Spots Global Cancer Trial Database for A Study of Pevonedistat and Venetoclax Combined With Azacitidine to Treat Acute Myeloid Leukemia (AML) in Adults Unable to Receive Intensive Chemotherapy
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Trial Identification
Brief Title: A Study of Pevonedistat and Venetoclax Combined With Azacitidine to Treat Acute Myeloid Leukemia (AML) in Adults Unable to Receive Intensive Chemotherapy
Official Title: A Randomized, Open-label, Controlled, Phase 2 Study of Pevonedistat, Venetoclax, and Azacitidine Versus Venetoclax Plus Azacitidine in Adults With Newly Diagnosed Acute Myeloid Leukemia Who Are Unfit for Intensive Chemotherapy
Study ID: NCT04266795
Conditions
Study Description
Brief Summary: The main aim is to see how the combination of pevonedistat + venetoclax + azacitidine compares to venetoclax + azacitidine in adults recently diagnosed with AML who are unable to be treated with intensive chemotherapy. Participants will receive either pevonedistat + venetoclax + azacitidine or venetoclax + azacitidine in 28-day treatment cycles. Bone marrow samples (biopsy) will be collected throughout the study. Pevonedistat will be given as an intravenous (IV) infusion and Azacitidine will be given through IV or subcutaneous (under the skin). Study treatments may continue as long as the participant is receiving benefit from it. Participants may choose to stop treatment at any time.
Detailed Description: The drug being tested in this study is called Pevonedistat. Pevonedistat is being tested to treat people who have AML. This study will compare the improvement in EFS in Arm A: Pevonedistat + Venetoclax + Azacitidine combination arm group when compared with Arm B: Venetoclax + Azacitidine. The study will enroll approximately 164 patients. Participants will be randomly assigned in 1:1 ratio to one of the two treatment groups in 28-day treatment cycles and which will remain disclosed to the patient and study doctor during the study: * Pevonedistat 20 mg/m\^2 + Venetoclax 400 mg (ramp-up dose, Cycle 1 only: 100-400mg) + Azacitidine 75 mg/m\^2 * Venetoclax 400 mg (ramp-up dose, Cycle 1 only: 100-400 mg) + Azacitidine 75 mg/m\^2 This multi-center trial will be conducted worldwide. The overall time to participate in this study is approximately 3 years. Participants will attend the end-of-treatment visit 30 days after the last dose of study drug or before the start of subsequent anti-neoplastic therapy if that occurs sooner.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
UC San Diego Moores Cancer Center, La Jolla, California, United States
UC Irvine Medical Center, Orange, California, United States
University of Miami Miller School of Medicine, Miami, Florida, United States
AdventHealth (Florida Hospital) - Transplant Institute, Orlando, Florida, United States
Norton Cancer Institute - Suburban, Louisville, Kentucky, United States
Tulane Medical Center, New Orleans, Louisiana, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
HCA Midwest Health - SCRI - PPDS, Kansas City, Missouri, United States
Northwell Health Cancer Institute, Lake Success, New York, United States
Icahn School of Medicine at Mount Sinai, New York, New York, United States
Stony Brook Medicine, Stony Brook, New York, United States
University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
The University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Rhode Island Hospital, Providence, Rhode Island, United States
Avera Cancer Institute, Sioux Falls, South Dakota, United States
Houston Methodist Cancer Center, Houston, Texas, United States
Joe Arrington Cancer Research and Treatment Center, Lubbock, Texas, United States
Intermountain LDS Hospital, Salt Lake City, Utah, United States
University of Virginia Health System, Charlottesville, Virginia, United States
West Virginia University Hospital, Morgantown, West Virginia, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
University of Alberta, Edmonton, Alberta, Canada
Tom Baker Cancer Centre, Tom Baker Cancer Centre, Alberta, Canada
London Health Sciences Centre, London, Ontario, Canada
Ottawa Hospital, Ottawa, Ontario, Canada
Hopital de L'enfant Jesus, Quebec City, Quebec, Canada
Centre Hospitalier Le Mans, Le Mans, Sarthe, France
Hopital Avicenne, Bobigny, , France
Institut dHematologie de Basse Normandie, Caen, , France
CHU de Grenoble, Grenoble, , France
CHRU Lille, Lille, , France
CHRU Nantes, Nantes, , France
CHU de Nice, Nice, , France
Hopital Saint Antoine, Paris, , France
Hopital Saint Louis, Paris, , France
Centre Hospitalier Lyon Sud, Pierre Benite, , France
CHRU de Poitiers La Miletrie, Poitiers, , France
EDOG - Institut Claudius Regaud - PPDS, Toulouse, , France
Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli, Reggio Calabria, Calabria, Italy
ASST di Monza - Azienda Ospedaliera San Gerardo, Monza, Lombardia, Italy
Istituto Clinico Humanitas, Rozzano, Milano, Italy
Azienda Sanitaria Ospedaliera S Luigi Gonzaga, Orbassano, Piemonte, Italy
Azienda Ospedaliera Citta della Salute e della Scienza di Torino, Torino, Piemonte, Italy
Ospedale Santa Maria Della Misericordia Di Perugia, Perugia, Umbria, Italy
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi, Bologna, , Italy
Azienda Ospedaliera Universitaria Careggi, Firenze, , Italy
Fondazione IRCCS Policlinico San Matteo di Pavia, Pavia, , Italy
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi, Lodz, Lodzkie, Poland
Szpital Uniwersytecki w Krakowie, Krakow, Malopolskie, Poland
MTZ Clinical Research Sp z o o, Warszawa, Mazowieckie, Poland
Instytut Hematologii i Transfuzjologii, Warszawa, Mazowieckie, Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku, Bialystok, Podlaskie, Poland
Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy, Bydgoszcz, , Poland
Uniwersyteckie Centrum Kliniczne, Gdansk, , Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie, Lublin, , Poland
Contact Details
Name: Study Director
Affiliation: Takeda
Role: STUDY_DIRECTOR
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