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Adaptive Treatment for Acute Myeloid Leukemia Based on D14 MRD Results (AVS)

Primary Purpose

AML, MRD

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Azacitidine
Venetoclax
Selinexor
Sponsored by
Shanghai Tong Ren Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for AML focused on measuring untreated AML, MRD results, selinexor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 . 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

  • Beizhan Hospital
  • Pla Navy Feature Medical Center
  • Shanghai Ruijin Hospital
  • Shanghai Tong Ren hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment regimen based on C1D14 MRD

Arm Description

Untreated acute myeloid leukemia who are ineligible for intensive chemotherapy will be given azacitidine 75mg/m2, d1-7 and venetoclax 100mg on day 1 and 200mg on day 2, 400mg on day 3-28. Based on MRD results on C1D14, MRD negative patients will go on azacitidine and venetoclax regimen and for patients with MRD positive, selinexor 60mg on D15 and D22 will be added. 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.

Outcomes

Primary Outcome Measures

Percentage of Participants With Composite Complete Remission

Secondary Outcome Measures

overall survival (OS)
Overall response rate(ORR)
percentage of patients who achieved MRD negativity
Recurrence Free Survival(RFS)

Full Information

First Posted
February 12, 2023
Last Updated
March 13, 2023
Sponsor
Shanghai Tong Ren Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05736978
Brief Title
Adaptive Treatment for Acute Myeloid Leukemia Based on D14 MRD Results
Acronym
AVS
Official Title
Clinical Efficacy and Safety of Adaptive Treatment of Acute Myeloid Leukemia (AML) Based on D14 MRD results-a Multicenter, Single-arm, Prospective Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 31, 2023 (Anticipated)
Primary Completion Date
March 1, 2025 (Anticipated)
Study Completion Date
March 15, 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 based on MRD results on day 14 of the first cycle.
Detailed Description
Azacitidine and Venetoclax will be given at the approved dose regimen for 75mg/m2, d1-7(azacitidine) and 100mg on day 1 and 200mg on day 2, 400mg on day 3-28 (venetoclax), 28 days per cycle. Based on MRD results on C1D14, MRD negative patients will go on azacitidine and venetoclax regimen and for patients with MRD positive, selinexor 60mg on D15 and D22 will be added. 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, MRD
Keywords
untreated AML, MRD results, selinexor

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
Treatment regimen based on C1D14 MRD
Arm Type
Experimental
Arm Description
Untreated acute myeloid leukemia who are ineligible for intensive chemotherapy will be given azacitidine 75mg/m2, d1-7 and venetoclax 100mg on day 1 and 200mg on day 2, 400mg on day 3-28. Based on MRD results on C1D14, MRD negative patients will go on azacitidine and venetoclax regimen and for patients with MRD positive, selinexor 60mg on D15 and D22 will be added. 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.
Intervention Type
Drug
Intervention Name(s)
Azacitidine
Intervention Description
75mg/m2 d1-7
Intervention Type
Drug
Intervention Name(s)
Venetoclax
Other Intervention Name(s)
ABT-199
Intervention Description
d1 100mg, d2 200mg, d3-28 400mg
Intervention Type
Drug
Intervention Name(s)
Selinexor
Other Intervention Name(s)
XPO1 inhibitor
Intervention Description
if MRD positive in C1D14, selinexor 60mg D15, D22
Primary Outcome Measure Information:
Title
Percentage of Participants With Composite Complete Remission
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 . 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
liuligen@shsmu.edu.cn
Facility Information:
Facility Name
Beizhan Hospital
City
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Hao
Facility Name
Pla Navy Feature Medical Center
City
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rong Li
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

12. IPD Sharing Statement

Plan to Share IPD
No

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Adaptive Treatment for Acute Myeloid Leukemia Based on D14 MRD Results

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