A Multicenter, Pivotal Phase 3 Study of Iomab-B Prior to Allogeneic Hematopoietic Cell Transplant Versus Conventional Care in Older Subjects With Active, Relapsed or Refractory Acute Myeloid Leukemia (AML) (SIERRA)

NCT02665065 Phase 3 ACTIVE_NOT_RECRUITING

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).

Details

Lead sponsor	Actinium Pharmaceuticals
Phase	Phase 3
Status	ACTIVE_NOT_RECRUITING
Enrolment	153
Start date	2016-06
Completion	2026-12

Conditions

• Acute Myeloid Leukemia
• Leukemia, Acute Myeloid
• Myeloid Leukemia, Acute
• Leukemia, Myeloid, Acute
• Acute Myelogenous Leukemia
• Leukemia, Acute Myelogenous
• Myelogenous Leukemia, Acute
• AML
• Bone Marrow Transplant

Interventions

• Iomab-B
• Conventional Care
• HCT

Primary outcomes

• Durable Complete Remission (dCR) — 6 months from time of initial CR or CRp
  Defined as CR or CRp lasting 180 days or more from time of initial CR or CRp is documented with evidence of subsequent relapse

Countries

United States, Canada