FLOTATO TRIAL SKIN

Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection.If a fungal infection is present, the participant must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to registration. If a bacterial or viral infection is present, the participant must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to registration. Participant has an uncontrolled infection. Participants who have had past exposure and have no detectable virus either through spontaneous clearance or treatment are eligible. NAAT must be performed if the participant has positive serology for hepatitis C. Participant has active hepatitis C infection as determined by NAAT.Participants who have acquired immunity from past exposure (HBcAb positive / HBsAb positive / HBsAg negative) are eligible. Participant has active hepatitis B infection as determined by NAAT or surface antigen assay.Participant has a known infection with human immunodeficiency virus (HIV).Participant has long QT Syndrome at screening.

Participant has Karnofsky performance status score 450 msec (average of triplicate determinations) per central read.Participant has had a prior allogeneic transplant.Participant is able to take oral medication.

FLOTATO TRIAL SKIN

(Note that increasing calcineurin inhibitors or sirolimus to achieve therapeutic trough levels is allowed.) Topical skin and topical gastrointestinal steroids are allowed.

No escalation of systemic immunosuppression in terms of increase of corticosteroids or addition of new agent / modality within 2 weeks of randomization.

TBL 0.5 mg/kg of prednisone (or equivalent) daily dose within 1 week of randomization.

Serum AST and/or alanine aminotransferase (ALT) 40 mL/min/1.73m2 as calculated with the Cockcroft-Gault equation with adjustment if total body weight is ≥ 125% of ideal body weight.

Total bilirubin (TBL) ≤ 2.5 mg/dL, except for participants with Gilbert's syndrome.

For the purposes of registration, CR1 will be defined as 40 mL/min/1.73m2 as calculated with the Cockcroft-Gault equation with adjustment if total body weight is ≥ 125% of ideal body weight. Participant has confirmed, morphologically documented AML in CR1.

Participant consents to allow access to diagnostic BM aspirate or PB sample and/or the DNA derived from that sample, if available, that may be used to validate a companion diagnostic that is being developed in parallel with gilteritinib.

Participant is considered a legal adult by local regulation at the time of signing informed consent form (ICF).

Participant is considered a suitable candidate for HCT and has an acceptable source of allogeneic donor stem cells, as defined per institutional practice (allogeneic HCT for any donor source and any graft source, and any conditioning will be permitted).

Why Should I Register and Submit Results?.

Hypersensitivity against 5- Fluorouracil, Leucovorin, Oxaliplatin, Cisplatin.

distant metastases or infiltration of adjacent structures or organs and all primarily not resectable stages.

Ejection fraction > 50% in echocardiography before start of therapy.

Serum creatinin ≤ 1.5x of normal value, or Creatinin-Clearance > 50 ml/min.

Exclusion of peritoneal carcinomatosis (if clinically suspected) via laparoscopy.locally advanced (>T1) and/or nodal positive (N+) histologically proven adenocarcinoma of the esophagogastreal junction (AEG I-III) or the stomach without distant metastases (M0) and without infiltration of adjacent structures and organs.

Flotato trial