A Study of Selinexor in Combination With Azacitidine and Venetoclax (SAV Regimen) in Treatment Naïve Participants With Acute Myeloid Leukemia
SAV
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
1 other identifier
interventional
58
1 country
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2023
Typical duration for phase_2
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2023
CompletedStudy Start
First participant enrolled
February 20, 2023
CompletedFirst Posted
Study publicly available on registry
February 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2027
ExpectedMarch 15, 2023
March 1, 2023
2.1 years
February 12, 2023
March 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Composite Complete Remission
composite complete remission(CR , CRh, CRi) was calculated based on ELN2022 criteria.
From the study start up to death (up to approximately 2 years; )
Secondary Outcomes (4)
overall survival (OS)
From the study start up to death (up to approximately 4 years; )
Overall response rate(ORR)
From the study start up to death (up to approximately 4 years; )
percentage of patients who achieved MRD negativity
From the study start up to death (up to approximately 4 years; )
Recurrence Free Survival(RFS)
From the study start up to death (up to approximately 4 years; )
Study Arms (1)
SAV arm
EXPERIMENTALUntreated 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.
Interventions
Venetoclax 100mg PO on day 1 and 200mg on day 2, 400mg on day 3-14
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Changzhou Municipal No.1 People's Hospital
Changzhou, China
Sichuan Provincial People's Hospital
Chengdu, China
Jilin University China Japan Union Hospital
Ch’ang-ch’un, China
Harbin Institute of Hematology and Oncology
Ha’erbin, China
Anhui Provincial Hospital
Hefei, China
the first hospital of Jiaxing affiliated hospital of Jiaxing University
Jiaxing, China
Gansu Provincial People's Hospital
Lanzhou, China
Lanzhou University NO.2 Hospital
Lanzhou, China
Ningbo Medical Center Lihuili Huspital
Ningbo, China
Shanghai Ruijin Hospital
Shanghai, China
Shanghai Tong Ren hospital
Shanghai, China
The First Hospital of China Medical University
Shenyang, China
The First Hospital of Hebei Medical University
Shijia Zhuang, China
The Second Hospital of Hebei Medical University
Shijia Zhuang, China
First Affiliated Hospital of Xinjiang Medical University
Ürümqi, China
the Second Affiliated Hospital of Wannan Medical College
Wuhu, China
Xi'an International Medical Center
Xi'an, China
Northern Jiangsu People's Hospital
Yangzhou, China
Yixing People's Hospital
Yixing, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
February 12, 2023
First Posted
February 21, 2023
Study Start
February 20, 2023
Primary Completion
March 30, 2025
Study Completion (Estimated)
April 30, 2027
Last Updated
March 15, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share