CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 14 enrolled
Drug / intervention
L-leucyl-L-leucine Methyl Ester (LLME) +7 moredrug
Likely dose
Fludarabine 30 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00429416
NCT00429416Phase 2Completed
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A Phase I/II Study of Llme Treated Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Hematological Malignancies

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·interventional·Posted Jan 31, 2007·Updated Nov 29, 2016

In Brief

A Phase 2 clinical trial evaluating L-leucyl-L-leucine Methyl Ester (LLME), Fludarabine, and 6 other interventions for Hematologic Malignancies. Completed, enrolled 14 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHematologic Malignancies
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 31, 2007
Enrollment StartMar 1, 2004
Primary CompletionDec 1, 2008
Study CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 19.4 years ago

Interventions

L-leucyl-L-leucine Methyl Ester (LLME)drug

Infusion of L-leucyl-L-leucine methyl ester (LLME) treated donor white blood cells

Fludarabinedrug

Fludarabine 30 mg/m2 prior to HSCT infusion

Cytarabinedrug

Cytarabine 2gm/m2 prior to HSCT infusion

Cyclophosphamidedrug

Cyclophosphamide 1gm/m2 prior to HSCT infusion

Tacrolimusdrug

Tacrolimus given before and after HSCT infusion

Mesnadrug

Mesna 1gm/m2/day given prior to HSCT infusion.

Granulocyte Macrophage Colony-Stimulating Factor (GM-CSF)biological

GM-CSF given post HSCT infusion

Hematopoietic stem cell transplantation (HSCT)procedure

CD34 selected allogeneic stem cell infusion with 5x104/kg untreated T cells