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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

NCT00429416 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2016-11-29

Study results available
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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

Conditions

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

Sponsors & Collaborators

  • Sidney Kimmel Cancer Center at Thomas Jefferson University

    lead OTHER

Principal Investigators

  • John Wagner, MD · Thomas Jefferson University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-03-31
Primary Completion
2008-12-31
Completion
2009-05-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00429416 on ClinicalTrials.gov