Trials / Active Not Recruiting

Active Not RecruitingNCT02665065

Study of Iomab-B vs. Conventional Care in Older Subjects With Active, Relapsed or Refractory Acute Myeloid Leukemia

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)

Status: Active Not Recruiting
Phase: Phase 3
Study type: Interventional
Enrollment: 153 (actual)

Sponsor: Actinium Pharmaceuticals · Industry
Sex: All
Age: 55 Years
Healthy volunteers: Not accepted

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 in patients with Active, Relapsed or Refractory Acute Myeloid Leukemia (AML).

Detailed 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 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.

Conditions

Interventions

Type	Name	Description
DRUG	Iomab-B
DRUG	Conventional Care
PROCEDURE	HCT

Timeline

Start date: 2016-06-01
Primary completion: 2022-06-01
Completion: 2026-12-01
First posted: 2016-01-27
Last updated: 2023-07-19

Locations

24 sites across 2 countries: United States, Canada

Source: ClinicalTrials.gov record NCT02665065. Inclusion in this directory is not an endorsement.