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Trial Title:
Adaptive Treatment for Acute Myeloid Leukemia Based on D14 MRD Results
NCT ID:
NCT05736978
Condition:
AML
MRD
Conditions: Official terms:
Leukemia, Myeloid, Acute
Azacitidine
Venetoclax
Conditions: Keywords:
untreated AML
MRD results
selinexor
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Azacitidine
Description:
75mg/m2 d1-7
Arm group label:
Treatment regimen based on C1D14 MRD
Intervention type:
Drug
Intervention name:
Venetoclax
Description:
d1 100mg, d2 200mg, d3-28 400mg
Arm group label:
Treatment regimen based on C1D14 MRD
Other name:
ABT-199
Intervention type:
Drug
Intervention name:
Selinexor
Description:
if MRD positive in C1D14, selinexor 60mg D15, D22
Arm group label:
Treatment regimen based on C1D14 MRD
Other name:
XPO1 inhibitor
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Beizhan Hospital
Address:
City:
Shanghai
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jie Hao
Facility:
Name:
Pla Navy Feature Medical Center
Address:
City:
Shanghai
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Rong Li
Facility:
Name:
Shanghai Ruijin Hospital
Address:
City:
Shanghai
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Junmin Li
Facility:
Name:
Shanghai Tong Ren hospital
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Ligen Liu
Start date:
March 31, 2023
Completion date:
March 15, 2027
Lead sponsor:
Agency:
Shanghai Tong Ren Hospital
Agency class:
Other
Source:
Shanghai Tong Ren Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05736978
