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Brief Title: TL-895 and KRT-232 Study in Acute Myeloid Leukemia
Official Title: An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of TL-895 Combined With KRT-232 in Patients With Relapsed/Refractory (R/R) FLT3+ Acute Myeloid Leukemia (AML)
Study ID: NCT04669067
Brief Summary: This study evaluates TL-895, a potent, orally available and highly selective irreversible tyrosine kinase inhibitor combined with navtemadlin (KRT-232), a novel oral small molecule inhibitor of MDM2 for the treatment of adults with FLT3 mutated Acute Myeloid Leukemia. Participants must be relapsed/refractory (e.g., having failed prior therapy) to be eligible for this study.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Keck School of Medicine, Los Angeles, California, United States
University of California, Irvine Medical Center, Orange, California, United States
Georgia Cancer Center, Augusta, Georgia, United States
Northwestern Memorial Hospital, Chicago, Illinois, United States
Rush University Medical Center, Division of Hematology Oncology and Cell Therapy, Chicago, Illinois, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Weill Cornell Medical College, New York, New York, United States
University of Cincinnati, Cincinnati, Ohio, United States
Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Research Organization, Philadelphia, Pennsylvania, United States
UT Southwestern Medical Center, Harold C. Simmons Cancer Center, Dallas, Texas, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
University of Sunshine Coast-Sippy Downs, Sippy Downs, , Australia
Westmead Hospital, Sydney, , Australia
Ordensklinikum Linz GmbH Elisabethinen, Linz, , Austria
Medical University Vienna, Department of Internal Medicine I, Clinical Department of Hematology and Hemostaseology, Vienna, , Austria
Claude Huriez Hospital, Lille, , France
South Lyon Hospital Center, Lyon, , France
Paoli-Calmettes Institute, Marseille, , France
University Hospital of Nantes, Nantes, , France
Hospital Center Universitaire De Nice, Nice, , France
Saint-Louis Hospital, Paris, , France
University Hospital Halle (Saale), Department of Internal Medicine IV - Hematology and Oncology, Halle, Sachsen-Anhalt, Germany
University Duisburg-Essen, University Hospital Essen, Department of Internal Medicine, Essen, , Germany
University Hospital Hamburg-Eppendorf, Department of Internal Medicine II, Hamburg, , Germany
Hannover Medical School, Center for Internal Medicine, Clinic of Hematology, Hemostaseology, Oncology and Stem Cell Transplantation, Hannover, , Germany
University Hospital Jena, Clinic of Internal Medicine II, Department of Hematology and Medical Oncology, Jena, , Germany
University Hospital - Ospedali Riuniti Umberto I - GM Lancisi - G Salesi of Ancona, Haematology Clinic, Ancona, , Italy
Polyclinic S. Orsola-Malpighi, Operative Unit of Hematology, Bologna, , Italy
Romagnolo Scientific Institute of Meldola (IRST) S.r.l., Department of Oncology and Clinical and Experimental Haematology, Meldola, , Italy
Gachon University Gil Medical Center, Incheon, , Korea, Republic of
Seoul National University Hospital, Department of Hemato-Oncology, Seoul, , Korea, Republic of
University Hospital Germans Trias i Pujol, Department of Clinical Hematology, Badalona, , Spain
University Hospital Vall d'Hebron, Barcelona, , Spain
University Clinical Hospital of Valencia, Department of Hematology and Medical Oncology, Valencia, , Spain
Hospital Universitario y Politécnico de La Fe, València, , Spain