Azacitidine: Azacitidine 75mg/m2, IV d1-3, 8-9, 15-16
Venetoclax: Venetoclax 100mg PO on day 1 and 200mg on day 2, 400mg on day 3-14
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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 .
* patients who are suitable for intensive chemotherapy but refuse it
* 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 Criteria:
* History of any malignancies prior to study entry with exception noted in the protocol.
* 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.
* Must not have received prior anti-AML treatment except for hydroxyurea
Primary outcome measure(s)
Percentage of Participants With Composite Complete Remission — From the study start up to death (up to approximately 2 years; ) composite complete remission(CR , CRh, CRi) was calculated based on ELN2022 criteria.
Trial sites (19)
Facility
City
Region
Status
Changzhou Municipal No.1 People's Hospital
Changzhou
China
Not Yet Recruiting
Sichuan Provincial People's Hospital
Chengdu
China
Not Yet Recruiting
Jilin University China Japan Union Hospital
Ch’ang-ch’un
China
Not Yet Recruiting
Harbin Institute of Hematology and Oncology
Ha’erbin
China
Not Yet Recruiting
Anhui Provincial Hospital
Hefei
China
Not Yet Recruiting
the first hospital of Jiaxing affiliated hospital of Jiaxing University
Jiaxing
China
Not Yet Recruiting
Gansu Provincial People's Hospital
Lanzhou
China
Not Yet Recruiting
Lanzhou University NO.2 Hospital
Lanzhou
China
Not Yet Recruiting
Ningbo Medical Center Lihuili Huspital
Ningbo
China
Not Yet Recruiting
Shanghai Ruijin Hospital
Shanghai
China
Not Yet Recruiting
Shanghai Tong Ren hospital
Shanghai
China
Recruiting
The First Hospital of China Medical University
Shenyang
China
Not Yet Recruiting
The First Hospital of Hebei Medical University
Shijia Zhuang
China
Not Yet Recruiting
The Second Hospital of Hebei Medical University
Shijia Zhuang
China
Not Yet Recruiting
First Affiliated Hospital of Xinjiang Medical University
Ürümqi
China
Not Yet Recruiting
the Second Affiliated Hospital of Wannan Medical College
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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