Spots Global Cancer Trial Database for Study of Iomab-B vs. Conventional Care in Older Subjects With Active, Relapsed or Refractory Acute Myeloid Leukemia
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Trial Identification
Brief Title: Study of Iomab-B vs. Conventional Care in Older Subjects With Active, Relapsed or Refractory Acute Myeloid Leukemia
Official Title: A Multicenter, Pivotal Phase 3 Study of Iomab-B Prior to Allogeneic Hematopoietic Cell Transplant Versus Conventional Care in Older Subjects With Active, Relapsed or Refractory Acute Myeloid Leukemia (AML)
Study ID: NCT02665065
Study Description
Brief Summary: The primary objective of this study is to demonstrate the efficacy of Iomab-B, in conjunction with a Reduced Intensity Conditioning (RIC) regimen and protocol-specified allogeneic hematopoietic stem cell transplant (HCT), versus Conventional Care in patients with Active, Relapsed or Refractory Acute Myeloid Leukemia (AML).
Detailed Description: SIERRA is a pivotal Phase 3 randomized controlled study of Iomab-B in Relapsed or Refractory AML patients. The SIERRA trial has a primary endpoint of durable Complete Remission (dCR) at six months and a secondary endpoint of overall survival following randomization to Iomab-B, as well as Event-Free Survival. Iomab-B is intended to prepare and condition patients for a bone marrow transplant, also referred to as a hematopoietic stem cell transplant, in a potentially safer and more efficacious manner than intensive chemotherapy conditioning that is the current standard of care in bone marrow transplant conditioning.
Eligibility
Minimum Age: 55 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
Yale Cancer Center, New Haven, Connecticut, United States
Georgetown University Medical Center, Washington, District of Columbia, United States
Mayo Clinic, Jacksonville, Florida, United States
Loyola University Medical Center, Maywood, Illinois, United States
University of Iowa, Iowa City, Iowa, United States
The University of Kansas Cancer Center, Westwood, Kansas, United States
Mayo Clinic, Rochester, Minnesota, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Weill Cornell Medicine, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Stony Brook University, Stony Brook, New York, United States
University of North Carolina Hospital, Chapel Hill, North Carolina, United States
University Hospital of Cleveland Seidman Cancer Center, Cleveland, Ohio, United States
The Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Oregon Health & Science University, Portland, Oregon, United States
Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
MD Anderson Cancer Center, Houston, Texas, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
University of Ottawa, Ottawa, Ontario, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Contact Details
Name: Avinash Desai, MD
Affiliation: Actinium Pharmaceuticals
Role: STUDY_CHAIR
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