NCT00185679

Haploid Allogeneic Transplant Using the CliniMACS System

A Feasibility Study Evaluating Haploidentical Allogeneic Transplantation Using the CliniMACS System in Patients With Advanced Hematologic Malignancies

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Ginna Laport · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

To assess the proportion of patients with donor neutrophil engraftment within 30 days of allogeneic transplant. To assess the incidence of acute GvHD during the first 100 days after transplantation.

Detailed description

To assess the proportion of patients with donor neutrophil engraftment within 30 days of allogeneic transplant; assess the incidence of acute GvHD during the first 100 days after transplantation; and assess platelet engraftment, graft failure, chronic GvHD, clinical safety, and devise performance.

Conditions

• Acute Myelogenous Leukemia (AML) - Relapsed, Primary Refractory Disease or Poor Risk Factors
• Chronic Myelogenous Leukemia (CML) - Accelerated or Second Chronic Phase
• Myelodysplastic Syndrome (MDS) - High and Intermediate Risk
• Non-Hodgkin's Lymphoma (NHL)
• Chronic Lymphocytic Leukemia (CLL) - Refractory

Interventions

Type	Name	Description
DEVICE	CliniMACS System	The CliniMACS System is a cell selection device consisting of the following components: 1. Computer-controlled instrument; 2. Sterile disposable tubing set (PVC tubing, filters and bags connected to two separation columns containing an iron/plastic matrix) 3. Anti-CD34 antibody reagent (murine monoclonal antibody chemically coupled to a magnetic particle) 4. Wash buffer

Timeline

• Start date: 2001-11-01
• Primary completion: 2009-10-01
• Completion: 2010-02-01
• First posted: 2005-09-16
• Last updated: 2015-03-09
• Results posted: 2015-03-09

Locations

1 site across 1 country: United States