This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, when administered alone and in combination with low-dose cytarabine (LDAC) or Decitabine for the treatment of adults with Acute Myeloid Leukemia (AML) and AML secondary to myeloproliferative neoplasms (MPN). Participants must be relapsed/refractory (having failed prior therapy) and will be assigned to receive monotherapy (KRT-232 alone) or combination therapy (KRT-232 with LDAC or KRT-232 with Decitabine).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
KRT-232 is an experimental MDM2 inhibitor anti-cancer drug taken by mouth.
Cytarabine is an anti-cancer chemotherapy drug taken via injection.
Decitabine is an anti-cancer chemotherapy drug taken via injection.
University of Chicago
Chicago, Illinois, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Mount Sinai
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Weill Cornell
New York, New York, United States
Part A: To determine KRT-232 recommended phase 2 dose (RP2D)
Number of dose-limiting toxicities (DLTs) of KRT-232 in combination with cytarabine or decitabine
Time frame: 28 Days
Part B: To determine the RP2D of KRT-232
The safety review committee (SRC) will determine the RP2D based on safety and tolerability data obtained from each arm
Time frame: 2 years after last patient enrolled
Part A: To determine the rates of complete remission (CR) and complete remission with partial hematological improvement (CRh)
Proportion of patients achieving complete remission (CR) or complete remission with partial hematological improvement (CRh) as determined by Modified 2017 European LeukemiaNet (ELN) response criteria
Time frame: 12 weeks
Part B: To determine the rates of complete remission (CR), CR with partial hematological improvement (CRh) and CR with incomplete hematologic recovery (CRi)
Proportion of patients achieving complete remission (CR), complete remission with partial hematological improvement (CRh), and CR with incomplete hematologic recovery (CRi) as determined by Modified 2017 European LeukemiaNet (ELN) response criteria
Time frame: 12 weeks
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The Ohio State University
Columbus, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
MD Anderson Cancer Center
Houston, Texas, United States
Monash Health
Clayton, Australia
St. George Hospital
Kogarah, Australia
...and 49 more locations