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.
Bone marrow transplant,
Acute myeloid leukemia,
Acute Myelogenous Leukemia (AML),
acute myelogenous leukemia,
acute myeloblastic leukemia,
bone marrow transplantation,
bone marrow graft
Total body irradiation,
Mycofenolate mofetil (MMF),
Cyclosporine or Tacrolimus
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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