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Brief Title: KRT-232 and TKI Study in Chronic Myeloid Leukemia
Official Title: An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 Combined With a Tyrosine Kinase Inhibitor (TKI) in Patients With Relapsed or Refractory Ph+ Chronic Myeloid Leukemia (CML)
Study ID: NCT04835584
Brief Summary: This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with Ph+ Chronic Myeloid Leukemia (CML) who have relapsed or are refractory or intolerant to a Tyrosine Kinase Inhibitor (TKI). This study is a global, open label Phase 1b/2 to determine the efficacy and safety of KRT-232 in patients with chronic phase CML (CML-CP) and accelerated phase (CML-AP) who have failed TKI treatments.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Alabama Birmingham, Birmingham, Alabama, United States
Georgia Cancer Center at Augusta University, Augusta, Georgia, United States
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
Texas Oncology- Sammons CC at Baylor, Dallas, Texas, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Princess Margaret Cancer Center, Toronto, Ontario, Canada
Centre Leon Berard, Lyon, , France
APHM Hopital de la Timone, Marseille, , France
Institut Paoli-Calmettes, Marseille, , France
Centre Hospitalier Lyon Sud, Saint-Genis-Laval, , France
Policlinico di Milano Ospedale Maggiore | Fondazione IRCCS Ca' Granda, Milano, MI, Italy
Azienda Ospedaliero - Universitaria Mater Domini, Catanzaro, , Italy
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori, Meldola FC, , Italy
Fondazione IRCCS Policlinico San Matteo, Pavia, , Italy
Kyungpook National University Hospital, Daegu, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Seoul, , Korea, Republic of
Pratia Onkologia Katowice, Katowice, , Poland
National Medical Research Center of Hematology, Moscow, , Russian Federation
Almazov National Medical Research Center, Saint Petersburg, , Russian Federation
Samara State Medical University, Samara, , Russian Federation
Clínica Universidad de Navarra, Madrid, Navarra, Spain
Clinica Universidad de Navarra, Pamplona, Navarra, Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital Universitario La Paz, Madrid, , Spain