🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT05736965
Recruiting Phase 2

A Study of Selinexor in Combination With Azacitidine and Venetoclax (SAV Regimen) in Treatment Naïve Participants With Acute Myeloid Leukemia

NCT05736965 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Tong Ren Hospital
Phase
Phase 2
Started
2023-02-20
Last updated
2023-03-15

Condition(s) studied

AML, Adult

Investigational drug(s) / intervention(s)

SelinexorAzacitidineVenetoclax

Selinexor: Selinexor 60mg, PO d3,10,17

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)

Trial sites (19)

FacilityCityRegionStatus
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 Wuhu China Not Yet Recruiting
Xi'an International Medical Center Xi'an China Not Yet Recruiting
Northern Jiangsu People's Hospital Yangzhou China Not Yet Recruiting
Yixing People's Hospital Yixing China Not Yet Recruiting

On this site

📄 Venclexta (venetoclax) drug profile →

More Shanghai Tong Ren Hospital trials in China

Other trials for the same condition

Official registry record

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.

View NCT05736965 on ClinicalTrials.gov ↗ ← All trials in China