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Brief Title: Alvocidib Biomarker-driven Phase 2 AML Study
Official Title: Phase 2, Randomized, Biomarker-driven Clinical Study in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With MCL-1 Dependence ≥30%
Study ID: NCT02520011
Brief Summary: The purpose of this two-stage Phase 2 study is to assess the clinical response (Complete Remission) of ACM (Alvocidib/Cytarabine/Mitoxantrone) compared to CM (Cytarabine/Mitoxantrone) treatment in refractory or relapsed AML patients with demonstrated MCL-1 dependence of ≥ 30% by mitochondrial profiling in bone marrow.
Detailed Description: In Stage 1 of the study, all eligible AML patients with demonstrated MCL-1 dependence of ≥ 30% by mitochondrial profiling in bone marrow will receive treatment with ACM. In Stage 2, all eligible AML patients with demonstrated MCL-1 dependence of ≥ 30% by mitochondrial profiling in bone marrow will be randomized 1:1 to receive either treatment with ACM or CM.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Honor Health Research Institute, Scottsdale, Arizona, United States
University of California Los Angeles (UCLA), Los Angeles, California, United States
University of California San Diego UCSD, San Diego, California, United States
Mayo Clinic Florida, Jacksonville, Florida, United States
Northside Hospital, Atlanta, Georgia, United States
Northwestern Memorial Hospital, Chicago, Illinois, United States
University of Iowa, Iowa City, Iowa, United States
University of Kansas Medical Center, Westwood, Kansas, United States
Ochsner Clinic Foundation, New Orleans, Louisiana, United States
Sidney Kimmel Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
University of Michigan, Ann Arbor, Michigan, United States
Mayo Clinic Rochester, Rochester, Minnesota, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
Morristown Cancer Center, Morristown, New Jersey, United States
Roswell Park Cancer Center Institute, Buffalo, New York, United States
Hudson Valley Cancer Center, Hawthorne, New York, United States
Columbia University Medical Center, New York, New York, United States
University of North Carolina, Chapel Hill, North Carolina, United States
Duke, Durham, North Carolina, United States
East Carolina University, Greenville, North Carolina, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
Ohio State University, Columbus, Ohio, United States
West Penn Allegheny Hospital, Pittsburgh, Pennsylvania, United States
Baylor Sammons Cancer Center, Dallas, Texas, United States
MD Anderson Cancer Center, Houston, Texas, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Princess Margaret Cancer Center, Toronto, Ontario, Canada
Hospital Regional Universitario de Malaga, Málaga, Malaga, Spain
Complejo Hospitalario Universitario de Albacete, Albacete, , Spain
Institut Catala d'Oncologia, Badalona, , Spain
Hospital Clinic de Barcelona, Barcelona, , Spain
Hospital San Pedro de Alcantara, Cáceres, , Spain
Hospital Universitario Central de Asturias - HUCA, Oviedo, , Spain
Hospital Clinico Universitario de Salamanca, Salamanca, , Spain
Hospital Universitari i Politècnic La Fe, Valencia, , Spain
University Hospitals of Wales, Cardiff, Wales, United Kingdom
Univ Hospital of Bristol, Bristol, , United Kingdom
Guys Hospital St. Thomas, London, , United Kingdom
Name: Stephen Anthony, DO
Affiliation: Sumitomo Pharma America, Inc.
Role: STUDY_DIRECTOR