Trial Title:
A Study of Selinexor in Combination With Azacitidine and Venetoclax (SAV Regimen) in Treatment Naïve Participants With Acute Myeloid Leukemia
NCT ID:
NCT05736965
Condition:
AML, Adult
Conditions: Official terms:
Leukemia, Myeloid, Acute
Azacitidine
Venetoclax
Conditions: Keywords:
selinexor
untreated AML
azacitidine
venetoclax
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Selinexor
Description:
Selinexor 60mg, PO d3,10,17
Arm group label:
SAV arm
Other name:
xpo1 inhibitor
Intervention type:
Drug
Intervention name:
Azacitidine
Description:
Azacitidine 75mg/m2, IV d1-3, 8-9, 15-16
Arm group label:
SAV arm
Intervention type:
Drug
Intervention name:
Venetoclax
Description:
Venetoclax 100mg PO on day 1 and 200mg on day 2, 400mg on day 3-14
Arm group label:
SAV arm
Other name:
ABT199
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.
Detailed 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.
Selinexor will be given orally at 60mg, d3,10,17 Azacitidine will be given at 75mg/m2,
d1-3, 8-9, 15-16 Venetoclax will be given orally at 100mg on day 1 and 200mg on day 2,
400mg on day 3-14
28 days per cycle, patients can receive transplants at any time once they achieved
complete remission and other patients will continue to receive treatment until disease
progression or unacceptable toxic effects.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Jilin University China Japan Union Hospital
Address:
City:
Ch'ang-ch'un
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
yuansong bai
Facility:
Name:
Changzhou Municipal No.1 People's Hospital
Address:
City:
Changzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
weiying gu
Facility:
Name:
Sichuan Provincial People's Hospital
Address:
City:
Chengdu
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
hui li
Facility:
Name:
Harbin Institute of Hematology and Oncology
Address:
City:
Ha'erbin
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
hong liang
Facility:
Name:
Anhui Provincial Hospital
Address:
City:
Hefei
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
xiaoyu zhu
Facility:
Name:
the first hospital of Jiaxing affiliated hospital of Jiaxing University
Address:
City:
Jiaxing
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
hui zeng
Facility:
Name:
Gansu Provincial People's Hospital
Address:
City:
Lanzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
qike zhang
Facility:
Name:
Lanzhou University NO.2 Hospital
Address:
City:
Lanzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
pengyun zeng
Facility:
Name:
Ningbo Medical Center Lihuili Huspital
Address:
City:
Ningbo
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
jing le
Facility:
Name:
Shanghai Ruijin Hospital
Address:
City:
Shanghai
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Junmin Li
Facility:
Name:
Shanghai Tong Ren hospital
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Ligen Liu
Phone:
18017337037
Email:
llg3532@shtrhospital.com
Facility:
Name:
The First Hospital of China Medical University
Address:
City:
Shenyang
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
xiaojing yan
Facility:
Name:
The First Hospital of Hebei Medical University
Address:
City:
Shijia Zhuang
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
qingchi liu
Facility:
Name:
The Second Hospital of Hebei Medical University
Address:
City:
Shijia Zhuang
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
jinhai ren
Facility:
Name:
the Second Affiliated Hospital of Wannan Medical College
Address:
City:
Wuhu
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
dongping huang
Facility:
Name:
Xi'an International Medical Center
Address:
City:
Xi'an
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
yingmin liang
Facility:
Name:
Northern Jiangsu People's Hospital
Address:
City:
Yangzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
mei su
Facility:
Name:
Yixing People's Hospital
Address:
City:
Yixing
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
wenzhong wu
Facility:
Name:
First Affiliated Hospital of Xinjiang Medical University
Address:
City:
Ürümqi
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
ming jiang
Start date:
February 20, 2023
Completion date:
April 30, 2027
Lead sponsor:
Agency:
Shanghai Tong Ren Hospital
Agency class:
Other
Source:
Shanghai Tong Ren Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05736965
