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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
153
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Yale Cancer Center
New Haven, Connecticut, United States
Georgetown University Medical Center
Washington D.C., 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
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
...and 14 more locations
Durable Complete Remission (dCR)
Defined as CR or CRp lasting 180 days or more from time of initial CR or CRp is documented with evidence of subsequent relapse
Time frame: 6 months from time of initial CR or CRp
Overall Survival (OS) following randomization to Iomab-B versus Convetional Care
Patient overall survival
Time frame: Over a 5 year period
Event-Free Survival
Duration of time from randomization to the date of induction treatment failure (ITF), relapse or death
Time frame: Over a 5 year period
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.