General AML

Health Canada grants clearance for phase III SIERRA trial of iomab-b in R/R AML

On 10th May 2017, Health Canada granted clearance for the initiation of the pivotal phase III SIERRA trial of iomab-b (a radio-immunoconjugate of I-131 and a murine monoclonal antibody that targets CD45 [an antigen widely expressed on leukemia cells]) in patients with Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) at Canadian based clinical trial sites.  

The pivotal randomized phase III SIERRA study (NCT02665065) aims to evaluate the efficacy of iomab-B in conjunction with a Reduced Intensity Conditioning (RIC) regimen and protocol-specified allogeneic Hematopoietic Cell Transplant (HCT) in 150 patients (55 years and above) with R/R AML. The primary and secondary endpoints of this study are durable complete remission at 6 months and overall survival at 1 year, respectively.

The clearance granted by Health Canada allows the SIERRA trial to open in approximately 15­–20 clinical trial sites in Canada.

References
  1. GlobeNewswire. Actinium Pharmaceuticals Receives Clearance from Health Canada to Initiate Pivotal Phase 3 SIERRA Trial of Iomab-B. 2017 May 10. https://globenewswire.com/news-release/2017/05/10/981716/0/en/Actinium-Pharmaceuticals-Receives-Clearance-from-Health-Canada-to-Initiate-Pivotal-Phase-3-SIERRA-Trial-of-Iomab-B.html [Accessed 2017 May 10].