NCT01379209 - Intravenous Administration of RGI-2001 in Patient Undergoing Allogenic Hematopoietic Stem Cell Transplantation (AHSCT) | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

June 30, 2015

Study Completion Date

April 30, 2017

Conditions

Graft Versus Host Disease

Interventions

DRUG

RGI-2001

A single administration of RGI-2001 on Day 0 post AHSCT.

DRUG

Calcineurin Inhibitors

GVHD prophylaxis according to institutional guidelines. Subjects could have received any number/combinations of treatments.

PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

According to institutional guidelines.

DRUG

Conditioning Regimen

Myeloablative preparative treatment according to institutional guidelines. Subjects could have received any number/combinations of treatments.

PROCEDURE

Allogeneic Bone Marrow Transplantation

According to institutional guidelines

DRUG

Methotrexate

DRUG

Mofetil Mycophenolate

DRUG

sirolimus

Administered for GVHD prophylaxis as per institutional guidelines

Trial Locations (6)

33612

H. Lee Moffitt Cancer Center and Research Institute, Tampa

43210

Ohio State University Comprehensive Cancer Center - The James, Columbus

78229

Methodist Healthcare System, San Antonio

93093

UCSD Moores Cancer Research Institute, San Diego

94305

Stanford School of Medicine, Stanford

98109

Fred Hutchinson Cancer Research Center, Seattle

All Listed Sponsors

lead

Regimmune Corporation

INDUSTRY