NCT00429416

Research Study to Determine if an Experimental Agent, LLME Can Decrease the Incidence and Severity of Graft-Versus-Host-Disease (GVHD) Following Blood (Hematopoietic) Stem Cell Transplantation

A Phase I/II Study of Llme Treated Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Hematological Malignancies

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to determine if an experimental agent, LLME can decrease the incidence and severity of Graft-Versus-Host-Disease (GVHD) following blood (hematopoietic) stem cell transplantation

Detailed description

We believe that the risks of allogeneic transplant can be drastically reduced if the following criteria can be met: (1) consistent engraftment, (2) little or no GVHD with the ability to rapidly withdraw immune suppression, (3) rapid recovery of CD4 counts to levels greater than 200 cells/micro liter. Our prior (ongoing) trial attempts to address how LLME treated T cells given as donor lymphocyte infusion (DLI) can address points 2 and 3 above. The current study addresses how treatment of the CD34- fraction of the graft attempts to address points 1 and 2 (and to a lesser extent point 3) above. We believe that if these points can be consistently achieved that the mortality of allogeneic HSCT may be reduced to levels more akin to those of autologous HSCT. We propose to test the hypothesis that LLME-treated T cells will be safe with regard to reducing GVHD or other infusion related toxicities and that their administration as part of the transplant will facilitate engraftment. We believe that this approach will ultimately be an important step in a variety of transplant settings ranging from matched siblings to haplodisparate donors.

Conditions

• Hematologic Malignancies

Interventions

Type	Name	Description
DRUG	L-leucyl-L-leucine Methyl Ester (LLME)	Infusion of L-leucyl-L-leucine methyl ester (LLME) treated donor white blood cells
DRUG	Fludarabine	Fludarabine 30 mg/m2 prior to HSCT infusion
DRUG	Cytarabine	Cytarabine 2gm/m2 prior to HSCT infusion
DRUG	Cyclophosphamide	Cyclophosphamide 1gm/m2 prior to HSCT infusion
DRUG	Tacrolimus	Tacrolimus given before and after HSCT infusion
DRUG	Mesna	Mesna 1gm/m2/day given prior to HSCT infusion.
BIOLOGICAL	Granulocyte Macrophage Colony-Stimulating Factor (GM-CSF)	GM-CSF given post HSCT infusion
PROCEDURE	Hematopoietic stem cell transplantation (HSCT)	CD34 selected allogeneic stem cell infusion with 5x104/kg untreated T cells

Timeline

• Start date: 2004-03-01
• Primary completion: 2008-12-01
• Completion: 2009-05-01
• First posted: 2007-01-31
• Last updated: 2016-11-29
• Results posted: 2013-12-10

Locations

1 site across 1 country: United States