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:
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00429416
First received: January 29, 2007
Last updated: December 17, 2013
Last verified: December 2013
Results First Received: July 19, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: 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  
Number of Participants  
[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


No publications provided


Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00429416     History of Changes
Other Study ID Numbers: 04U.115, 2003-68
Study First Received: January 29, 2007
Results First Received: July 19, 2013
Last Updated: December 17, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board