Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Acute Myelogenous Leukemia
  • Acute Myeloid Leukemia
  • AML
  • Bone Marrow Transplant
  • Leukemia, Acute Myelogenous
  • Leukemia Acute Myeloid
  • Leukemia Myeloid Acute
  • Myelogenous Leukemia, Acute
  • Myeloid Leukemia, Acute
Type
Interventional
Phase
Phase 3
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 55 years and 125 years
Gender
Both males and females

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 ...

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.

Tracking Information

NCT #
NCT02665065
Collaborators
Not Provided
Investigators
Study Director: Mark Berger, MD Actinium Pharmaceuticals