Study of Iomab-B Prior to HCT vs. Conventional Care in Older Subjects With Active, Relapsed or Refractory AML

Official Title

A Multicentre, Pivotal Phase 3 Study of Iomab-B Prior to Allogeneic Hematopoietic Cell Transplantation Versus Conventional Care in Older Subjects With Active, Relapsed or Refractory Acute Myeloid Leukemia

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.

Trial Description

Primary Outcome:

• 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

• Overall Survival (OS) at 1 year from randomization

View this trial on ClinicalTrials.gov