Spots Global Cancer Trial Database for An Efficacy and Safety Study of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine in Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML) and Low-Blast Acute Myelogenous Leukemia (AML)
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Trial Identification
Brief Title: An Efficacy and Safety Study of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine in Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML) and Low-Blast Acute Myelogenous Leukemia (AML)
Official Title: A Phase 2, Randomized, Controlled, Open-Label, Clinical Study of the Efficacy and Safety of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine in Patients With Higher-Risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia and Low-Blast Acute Myelogenous Leukemia
Study ID: NCT02610777
Study Description
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of pevonedistat plus azacitidine versus single-agent azacitidine in participants with HR-MDS or CMML, or low-blast AML.
Detailed Description: The drug being tested in this study is called pevonedistat. Pevonedistat is being tested to treat people with MDS or CMML, or low-blast AML as a combination treatment with azacitidine. This study will look at the overall survival, event free survival and response to treatment in people who take pevonedistat and azacitidine when compared to people who take single-agent azacitidine. The study will enroll 120 participants. Once enrolled, participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups in 28-day treatment cycles: * Pevonedistat 20 mg/m\^2 and azacitidine 75 mg/m\^2 combination * Single-agent azacitidine 75 mg/m\^2 All participants will receive azacitidine via intravenous or subcutaneous route. Participants randomized to the combination arm will also receive pevonedistat intravenous infusion. This multi-center trial will be conducted worldwide. The overall time to participate in this study is approximately 44 months. 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. Participants will enter event-free survival follow-up or response follow-up (study visits every 3 months) if their disease has not transformed to AML (for participants with HR MDS or CMML) or progressed (for participants with low-blast AML), and they have not started subsequent therapy. Participants will also enter overall survival follow-up (contacted every 3 months to document subsequent therapies and survival status).
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama, Birmingham, Alabama, United States
Greenville Health System, Little Rock, Arkansas, United States
UC San Diego Moores Cancer Center, La Jolla, California, United States
Compassionate Cancer Care Medical Group Incorporated, Riverside, California, United States
Rocky Mountain Cancer Centers, Aurora, Colorado, United States
Smilow Cancer Center at Yale New Haven Hospital, New Haven, Connecticut, United States
University of Miami Miller School of Medicine, Miami, Florida, United States
H Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
University of Chicago Medical Center, Chicago, Illinois, United States
Johns Hopkins University, Baltimore, Maryland, United States
San Juan Oncology Associates, Farmington, New Mexico, United States
Monter Cancer Center, Lake Success, New York, United States
Weill Cornell Medical College, New York, New York, United States
Columbia University Medical Center, New York, New York, United States
University of Rochester Medical Center, Rochester, New York, United States
University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
Cleveland Clinic, Cleveland, Ohio, United States
Cancer Care Center of South Texas, New Braunfels, Texas, United States
Nebraska Cancer Specialists, The Woodlands, Texas, United States
Texas Oncology - Waco, TX, Tyler, Texas, United States
University of Virginia, Charlottesville, Virginia, United States
Medical Oncology Associates, Spokane, Washington, United States
Yakima Valley Memorial Hospital, Yakima, Washington, United States
AZ Sint-Jan AV, Brugge, West-Vlaanderen, Belgium
Grand Hopital de Charleroi asbl, Charleroi, , Belgium
Cliniques Universitaires UCL de Mont-Godinne, Yvoir, , Belgium
University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD, Sofia, , Bulgaria
Specialized Hospital for Active Treatment of Haematological Diseases - Sofia, Sofia, , Bulgaria
University Multi-Profile Hospital for Active Treatment Dr Georgi Stranski, Sofia, , Bulgaria
Sunnybrook Health Science Centre, Toronto, Ontario, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
Fakultni Nemocnice Brno, Brno, , Czechia
Fakultni Nemocnice Kralovske Vinohrady, Praha 10, , Czechia
CHU de GRENOBLE, Grenoble, , France
CHRU Lille, Lille, , France
Hopital Saint Louis, Paris, , France
Marien Hospital Akademisches Lehrkrankenhaus, Dusseldorf, , Germany
Universitatsklinikum Ulm, Ulm, , Germany
Tallaght Hospital, Dublin, , Ireland
University Hospital Galway, Galway, , Ireland
Shaare Zedek Medical Center, Jerusalem, , Israel
ZIV Medical Center, Safed, , Israel
Tel Aviv Sourasky Medical Center, Tel Aviv, , Israel
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi, Bologna, , Italy
Azienda Ospedaliera Universitaria Careggi, Firenze, , Italy
Azienda Ospedaliera Bianchi Melacrino Morelli, Reggio Calabria, , Italy
Azienda Ospedaliero Universitaria San Giovanni Battista Di Torino, Torino, , Italy
Zuyderland Medisch Centrum, Sittard, , Netherlands
Hospital Universitario Son Espases, Palma de Mallorca, Baleares, Spain
Hospital Universitario Quironsalud Madrid, Pozuelo De Alarcon, Madrid, Spain
Hospital Universitario Germans Trias i Pujol, Badalona, , Spain
ICO I'Hospitalet Hospital Duran i Reynals Instituto Catalan de Oncologia de Hospitalet (ICO), Barcelona, , Spain
Hospital Clinic de Barcelona, Barcelona, , Spain
Hospital General Universitario Gregorio Maranon, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital Regional Universitario de Malaga - Hospital Universitario Virgen de la Victoria, Malaga, , Spain
Hospital Universitario de Salamanca, Salamanca, , Spain
Hospital Clinico Universitario de Valencia, Valencia, , Spain
Hospital Universitari i Politecnic La Fe de Valencia, Valencia, , Spain
Contact Details
Name: Medical Director
Affiliation: Millennium Pharmaceuticals, Inc.
Role: STUDY_DIRECTOR
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