Selinexor added to azacitidine and venetoclax for newly diagnosed acute myeloid leukemia
Tests selinexor with azacitidine and venetoclax in adults with untreated acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: A Study of Selinexor in Combination With Azacitidine and Venetoclax (SAV Regimen) in Treatment Naïve Participants With Acute Myeloid Leukemia
Key facts
- Where
- Ch’ang-ch’un, Changzhou, Chengdu, Ha’erbin, Hefei, Jiaxing, Lanzhou, Ningbo, Shanghai, Shenyang, Shijia Zhuang, Ürümqi, Wuhu, Xi'an, Yangzhou, and Yixing, ChinaSee the 19 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 have not had treatment and cannot have, or refuse, intensive chemotherapy.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Newly diagnosed AML (WHO 2022 criteria). People aged 75 or older, or aged 18 to 74 with a health problem that rules out intensive chemotherapy, or people who refuse intensive chemotherapy.
- Earlier treatment
- No earlier treatment for AML, except hydroxyurea.
Main reasons for not taking part
- Another cancer in the past, apart from exceptions named in the protocol
- Known HIV infection, active hepatitis B or hepatitis C
- Known active AML in the brain or spinal cord (central nervous system)
- Earlier AML treatment other than hydroxyurea
Read by machine on 12 November 2026.
Where in China
- Jilin University China Japan Union HospitalCh’ang-ch’un, ChinaContact: yuansong baiNot yet recruiting
- Changzhou Municipal No.1 People's HospitalChangzhou, ChinaContact: weiying guNot yet recruiting
- Sichuan Provincial People's HospitalChengdu, ChinaContact: hui liNot yet recruiting
- Harbin Institute of Hematology and OncologyHa’erbin, ChinaContact: hong liangNot yet recruiting
- Anhui Provincial HospitalHefei, ChinaContact: xiaoyu zhuNot yet recruiting
- the first hospital of Jiaxing affiliated hospital of Jiaxing UniversityJiaxing, ChinaContact: hui zengNot yet recruiting
- Gansu Provincial People's HospitalLanzhou, ChinaContact: qike zhangNot yet recruiting
- Lanzhou University NO.2 HospitalLanzhou, ChinaContact: pengyun zengNot yet recruiting
- Ningbo Medical Center Lihuili HuspitalNingbo, ChinaContact: jing leNot yet recruiting
- Shanghai Ruijin HospitalShanghai, ChinaContact: Junmin LiNot yet recruiting
- Shanghai Tong Ren hospitalShanghai, ChinaContact: Ligen LiuTaking people
- The First Hospital of China Medical UniversityShenyang, ChinaContact: xiaojing yanNot yet recruiting
- the First Hospital of Hebei Medical UniversityShijia Zhuang, ChinaContact: qingchi liuNot yet recruiting
- The Second Hospital of Hebei Medical UniversityShijia Zhuang, ChinaContact: jinhai renNot yet recruiting
- First Affiliated Hospital of Xinjiang Medical UniversityÜrümqi, ChinaContact: ming jiangNot yet recruiting
- the Second Affiliated Hospital of Wannan Medical CollegeWuhu, ChinaContact: dongping huangNot yet recruiting
- Xi'an International Medical CenterXi'an, ChinaContact: yingmin liangNot yet recruiting
- Northern Jiangsu People's HospitalYangzhou, ChinaContact: mei suNot yet recruiting
- Yixing People's HospitalYixing, ChinaContact: wenzhong wuNot yet recruiting
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
- NCT05736965
- 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.Read full original descriptionShow less
Clinical Efficacy and Safety of Selinexol Combined With Azacitidine and Venetoclax (SAV Regimen) in the Treatment of Acute Myeloid Leukemia (AML)-a Multi-center, 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.
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 ; 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: 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.