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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05736978
Other study ID # AVS
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date March 31, 2023
Est. completion date March 15, 2027

Study information

Verified date March 2023
Source Shanghai Tong Ren Hospital
Contact Ligen Liu, MD
Phone 18017337037
Email liuligen@shsmu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 58
Est. completion date March 15, 2027
Est. primary completion date March 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Azacitidine
75mg/m2 d1-7
Venetoclax
d1 100mg, d2 200mg, d3-28 400mg
Selinexor
if MRD positive in C1D14, selinexor 60mg D15, D22

Locations

Country Name City State
China Beizhan Hospital Shanghai
China Pla Navy Feature Medical Center Shanghai
China Shanghai Ruijin Hospital Shanghai
China Shanghai Tong Ren hospital Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Tong Ren Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Composite Complete Remission From the study start up to death (up to approximately 2 years; )
Secondary overall survival (OS) From the study start up to death (up to approximately 4 years; )
Secondary Overall response rate(ORR) From the study start up to death (up to approximately 4 years; )
Secondary percentage of patients who achieved MRD negativity From the study start up to death (up to approximately 4 years; )
Secondary Recurrence Free Survival(RFS) From the study start up to death (up to approximately 4 years; )
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