NCT00890500

Safety and Efficacy of ProHema Modulated Umbilical Cord Blood Units in Subjects With Hematologic Malignancies.

A Phase I Study of Reduced Intensity, Sequential Double Umbilical Cord Blood Transplantation Using ProHema Modulated Umbilical Cord Blood Units in Subjects With Hematological Malignancies.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Fate Therapeutics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to determine the safety and efficacy of a reduced intensity conditioning regimen during a double umbilical cord blood unit transplant with one of the cord blood units modulated with ProHema.

Detailed description

The purpose of this research study is to determine the safety and efficacy of a reduced intensity conditioning regimen during a double umbilical cord blood unit transplant with one of the cord blood units modulated with ProHema. -As part of this research study cord units will be modulated in the laboratory with ProHema before it is given to the participant. Two different treatment groups will be tested. Group 1: will have the second cord blood unit modulated with ProHema; Group 2: will have the first cord blood unit modulated with ProHema.

Conditions

• Hematologic Malignancies
• Allogeneic Stem Cell Transplantation

Interventions

Type	Name	Description
DRUG	Fludarabine	30mg/m2/day IV x 6 days
DRUG	Melphalan	100 mg/m2/day IV x 1 day
DRUG	Antithymocyte Globulin	1mg/kg/day x 4 days
DRUG	Sirolimus	GVHD Prophylaxis: Target range 3-12 ng/ml
DRUG	Tacrolimus	GVHD Prophylaxis: Target range 5-10 ng/ml

Timeline

• Start date: 2011-01-01
• Primary completion: 2013-05-01
• Completion: 2013-10-01
• First posted: 2009-04-29
• Last updated: 2013-10-08

Locations

2 sites across 1 country: United States