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
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|ClinicalTrials.gov Identifier: NCT00429416|
Recruitment Status : Completed
First Posted : January 31, 2007
Results First Posted : December 10, 2013
Last Update Posted : November 29, 2016
|Condition or disease||Intervention/treatment||Phase|
|Hematologic Malignancies||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)||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study of Llme Treated Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Hematological Malignancies|
|Study Start Date :||March 2004|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||May 2009|
Experimental: 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).
Drug: L-leucyl-L-leucine Methyl Ester (LLME)
Infusion of L-leucyl-L-leucine methyl ester (LLME) treated donor white blood cells
Other Name: LLMEDrug: Fludarabine
Fludarabine 30 mg/m2 prior to HSCT infusion
Other Names:Drug: Cytarabine
Cytarabine 2gm/m2 prior to HSCT infusion
Other Names:Drug: Cyclophosphamide
Cyclophosphamide 1gm/m2 prior to HSCT infusion
Other Names:Drug: Tacrolimus
Tacrolimus given before and after HSCT infusion
Other Names:Drug: Mesna
Mesna 1gm/m2/day given prior to HSCT infusion.
Other Names:Biological: Granulocyte Macrophage Colony-Stimulating Factor (GM-CSF)
GM-CSF given post HSCT infusion
Other Name: GM-CSFProcedure: Hematopoietic stem cell transplantation (HSCT)
CD34 selected allogeneic stem cell infusion with 5x104/kg untreated T cells
Other Name: HSCT
- Safety of CD34+ Stem Cell Infusions Followed by LLME as Measured by 100-Day Mortality [ Time Frame: Through 100 days post-transplant or death ]
Determine the safety of CD34+ stem cell infusions followed by the LLME treated CD34- fraction. This includes monitoring the patients for any side effects associated with the LLME treated cell infusion or any other unexpected adverse events.
This regimen will be gauged as to its safety using 100 day mortality as the measured endpoint. Deaths from all causes will be included.
- Rate of Engraftment of Non-Myeloablative Transplants [ Time Frame: Through 30 days post-transplant ]Determine the engraftment rate of non-myeloablative transplants using CD34+ stem cells and LLME treated CD34- products.
- Incidence of Grade II-IV Acute Graft-Versus-Host-Disease (GVHD) [ Time Frame: Through 24 months post-treatment ]Determine the incidence of grade II-IV acute GVHD after administration of grafts when combined with Cyclosporine/Mycophenolate Mofetil for GVHD prophylaxis. GVHD assessments occur daily as an in patient and at each out patient visit.
- Rate of Serious Infectious Complications [ Time Frame: Through 3 months post-transplant ]
Determine the rate of serious infectious complications. A serious infection will be defined as any requiring hospitalization or parenteral therapy.
CD4 counts will be measured monthly for the first 3 months after transplant.
- Number of Patients Who Achieve a CD4 Count > 200/Micro-liters [ Time Frame: Through 60 Days Post Transplant ]Determine the number of patients who achieve a CD4 count > 200/micro-liters by 60 days after transplant.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00429416
|United States, Pennsylvania|
|Thomas Jefferson University`|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||John Wagner, MD||Thomas Jefferson University|