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Stem Cell Transplantation and T-Cell Add-Back to Treat Bone Marrow Malignancies

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
John Barrett, M.D., National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00079391
First received: March 8, 2004
Last updated: April 30, 2013
Last verified: April 2013
History of Changes
Results First Received: April 20, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Hematologic Malignancies
Bone Marrow Transplant Rejection
Intervention: Device: allogeneic hematopoietic stem cell transplantation

  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
Bone Marrow Transplantation Using "Nexell Isolex 300i" Bone marrow stem cell transplant program to improve the outcome of allogeneic Bone Marrow Transplant for hematologic malignancies. Immunosuppression including cyclosporine will be given six days prior to transplant up to 21 days post transplant. cluster of differentiation 34 (CD34) selection and T cell depletion using Isolex 300i immuno-magnetic cell selection and immunosuppression during peri- transplant.

Participant Flow:   Overall Study
    Bone Marrow Transplantation Using "Nexell Isolex 300i"  
STARTED     50 [1]
COMPLETED     49  
NOT COMPLETED     1  
Withdrawal by Subject                 1  
[1] 1 of these withdrew after consent.



  Baseline Characteristics
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Reporting Groups
  Description
Bone Marrow Transplantation Using Nexell Isolex 300i Bone marrow stem cell transplant program to improve the outcome of allogeneic Bone Marrow Transplant for hematologic malignancies. Immunosuppression including cyclosporine will be given six days prior to transplant up to 21 days post transplant. CD34 selection and T cell depletion using Isolex 300i immuno-magnetic cell selection and immunosuppression during peri- transplant.

Baseline Measures
    Bone Marrow Transplantation Using Nexell Isolex 300i  
Number of Participants  
[units: participants]
 		  50  
Age  
[units: participants]
 		 
<=18 years     4  
Between 18 and 65 years     46  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation 		  33  ± 10  
Gender  
[units: participants]
 		 
Female     28  
Male     22  
Region of Enrollment  
[units: participants]
 		 
United States     50  



  Outcome Measures
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1.  Primary:   The Proportion of Patients Who Develop Full Donor T Cell Chimerism at Day 30   [ Time Frame: Day 30 ]
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2.  Secondary:   Overall Survival   [ Time Frame: at 5 years post transplant ]
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3.  Secondary:   Non Relapse Mortality.   [ Time Frame: at 5 years post transplant ]
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4.  Secondary:   Cumulative Incidence of Relapse   [ Time Frame: at 5 years post transplant ]
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5.  Secondary:   Acute Graft Versus Host Disease (Before Day 60 T Cell Add Back)   [ Time Frame: First 60 days ]
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6.  Secondary:   Acute GVHD Overall   [ Time Frame: First 100 days ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
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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Results Point of Contact:  
Name/Title: A. John Barrett
Organization: NIH National Heart, Lung and Blood Institute
phone: 301-402-4170
e-mail: barrettjj@nhlbi.nih.gov


Publications of Results:

Publications automatically indexed to this study:


Responsible Party: John Barrett, M.D., National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00079391     History of Changes
Obsolete Identifiers: NCT00076778
Other Study ID Numbers: 040112, 04-H-0112
Study First Received: March 8, 2004
Results First Received: April 20, 2011
Last Updated: April 30, 2013
Health Authority: United States: Food and Drug Administration