine intravenously at 75 mg/m2 on days 1-3, 8-9, and 15-16; and venetoclax orally starting at 100 mg on day 1, increasing to 200 mg on day 2, and 400 mg on days 3-14 within each 28-day treatment cycle. Those who achieve complete remission may undergo a transplant at any time, while others will continue treatment until the disease progresses or unacceptable side effects occur. During the study, participants will be closely monitored for treatment response and safety through assessments including remission rates up to about two years. Secondary measures include overall survival, response rates, minimal residual disease negativity, and recurrence-free survival over approximately four years. The total participation time varies based on individual outcomes, with ongoing evaluations to track effectiveness and side effects throughout the study period.
CONDITIONS
Brief 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...
- Age 18 years or older
- Newly diagnosed acute myeloid leukemia patients per WHO 2022 criteria
- Patients unsuitable for intensive chemotherapy due to age 75 or older, or aged 18 to 74 with specific comorbidities such as ECOG performance status 2-4, certain heart, lung, kidney, or liver conditions, or other physician-judged incompatibility
- Patients suitable for intensive chemotherapy but who refuse it
- Liver function with AST and ALT less than or equal to 3 times the upper limit of normal, bilirubin less than or equal to 1.5 times ULN (up to 3 times ULN if under 75 years), unless related to leukemia involvement
- Renal function with creatinine clearance greater than or equal to 30 mL/min
- Life expectancy of at least 4 weeks
- Provided known and written voluntary informed consent
You will not qualify if you...
- History of any previous malignancies except as noted in the protocol
- Known HIV infection or active hepatitis B or C virus infection
- Known active central nervous system involvement with acute myeloid leukemia
- Prior anti-AML treatment except hydroxyurea
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28-day cycles repeated until disease progression or unacceptable toxic effects
Participants receive selinexor, azacitidine, and venetoclax in 28-day cycles to treat acute myeloid leukemia. They may receive a transplant after achieving complete remission or continue treatment until disease progression or unacceptable side effects.
Visits occur throughout each 28-day cycle as participants take medications on specified days
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
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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