A Study to Evaluate Lanraplenib (LANRA) in Combination With Gilteritinib in Participants With FLT3-mutated Relapsed or Refractory Acute Myeloid Leukemia (AML)
- Conditions
- Acute Myeloid LeukemiaMedDRA version: 21.0Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2022-001279-15-ES
- Lead Sponsor
- Kronos Bio, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 55
- Adults =18 years of age with acute myeloid leukemia (AML) and at least 1 prior line of therapy
- 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
- 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 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
- Patients with a corrected QT interval (using the Fridericia formula, QTcF) >480 msec or Long QT Syndrome
- 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, or portal hypertension
- Ongoing (within 6 weeks of study enrollment) hepatic encephalopathy
- Ongoing immunosuppressive therapy, including systemic chemotherapy for treatment of leukemia
- Subject requiring chronic treatment with strong cytochrome P450 (CYP) 3A4 inhibitors or inducers beginning 7 days prior to initiating study treatment until study treatment completion
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method