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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00429416
First Posted: January 31, 2007
Last Update Posted: November 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )
Results First Submitted: July 19, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Hematologic Malignancies
Interventions: Drug: L-leucyl-L-leucine Methyl Ester (LLME)
Drug: Fludarabine
Drug: Cytarabine
Drug: Cyclophosphamide
Drug: Tacrolimus
Drug: Mesna
Biological: Granulocyte Macrophage Colony-Stimulating Factor (GM-CSF)
Procedure: Hematopoietic stem cell transplantation (HSCT)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
LLME to Decrease GVHD Following HSC T

To determine if an experimental agent, L-leucyl-L-leucine Methyl Ester (LLME), can decrease the incidence and severity of Graft-Versus-Host-Disease (GVHD) following hematopoietic stem cell transplantation (HSCT).

Treatment Outline:

Day -6: Fludarabine 30 mg/m2 IV, Cytarabine 2 gm/m2 IV Day -5: Fludarabine 30 mg/m2 IV, Cyclophosphamide 1 gm/m2 IV, Mesna 1 gm/m2 IV Day -4: Fludarabine 30 mg/m2 IV, Cytarabine 2 gm/m2 IV, Mesna 1 gm/m2 IV Day -3: Fludarabine 30 mg/m2 IV, Cyclophosphamide 1 gm/m2 IV, Mesna 1 gm/m2 IV Day -2: Fludarabine 30 mg/m2 IV, Cytarabine 2 gm/m2 IV, Mesna 1 gm/m2 IV Day -1: Rest day Day 0: CD34 selected allogeneic stem cell infusion with 5x104/kg untreated T cells Day 1: Infusion of LLME treated donor CD34 – cells


Participant Flow:   Overall Study
    LLME to Decrease GVHD Following HSC T
STARTED   14 
COMPLETED   13 
NOT COMPLETED   1 
Death                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
LLME to Decrease GVHD Following HSC T To determine if an experimental agent, LLME, can decrease the incidence and severity of Graft-Versus-Host-Disease (GVHD) following hematopoietic stem cell transplantation (HSCT).

Baseline Measures
   LLME to Decrease GVHD Following HSC T 
Overall Participants Analyzed 
[Units: Participants]
 14 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   13 
>=65 years   1 
Age 
[Units: Years]
Mean (Standard Deviation)
 54.65  (9.74) 
Gender 
[Units: Participants]
 
Female   6 
Male   8 
Region of Enrollment 
[Units: Participants]
 
United States   14 


  Outcome Measures
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1.  Primary:   Safety of CD34+ Stem Cell Infusions Followed by LLME as Measured by 100-Day Mortality   [ Time Frame: Through 100 days post-transplant or death ]

2.  Secondary:   Rate of Engraftment of Non-Myeloablative Transplants   [ Time Frame: Through 30 days post-transplant ]

3.  Secondary:   Incidence of Grade II-IV Acute Graft-Versus-Host-Disease (GVHD)   [ Time Frame: Through 24 months post-treatment ]

4.  Secondary:   Rate of Serious Infectious Complications   [ Time Frame: Through 3 months post-transplant ]

5.  Secondary:   Number of Patients Who Achieve a CD4 Count > 200/Micro-liters   [ Time Frame: Through 60 Days Post Transplant ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: John Wagner, MD
Organization: Thomas Jefferson University
phone: 215-955-8874
e-mail: John.Wagner@jefferson.edu



Responsible Party: Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )
ClinicalTrials.gov Identifier: NCT00429416     History of Changes
Other Study ID Numbers: 04U.115
2003-68 ( Other Identifier: CCRRC )
First Submitted: January 29, 2007
First Posted: January 31, 2007
Results First Submitted: July 19, 2013
Results First Posted: December 10, 2013
Last Update Posted: November 29, 2016