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Spots Global Cancer Trial Database for Alvocidib Biomarker-driven Phase 2 AML Study

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Stephen Anthony, DO

Affiliation: Sumitomo Pharma America, Inc.

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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