The purpose of this study is to assess how bleximenib and Venetoclax (VEN)+ Azacitidine (AZA) works as compared to placebo and VEN+AZA alone for the treatment of participants with newly diagnosed Acute Myeloid Leukemia (AML) with a mutation in the NPM1 or KMT2A gene.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
600
Bleximenib will be administered orally.
VEN will be administered orally.
AZA will be administered intravenously or subcutaneously.
Percentage of Participants who Achieve Complete Remission (CR)
CR is defined as Bone marrow blasts less than (\<) 5 percent (%); Absence of circulating blasts; Absence of extramedullary disease; Absolute neutrophil count (ANC) greater than or equal to (\>=) 1.0 \* 10\^9/Liter (1,000/microliter \[mcL\]); Platelet count \>= 100 \* 10\^9/L (100,000/mcL).
Time frame: Up to 4 years and 1 month
Overall Survival (OS)
Overall survival time is defined as the time duration from the date of randomization to death due to any cause.
Time frame: Up to 4 years and 1 month
Event-free survival (EFS)
EFS is defined as the time from randomization to treatment failure, relapse, or death due to any cause, whichever occurs first.
Time frame: Up to 4 years and 1 month
Duration of CR
Duration of CR will be estimated among responders from the date of initial documentation of CR, to the date of first documented evidence of relapse, or death due to any cause, whichever occurs first, respectively.
Time frame: Up to 4 years and 1 month
Time to CR
Time to CR is defined as time from randomization to first documented response.
Time frame: Up to 4 years and 1 month
Rate of CR Without Measurable Residual Disease (MRD-)
Rate of CR MRD- is defined as percentage of participants who have achieved CR without MRD.
Time frame: Up to 4 years and 1 month
Percentage of Participants who Achieved Transfusion Independence
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Placebo will be administered orally.
Cancer Treatment Center of America Phoenix
Goodyear, Arizona, United States
RECRUITINGUniversity of Arkansas at Little Rock
Little Rock, Arkansas, United States
RECRUITINGCity of Hope
Duarte, California, United States
RECRUITINGOrlando Health Cancer Institute
Orlando, Florida, United States
RECRUITINGMoffit Cancer center
Tampa, Florida, United States
RECRUITINGCleveland Clinic Florida
Weston, Florida, United States
RECRUITINGUniversity of Chicago Medicine
Chicago, Illinois, United States
RECRUITINGUniversity of Kentucky Markey Cancer Center
Lexington, Kentucky, United States
RECRUITINGUofL Health Brown Cancer Center
Louisville, Kentucky, United States
RECRUITINGNorton Cancer Institute
Louisville, Kentucky, United States
RECRUITING...and 217 more locations
Transfusion independence is defined as lack of requirement for red blood cell (RBC) and platelet transfusions during any 56-day period.
Time frame: Up to 4 years and 1 month
Percentage of Participants with Allogeneic Hematopoietic Stem Cell Transplant (Allo-HSCT)
Allo-HSCT rate is defined as the percentage of participants who have undergone allo-HSCT after randomization.
Time frame: Up to 4 years and 1 month
Number of Participants with Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
Time frame: Up to 4 years and 1 month
Number of Participants with Abnormalities in Clinical Laboratory Parameters
Participants with abnormalities in clinical laboratory parameters will be reported.
Time frame: Up to 4 years and 1 month
Serum Concentration of Bleximenib
Serum samples will be analyzed to determine concentrations of bleximenib.
Time frame: Up to 4 years and 1 month