Correlated Drug Terms (3)

Correlated MeSH Terms (3)

Correlated HPO Terms (3)

Primary Outcomes

Description: A DLT is defined as any of the events meeting the DLT criteria that occur during the observation period and that is considered to be possibly or probably related to gilteritinib. Nonhematologic Dose-limiting Toxicity will be defined as grade 3 or 4 nonhematologic toxicity attributable to gilteritinib that persists for > 48 hours without resolution to grade ≤ 2, will have gilteritinib dosing interrupted. Exceptions include the toxicities commonly seen with intensive AML reinduction regimens. Hematologic Dose-limiting Toxicity will be defined as failure to recover a peripheral absolute neutrophil count (ANC) > 500/μL and non-transfusion dependent platelet count > 20000/μL due to documented bone marrow aplasia/hypoplasia for greater than or equal to 50 days from the start of cycle 1 day 1. Failure to recover peripheral counts due to disease involvement of the bone marrow will not be considered dose-limiting toxicity.

Description: CR rate is defined as the number of participants who achieve the best response of CR divided by the number of participants in the analysis population. Complete remission is defined as having bone marrow regenerating normal hematopoietic cells and achieving a morphologic leukemia-free state and must have an absolute neutrophil count (ANC) ≥ 1 x 10^9/L and platelet count ≥ 100 x 10^9/L and normal marrow differential with < 5% blasts, and they will be red blood cell (RBC) and platelet transfusion independent (defined as 1 week without RBC transfusion and 1 week without platelet transfusion). There should be no evidence of extramedullary leukemia.

Description: CRc rate is defined as the number of participants who achieve the best response of CRc (CR, CRp,or CRi) divided by the number of participants in the analysis population. Complete remission with incomplete platelet recovery (CRp) is defined as achieving CR except for incomplete platelet recovery (< 100 x 10^9/L) at a post baseline visit. Complete remission with incomplete hematologic recovery (CRi) is defined as achieving CR except for incomplete hematological recovery with residual neutropenia < 1 x 10^9/L with or without complete platelet recovery at a post baseline visit. Red blood cell (RBC) and platelet transfusion independence is not required.

Secondary Outcomes

Description: An AE is any untoward medical occurrence in a participant administered a study drug, and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.

Description: Number of participants with potentially clinically significant vital sign values.

Description: Number of participants with potentially clinically significant laboratory values.

Description: Number of participants with potentially clinically significant ECG values.

Description: Inhibition of FLT3 phosphorylation after drug treatment will be determined relative to pre-treatment phosphorylated FLT3 levels in participants to assess the relationship with gilteritinib dose. Phosphorylated FLT3 will be measured by plasma inhibitory activity (PIA) assay.

Description: CL/F will be reported from the PK plasma samples collected.

Description: Vd/F will be reported from the PK plasma samples collected.

Description: Cmax will be reported from the PK plasma samples collected.

Description: tmax will be reported from the PK plasma samples collected.

Description: AUC will be reported from the PK plasma samples collected.

Description: EFS is defined as the time from the date of enrollment until the date of documented relapse (excluding relapse after PR), treatment failure or death, whichever occurs first. If a participant experiences relapse or death, the participant is defined as having EFS event related to either "relapse" or "death", and the event date is the date of relapse or death. If a participant fails to achieve any of the response of CR, CRp, CRi or PR during the treatment period, the participant is defined as having EFS event related to treatment failure, and the event date is the enrollment date. For a participant who is not known to have had a relapse or treatment failure or death event, EFS is censored at the date of last relapse-free disease assessment. Participant is not censored at hematopoietic stem cell transplant (HSCT).

Description: OS is defined as the time from the date of enrollment until the date of death from any cause. For a participant who is not known to have died by the end-of-study follow-up, OS is censored at the date of last contact.

Description: MRD negative status will be defined as FLT3-internal tandem duplication (ITD) signal ratio ≤ 10^-4.

Description: MRD negative status will be defined as FLT3-internal tandem duplication (ITD) signal ratio ≤ 10^-4.

Description: MRD negative status will be defined as FLT3-internal tandem duplication (ITD) signal ratio ≤ 10^-4.

Description: MRD negative status will be defined as FLT3-internal tandem duplication (ITD) signal ratio ≤ 10^-4.

Description: The acceptability and palatability of gilteritinib oral formulation as assessed by the participant using a single scale. The 5 point facial hedonic scale has high to low as: Liked it Very Much, Liked it a Little, Not sure, Disliked it a Little, Disliked it Very Much.

HP:0006733: Acute megakaryocytic leukemia

Genes 1

Protein Mutations 0

SNP 0

HP:0004808: Acute myeloid leukemia

Genes 48

Protein Mutations 22

SNP 4

HP:0001909: Leukemia

Genes 190

Protein Mutations 56

SNP 17

HP:0012324: Myeloid leukemia

Genes 20

Protein Mutations 33

SNP 9