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)

Summary

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).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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 at the time of consideration for enrollment in the study
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

Exclusion Criteria:

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, or localized melanoma (with TNM stage either Tis [melanoma in-situ] or T1aN0M0) with complete resection; 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

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

24

Study ID:

NCT05028751

Recruitment Status:

Active, not recruiting

Sponsor:

Kronos Bio

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There are 17 Locations for this study

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University of California Los Angeles (UCLA)
Los Angeles California, 99009, United States
The Blood and Marrow Transplant Group of Georgia
Atlanta Georgia, 30342, United States
University of Chicago Medical Center
Chicago Illinois, 60637, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Oregon Health and Science University
Portland Oregon, 97239, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas Texas, 75246, United States
University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
Froedtert Hospital
Milwaukee Wisconsin, 53226, United States
Hospital Universitario 12 de Octubre
Madrid Avenida De Córdoba Sin Número, 28041, Spain
Hospital Germans Trias i Pujol
Barcelona Badalona, 08916, Spain
MD Anderson Cancer Center Madrid
Madrid Calle De Arturo Soria, 270, Spain
Hospital Universitari Vall d'Hebrón
Barcelona , 08035, Spain
Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)
Barcelona , 08908, Spain
Hospital Clínic de Barcelona
Barcelona , 170, Spain
Hospital San Pedro de Alcantara
Cáceres , 10001, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid , 28040, Spain
Hospital Universitari i Politècnic La Fe
Valencia , 46026, Spain

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

24

Study ID:

NCT05028751

Recruitment Status:

Active, not recruiting

Sponsor:


Kronos Bio

How clear is this clinincal trial information?

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