Adjusts acute myeloid leukemia treatment using early MRD results
Tests selinexor with azacitidine and venetoclax in adults newly diagnosed with acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: Adaptive Treatment for Acute Myeloid Leukemia Based on D14 MRD Results
Key facts
- Where
- Shanghai, ChinaSee the 4 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with newly diagnosed acute myeloid leukemia (AML) who cannot have intensive chemotherapy. It tests selinexor with azacitidine and venetoclax.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Newly diagnosed AML (WHO 2022 classification). People aged 75 years or older, or aged 18 to 74 years with at least one other health problem, such as ECOG performance status 2, 3 or 4, heart failure, or reduced lung or kidney function. These are people who cannot have intensive chemotherapy.
- Earlier treatment
- No earlier treatment for AML, except hydroxyurea
Main reasons for not taking part
- Any other cancer in the past (with exceptions set in the protocol)
- Known HIV infection, active hepatitis B or hepatitis C
- Known active leukemia in the brain or spinal cord (central nervous system)
- Liver or kidney function below the limits set in the protocol
- Life expectancy under 4 weeks
Read by machine on 12 November 2026.
Where in China
- Beizhan HospitalShanghai, ChinaContact: Jie HaoNot yet recruiting
- Pla Navy Feature Medical CenterShanghai, ChinaContact: Rong LiNot yet recruiting
- Shanghai Ruijin HospitalShanghai, ChinaContact: Junmin LiNot yet recruiting
- Shanghai Tong Ren hospitalShanghai, ChinaContact: Ligen LiuTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Shanghai Tong Ren Hospital
- Trial code
- NCT05736978
- Record updated
- 15 March 2023
- Original description
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.Read full original descriptionShow less
Clinical Efficacy and Safety of Adaptive Treatment of Acute Myeloid Leukemia (AML) Based on D14 MRD results-a Multicenter, Single-arm, Prospective Clinical Study
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.
Inclusion: Known and written informed consent voluntarily; Age ≥ 18 years; Newly diagnosed AML patients (per WHO 2022 classification criteria for AML diagnosis), who are not suitable for intensive chemotherapy:; 75 years or Aged 18 to 74 years with at least one of the following comorbidities: Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or 3 or 4; Cardiac history of Congestive Heart Failure (CHF) requiring treatment or Ejection Fraction <= 50% or chronic stable angina; Diffusing capacity of the Lung for Carbon Monoxide (DLCO) <= 65% or Forced Expiratory Volume in 1 second (FEV1) <= 65%; Creatinine clearance >= 30 mL/min to < 45 ml/min; Moderate hepatic impairment with total bilirubin > 1.5 to <= 3.0 × Upper Limit of Normal (ULN); Any other comorbidity that the physician judges to be incompatible with intensive chemotherapy ; Liver function meets the following criteria: aspartate aminotransferase (AST) ≤ 3.0×ULN*; alanine aminotransferase (ALT) ≤3.0×ULN*; Bilirubin≤1.5×ULN*; For subjects <75 years old, the bilirubin level can be ≤3.0×ULN; Unless due to leukemic organ involvement; Renal function meets the following criteria: creatinine clearance ≥ 30 mL/min (Cockroft-Gault formula); Life expectancy ≥ 4 weeks.
Exclusion: History of any malignancies prior to study entry with exception noted in the protocol; Must not have received prior anti-AML treatment except for hydroxyurea; Participant has known HIV infection, active hepatitis B virus (HBV) and/or hepatitis C virus (HCV) ; Participant has known active central nervous system (CNS) involvement with AML.