Spots Global Cancer Trial Database for Study of Azacitidine With or Without Birinapant in Subjects With MDS or CMMoL
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Trial Identification
Brief Title: Study of Azacitidine With or Without Birinapant in Subjects With MDS or CMMoL
Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Azacitidine With or Without Birinapant With a Single Arm Open-Label Run-In Phase in Subjects With Higher Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia
Study ID: NCT02147873
Study Description
Brief Summary: This is a randomized double blind placebo controlled study of azacitidine with or without birinapant in subjects with higher risk Myelodysplastic syndrome, secondary MDS or myelomonocytic leukemia (CMMoL) who are naïve, to azacitidine therapy. Pre-clinical and mechanistic studies support that azacitidine may modulate pathways that enable birinapant-mediated anti-tumor activity.
Detailed Description: This is a randomized double blind placebo controlled study of azacitidine with or without birinapant in subjects with higher risk Myelodysplastic syndrome, secondary MDS or myelomonocytic leukemia (CMMoL) The primary purpose of this study is : -To compare the relative effect of azacitidine plus birinapant versus azacitidine plus placebo on response rate in patients with higher-risk MDS, secondary MDS or CMMoL. The secondary purpose of this study is to compare effect of azacitidine plus birinapant relative to azacitidine with placebo on: * Hematologic improvement * Relapse free survival * Time to respond * Change in transfusion requirements * Duration of response * Overall survival * Adverse events The exploratory objective of this study is to assess exploratory translational biomarkers for antitumor effects.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Palo Verde Hematology Oncology, Glendale, Arizona, United States
Arizona Center for Cancer Care, Glendale, Arizona, United States
Mayo Clinic, Scottsdale, Arizona, United States
Arizona Oncology Associates, Tucson, Arizona, United States
Ronald Reagan UCLA Medical Center, Los Angeles, California, United States
North County Oncology, Oceanside, California, United States
Desert Hematology Oncology Medical Group, Rancho Mirage, California, United States
Stanford Hospital and Clinics, Stanford, California, United States
Wellness Oncology & Hematology, West Hills, California, United States
Colorado Blood Cancer Institute, Denver, Colorado, United States
Cancer Specialists of North Florida, Jacksonville, Florida, United States
Mayo Clinic Jacksonville, Jacksonville, Florida, United States
Hematology Oncology Associates of the Treasure Coast, Port St. Lucie, Florida, United States
H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States
Bond Clinic PA, Winter Haven, Florida, United States
Loyola University Medical Center, Maywood, Illinois, United States
Simmons Cancer Institute at Southern Illinois University, Springfield, Illinois, United States
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
University of Louisville Hospital/James Graham Brown Cancer Center, Louisville, Kentucky, United States
Tulane Medical Center, New Orleans, Louisiana, United States
University of Maryland, Greenebaum Cancer Center, Baltimore, Maryland, United States
University of Massachusetts Worcester, Worcester, Massachusetts, United States
St. Joseph Mercy Hospital, Ann Arbor, Michigan, United States
New Jersey Hematology Oncology Associates, Brick, New Jersey, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
University of New Mexico Cancer Center, Albuquerque, New Mexico, United States
Montefiore Medical Center, Bronx, New York, United States
North Shore Hematology Oncology Associates, East Setauket, New York, United States
Monter Cancer Center, Lake Success, New York, United States
Columbia University Medical Center, New York, New York, United States
Weill Cornell Medical College - New York-Presbyterian Hospital, New York, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Gabrail Cancer Center Research, Canton, Ohio, United States
Oncology Hematology Care, Inc., Cincinnati, Ohio, United States
Oregon Health and Sciences University, Portland, Oregon, United States
Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
Medical University of South Carolina, Hollings Cancer Center, Charleston, South Carolina, United States
Carolina Blood and Cancer Care Associates, P.A., Rock Hill, South Carolina, United States
Tennessee Oncology, Chattanooga, Tennessee, United States
Tennessee Oncology, Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Tyler Hematology Oncology PA, Tyler, Texas, United States
Utah Cancer Specialists, Salt Lake City, Utah, United States
University of Utah, Huntsman Cancer Hospital, Salt Lake City, Utah, United States
Virginia Commonwealth University Massey Cancer Center, Richmond, Virginia, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia
Westmead Hospital, Westmead, New South Wales, Australia
Metro South Health, Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Royal Hobart Hospital, Hobart, Tasmania, Australia
Austin Health, Heidelberg, Victoria, Australia
Cabrini Hospital, Malvern, Victoria, Australia
The Alfred, Melbourne, Victoria, Australia
Border Medical Oncology, Wodonga, Victoria, Australia
Perth Blood Institute, Nedlands, Western Australia, Australia
Klinikum Rechts der Isar, Technischen Universitat Munchen, Munchen, Bayern, Germany
Klinikum der Ludwig-Maximilians-Universitat Munchen, Munich, Bayern, Germany
Marien Hospital Dusseldorf, Dusseldorf, Nordrhein-Westfalen, Germany
University Hospital of Cologne, Cologne, North Rhine Westphalia, Germany
University Hospital Halle, Halle (Saale), Saxony-Anhalt, Germany
Universitatsklinikum Essen, Essen, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
Medizinische Universitatsklinik Heidelberg, Heidelberg, , Germany
Universitatsklinikum Wurzburg, Wurzburg, , Germany
Hospital Universitario Severo Ochoa, Leganes, Madrid, Spain
Hospital Clinico Universitario Virgen de la Arrixaca, El Palmar, Murcia, Spain
Clinica Universidad de Navarra, Pamplona, Navarra, Spain
Hospital Universitario de Canarias, La Laguna, S/C Tenerife, Spain
Hospital Germans Trias I Pujol, Badalona, , Spain
Hospital University Reina Sofia, Cordoba, , Spain
Hospital Universitario Gregorio Maranon, Madrid, , Spain
MD Anderson Cancer Center, Madrid, , Spain
Hospital Universitario de Salamanca, Salamanca, , Spain
Complejo Hospitalario Virgen de la Salud, Toledo, , Spain
Hospital Clinico Universitario de Valencia, Valencia, , Spain
Contact Details
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