NCT00429416View on ClinicalTrials.gov

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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

March 31, 2004

Primary Completion Date

December 31, 2008

Study Completion Date

May 31, 2009

Conditions
Hematologic Malignancies
Interventions
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

Trial Locations (1)

19107

Thomas Jefferson University', Philadelphia

All Listed Sponsors
lead

Sidney Kimmel Cancer Center at Thomas Jefferson University

OTHER

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 | Biotech Hunter | Biotech Hunter