Actively Recruiting
Adaptive Treatment for Acute Myeloid Leukemia Based on D14 MRD Results
Led by Shanghai Tong Ren Hospital · Updated on 2023-03-15
58
Participants Needed
4
Research Sites
206 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 based on MRD results on day 14 of the first cycle.
CONDITIONS
Official Title
Adaptive Treatment for Acute Myeloid Leukemia Based on D14 MRD Results
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided known and written informed consent voluntarily
- Aged 18 years or older
- Newly diagnosed with AML according to WHO 2022 criteria and not suitable for intensive chemotherapy
- Age 75 years or older, or aged 18 to 74 with at least one comorbidity such as ECOG score 2-4, heart failure needing treatment, low heart ejection fraction (<=50%), chronic stable angina, reduced lung function (DLCO or FEV1 <=65%), creatinine clearance between 30 and less than 45 mL/min, moderate liver impairment (bilirubin >1.5 to <=3.0 times upper limit of normal), or other physician-judged comorbidities incompatible with intensive chemotherapy
- Liver function: AST and ALT less than or equal to 3 times upper limit of normal, bilirubin less than or equal to 1.5 times upper limit of normal (or up to 3 times for patients under 75 unless caused by leukemic organ involvement)
- Renal function with creatinine clearance of 30 mL/min or higher
- Life expectancy of at least 4 weeks
You will not qualify if you...
- History of any malignancies before study entry except as noted in the protocol
- Known HIV infection, active hepatitis B or hepatitis C infection
- Known active involvement of the central nervous system with AML
- Received prior anti-AML treatment except for hydroxyurea
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Beizhan Hospital
Shanghai, China
Not Yet Recruiting
2
Pla Navy Feature Medical Center
Shanghai, China
Not Yet Recruiting
3
Shanghai Ruijin Hospital
Shanghai, China
Not Yet Recruiting
4
Shanghai Tong Ren hospital
Shanghai, China
Actively 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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here