Actively Recruiting
Clinical Efficacy and Safety of Adaptive Treatment of Acute Myeloid Leukemia Based on Day 14 MRD Results - A Multicenter, Single-Arm, Prospective Study
Led by Shanghai Tong Ren Hospital · Updated on 2023-03-15
58
Participants Needed
4
Research Sites
106 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying an adaptive treatment approach for adults with newly diagnosed acute myeloid leukemia (AML) who are not suitable for intensive chemotherapy. This phase 2, prospective, single-arm, multi-center clinical trial evaluates the safety and effectiveness of combining selinexor with azacitidine and venetoclax based on measurable residual disease (MRD) results taken on day 14 of the first treatment cycle. Participants receive azacitidine at 75 mg/m2 on days 1 through 7 and venetoclax starting at 100 mg on day 1, increasing to 200 mg on day 2 and 400 mg daily from days 3 to 28, in 28-day cycles. On cycle 1 day 14, MRD is assessed; patients who test negative continue azacitidine and venetoclax alone, while those who test positive add selinexor 60 mg on days 15 and 22. Patients may receive transplants once complete remission is achieved or continue treatment until disease progression or unacceptable side effects occur. During the study, participants undergo regular evaluations including MRD testing, survival assessments, and response monitoring for up to approximately four years. The primary outcome is the percentage of participants achieving composite complete remission within about two years. The study also monitors overall survival, overall response rate, MRD negativity rates, and recurrence-free survival. Treatment safety and tolerability are closely observed throughout the trial period.
CONDITIONS
Brief Title
Adaptive Treatment for Acute Myeloid Leukemia Based on D14 MRD Results
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide known and written informed consent voluntarily
- Age 18 years or older
- Newly diagnosed AML patients per WHO 2022 classification who are not suitable for intensive chemotherapy
- Age 75 years or older, or age 18 to 74 years with at least one comorbidity such as ECOG performance status 2-4, treated congestive heart failure, reduced ejection fraction (<= 50%), chronic stable angina, reduced lung function (DLCO <= 65% or FEV1 <= 65%), creatinine clearance between 30 and <45 mL/min, moderate hepatic impairment (bilirubin >1.5 to <=3.0 x ULN), or other physician-judged incompatibility with intensive chemotherapy
- Liver function with AST and ALT <= 3.0 x ULN and bilirubin <= 1.5 x ULN (bilirubin up to 3.0 x ULN allowed if under 75 years unless due to leukemic organ involvement)
- Renal function with creatinine clearance >= 30 mL/min (Cockroft-Gault formula)
- Life expectancy of 4 weeks or more
You will not qualify if you...
- History of prior malignancies except as noted in the protocol
- Known HIV infection, active hepatitis B or hepatitis C virus infection
- Active central nervous system involvement with AML
- 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 - Repeated 28-day cycles until disease progression or discontinuation
Participants receive azacitidine and venetoclax in 28-day cycles. On Day 14 of the first cycle, minimal residual disease (MRD) is assessed to adapt treatment: MRD negative participants continue azacitidine and venetoclax, while MRD positive participants receive added selinexor on Days 15 and 22. Treatment continues until disease progression or unacceptable toxic effects.
Visits occur throughout each 28-day treatment cycle, including Day 14 MRD assessment and selinexor dosing on Days 15 and 22 for some participants
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
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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