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

March 13, 2023 updated by: Liu Ligen, Shanghai Tong Ren Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

58

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Ch'ang-ch'un, China
        • Not yet recruiting
        • Jilin University China Japan Union Hospital
        • Contact:
          • Yuansong Bai
      • Changzhou, China
        • Not yet recruiting
        • Changzhou Municipal No.1 People's Hospital
        • Contact:
          • weiying gu
      • Chengdu, China
        • Not yet recruiting
        • Sichuan Provincial People's Hospital
        • Contact:
          • Hui Li
      • Ha'erbin, China
        • Not yet recruiting
        • Harbin Institute of Hematology and Oncology
        • Contact:
          • Hong Liang
      • Hefei, China
        • Not yet recruiting
        • Anhui Provincial Hospital
        • Contact:
          • xiaoyu zhu
      • Jiaxing, China
        • Not yet recruiting
        • The First Hospital of Jiaxing Affiliated Hospital of Jiaxing University
        • Contact:
          • hui Zeng
      • Lanzhou, China
        • Not yet recruiting
        • Gansu Provincial People's Hospital
        • Contact:
          • Qike Zhang
      • Lanzhou, China
        • Not yet recruiting
        • Lanzhou University No.2 Hospital
        • Contact:
          • pengyun zeng
      • Ningbo, China
        • Not yet recruiting
        • Ningbo Medical Center Lihuili Huspital
        • Contact:
          • jing le
      • Shanghai, China
      • Shanghai, China
        • Not yet recruiting
        • Shanghai Ruijin Hospital
        • Contact:
          • Junmin Li
      • Shenyang, China
        • Not yet recruiting
        • The First Hospital of China Medical University
        • Contact:
          • xiaojing Yan
      • Shijia Zhuang, China
        • Not yet recruiting
        • The First Hospital of Hebei Medical University
        • Contact:
          • qingchi liu
      • Shijia Zhuang, China
        • Not yet recruiting
        • The Second Hospital of Hebei Medical University
      • Wuhu, China
        • Not yet recruiting
        • The Second Affiliated Hospital of Wannan Medical College
        • Contact:
          • dongping huang
      • Xi'an, China
        • Not yet recruiting
        • Xi'an International Medical Center
        • Contact:
          • Yingmin Liang
      • Yangzhou, China
        • Not yet recruiting
        • Northern Jiangsu People's Hospital
        • Contact:
          • mei su
      • Yixing, China
        • Not yet recruiting
        • Yixing People's Hospital
        • Contact:
          • Wenzhong Wu
      • Ürümqi, China
        • Not yet recruiting
        • First Affiliated Hospital of Xinjiang Medical University
        • Contact:
          • Ming Jiang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SAV arm
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.
Drug: Selinexor
Selinexor 60mg, PO d3,10,17
Other Names:
  • xpo1 inhibitor
Drug: Azacitidine
Azacitidine 75mg/m2, IV d1-3, 8-9, 15-16
Drug: Venetoclax
Venetoclax 100mg PO on day 1 and 200mg on day 2, 400mg on day 3-14
Other Names:
  • ABT199

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Composite Complete Remission
Time Frame: From the study start up to death (up to approximately 2 years; )
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 Outcome Measures

Outcome Measure
Time Frame
overall survival (OS)
Time Frame: From the study start up to death (up to approximately 4 years; )
From the study start up to death (up to approximately 4 years; )
Overall response rate(ORR)
Time Frame: From the study start up to death (up to approximately 4 years; )
From the study start up to death (up to approximately 4 years; )
percentage of patients who achieved MRD negativity
Time Frame: From the study start up to death (up to approximately 4 years; )
From the study start up to death (up to approximately 4 years; )
Recurrence Free Survival(RFS)
Time Frame: From the study start up to death (up to approximately 4 years; )
From the study start up to death (up to approximately 4 years; )

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Tong Ren Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2023

Primary Completion (Anticipated)

March 30, 2025

Study Completion (Anticipated)

April 30, 2027

Study Registration Dates

First Submitted

February 12, 2023

First Submitted That Met QC Criteria

February 12, 2023

First Posted (Actual)

February 21, 2023

Study Record Updates

Last Update Posted (Actual)

March 15, 2023

Last Update Submitted That Met QC Criteria

March 13, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on AML, Adult

Clinical Trials on Selinexor

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Venezuela

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe