Back to resultsA Study of Selinexor in Combination With Azacitidine and Venetoclax (SAV Regimen) in Treatment Naïve Participants With Acute Myeloid Leukemia (SAV)
Primary Purpose
AML, Adult
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Selinexor
Azacitidine
Venetoclax
Sponsored by
About this trial
This is an interventional treatment trial for AML, Adult focused on measuring selinexor, untreated AML, azacitidine, venetoclax
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
Sites / Locations
- Jilin University China Japan Union Hospital
- Changzhou Municipal No.1 People's Hospital
- Sichuan Provincial People's Hospital
- Harbin Institute of Hematology and Oncology
- Anhui Provincial Hospital
- the first hospital of Jiaxing affiliated hospital of Jiaxing University
- Gansu Provincial People's Hospital
- Lanzhou University NO.2 Hospital
- Ningbo Medical Center Lihuili Huspital
- Shanghai Ruijin Hospital
- Shanghai Tong Ren hospitalRecruiting
- The First Hospital of China Medical University
- The First Hospital of Hebei Medical University
- The Second Hospital of Hebei Medical University
- the Second Affiliated Hospital of Wannan Medical College
- Xi'an International Medical Center
- Northern Jiangsu People's Hospital
- Yixing People's Hospital
- First Affiliated Hospital of Xinjiang Medical University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SAV arm
Arm Description
Untreated acute myeloid leukemia who are ineligible for intensive chemotherapy or who refuse to receive intensive chemotherapy will receive selinexor in combination with azacitidine and venetoclax, 28 days per cycle, patients can receive transplants at any time once they achieved complete remission and other patients will continue to receive SAV regimen until disease progression or unacceptable toxic effects.
Outcomes
Primary Outcome Measures
Percentage of Participants With Composite Complete Remission
composite complete remission(CR , CRh, CRi) was calculated based on ELN2022 criteria.
Secondary Outcome Measures
overall survival (OS)
Overall response rate(ORR)
percentage of patients who achieved MRD negativity
Recurrence Free Survival(RFS)
Full Information
NCT ID
NCT05736965
First Posted
February 12, 2023
Last Updated
March 13, 2023
Sponsor
Shanghai Tong Ren Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05736965
Brief Title
A Study of Selinexor in Combination With Azacitidine and Venetoclax (SAV Regimen) in Treatment Naïve Participants With Acute Myeloid Leukemia
Acronym
SAV
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 20, 2023 (Actual)
Primary Completion Date
March 30, 2025 (Anticipated)
Study Completion Date
April 30, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Tong Ren Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
AML, Adult
Keywords
selinexor, untreated AML, azacitidine, venetoclax
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
58 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SAV arm
Arm Type
Experimental
Arm Description
Untreated acute myeloid leukemia who are ineligible for intensive chemotherapy or who refuse to receive intensive chemotherapy will receive selinexor in combination with azacitidine and venetoclax, 28 days per cycle, patients can receive transplants at any time once they achieved complete remission and other patients will continue to receive SAV regimen until disease progression or unacceptable toxic effects.
Intervention Type
Drug
Intervention Name(s)
Selinexor
Other Intervention Name(s)
xpo1 inhibitor
Intervention Description
Selinexor 60mg, PO d3,10,17
Intervention Type
Drug
Intervention Name(s)
Azacitidine
Intervention Description
Azacitidine 75mg/m2, IV d1-3, 8-9, 15-16
Intervention Type
Drug
Intervention Name(s)
Venetoclax
Other Intervention Name(s)
ABT199
Intervention Description
Venetoclax 100mg PO on day 1 and 200mg on day 2, 400mg on day 3-14
Primary Outcome Measure Information:
Title
Percentage of Participants With Composite Complete Remission
Description
composite complete remission(CR , CRh, CRi) was calculated based on ELN2022 criteria.
Time Frame
From the study start up to death (up to approximately 2 years; )
Secondary Outcome Measure Information:
Title
overall survival (OS)
Time Frame
From the study start up to death (up to approximately 4 years; )
Title
Overall response rate(ORR)
Time Frame
From the study start up to death (up to approximately 4 years; )
Title
percentage of patients who achieved MRD negativity
Time Frame
From the study start up to death (up to approximately 4 years; )
Title
Recurrence Free Survival(RFS)
Time Frame
From the study start up to death (up to approximately 4 years; )
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ligen Liu, MD
Phone
18017337037
Email
llg3532@shtrhospital.com
Facility Information:
Facility Name
Jilin University China Japan Union Hospital
City
Ch'ang-ch'un
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yuansong bai
Facility Name
Changzhou Municipal No.1 People's Hospital
City
Changzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
weiying gu
Facility Name
Sichuan Provincial People's Hospital
City
Chengdu
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
hui li
Facility Name
Harbin Institute of Hematology and Oncology
City
Ha'erbin
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
hong liang
Facility Name
Anhui Provincial Hospital
City
Hefei
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xiaoyu zhu
Facility Name
the first hospital of Jiaxing affiliated hospital of Jiaxing University
City
Jiaxing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
hui zeng
Facility Name
Gansu Provincial People's Hospital
City
Lanzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
qike zhang
Facility Name
Lanzhou University NO.2 Hospital
City
Lanzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
pengyun zeng
Facility Name
Ningbo Medical Center Lihuili Huspital
City
Ningbo
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jing le
Facility Name
Shanghai Ruijin Hospital
City
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junmin Li
Facility Name
Shanghai Tong Ren hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ligen Liu
Phone
18017337037
Email
llg3532@shtrhospital.com
Facility Name
The First Hospital of China Medical University
City
Shenyang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xiaojing yan
Facility Name
The First Hospital of Hebei Medical University
City
Shijia Zhuang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
qingchi liu
Facility Name
The Second Hospital of Hebei Medical University
City
Shijia Zhuang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jinhai ren
Facility Name
the Second Affiliated Hospital of Wannan Medical College
City
Wuhu
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
dongping huang
Facility Name
Xi'an International Medical Center
City
Xi'an
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yingmin liang
Facility Name
Northern Jiangsu People's Hospital
City
Yangzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mei su
Facility Name
Yixing People's Hospital
City
Yixing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
wenzhong wu
Facility Name
First Affiliated Hospital of Xinjiang Medical University
City
Ürümqi
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ming jiang
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of Selinexor in Combination With Azacitidine and Venetoclax (SAV Regimen) in Treatment Naïve Participants With Acute Myeloid Leukemia
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