Acute Myeloid Leukemia Clinical Trial
A Study to Evaluate Lanraplenib (LANRA) in Combination With Gilteritinib in Participants With FLT3-mutated Relapsed or Refractory Acute Myeloid Leukemia (AML)
The primary objective of this study is to evaluate the safety of lanraplenib (LANRA) in combination with the FMS-like tyrosine kinase 3 (FLT3) inhibitor gilteritinib, in participants with relapsed or refractory (R/R) FLT3-mutated acute myeloid leukemia (AML).
Adults ≥18 years of age with acute myeloid leukemia (AML) and at least 1 prior line of therapy
FMS-like tyrosine kinase 3 (FLT3)-mutated disease documented in a local reference laboratory
Have the ability to understand the requirements and procedures of the study and sign a written informed consent form
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2
Adequate hepatic and renal function
Prothrombin time (PT), activated partial thromboplastin time (aPTT) and international normalized ratio (INR) ≤1.5x upper limit of normal (ULN) unless receiving therapeutic anticoagulation
Negative serum ß-human chorionic gonadotropin (HCG) test in women of child-bearing potential (WOCBP)
Left ventricular ejection fraction ≥50% confirmed by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan
Known central nervous system (CNS) involvement with leukemia
Clinical signs/symptoms of leukostasis that have failed therapy including hydroxyurea and/or leukapheresis of at least 3 days duration
Pregnant or breastfeeding women
Active infection with hepatitis B, C or human immunodeficiency virus (HIV) infection
Disseminated intravascular coagulation with active bleeding or signs of thrombosis
Known active coronavirus disease 2019 (COVID-19)
Administration of a live attenuated virus vaccine within 35 days before Cycle 1 Day 1 (C1D1)
History of non-myeloid malignancy except for the following: adequately treated localized basal cell or squamous cell carcinoma of the skin; cervical carcinoma in situ; superficial bladder cancer; asymptomatic prostate cancer without known metastatic disease, with no requirement for therapy or requiring only hormonal therapy and with normal prostate specific antigen for > 1 year prior to start of study therapy; or any other cancer that has been in complete remission without treatment for ≥3 years prior to enrollment
Clinically significant heart disease
Prolongation of the congenital long measure between Q wave and T wave in the electrocardiogram (QT) interval at baseline
Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection at the time of study treatment initiation
Current (within 30 days of study enrollment) drug-induced liver injury, chronic active hepatitis, alcoholic liver disease, nonalcoholic steatohepatitis, primary biliary cholangitis with inadequate response to ursodeoxycholic acid or other health authority approved therapy, extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, orportal hypertension
Ongoing (within 6 weeks of study enrollment) hepatic encephalopathy
Ongoing immunosuppressive therapy, including systemic chemotherapy for treatment of leukemia
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