Mismatched Donor Lymphocyte Infusions for Relapsed Disease Following Allogeneic Stem Cell Transplantation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Minoo Battiwalla, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00859586
First received: March 10, 2009
Last updated: October 5, 2015
Last verified: August 2014
Results First Received: October 5, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Leukemia, Myeloid, Acute
Leukemia, Lymphoblastic, Acute
Leukemia, Myelocytic, Chronic
Intervention: Device: Miltenyi Magnetic cell sorter for CD3

  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
No text entered.

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
Miltenyi Magnetic Cell Sorter for CD3

Miltenyi Magnetic cell sorter device will be used for CD3 selection of granulocyte colony stimulating factor mobilized allogeneic PBSCT. In stage 1, subjects will receive 1 x 10 to the eight power CD3 cells/kg. In stage II, the dose of CD3+ cells will be increased to 2 x 10 to the eight power cells/kg.

This phase II clinical trial is designed to evaluate a novel non-myeloablative but highly immunosuppressive disease specific conditioning regimen and infusion of unmanipulated lymphocytes from a haplo-identical familial donor in subjects with relapsed disease following matched sibling stem cell transplantation who are not candidates for alternative treatment options. The clinical trial will evaluate recipient survival at six months post-relapse of disease.


Participant Flow:   Overall Study
    Miltenyi Magnetic Cell Sorter for CD3  
STARTED     8  
COMPLETED     4  
NOT COMPLETED     4  
Donors                 4  



  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.
No text entered.

Reporting Groups
  Description
Miltenyi Magnetic Cell Sorter for CD3

Miltenyi Magnetic cell sorter device will be used for CD3 selection of granulocyte colony stimulating factor mobilized allogeneic PBSCT. In stage 1, subjects will receive 1 x 10 to the eight power CD3 cells/kg. In stage II, the dose of CD3+ cells will be increased to 2 x 10 to the eight power cells/kg.

This phase II clinical trial is designed to evaluate a novel non-myeloablative but highly immunosuppressive disease specific conditioning regimen and infusion of unmanipulated lymphocytes from a haplo-identical familial donor in subjects with relapsed disease following matched sibling stem cell transplantation who are not candidates for alternative treatment options. The clinical trial will evaluate recipient survival at six months post-relapse of disease.


Baseline Measures
    Miltenyi Magnetic Cell Sorter for CD3  
Number of Participants  
[units: participants]
  8  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     8  
>=65 years     0  
Gender  
[units: participants]
 
Female     6  
Male     2  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     4  
Not Hispanic or Latino     4  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     8  



  Outcome Measures

1.  Primary:   Overall Recipient Survival at 6-month Post-relapse of Disease   [ Time Frame: 6 months post-relapse of disease ]

2.  Secondary:   Incidence and Severity Induced GvHD, Proportion of DLI Engraftment, Peak Chimerism, Leukemia Response at Days Post DLI, Residual Leukemia Measured by Patient Chimerism, Leukemia Free Survival From Date Relapse, Safety of Mismatched DLI Procedure...   [ Time Frame: Severity of GvHD. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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: Dr. Minoo Battiwalla
Organization: NIH NHLBI
phone: 301-827-0939
e-mail: battiwam@nhlbi.nih.gov


Publications:

Responsible Party: Minoo Battiwalla, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00859586     History of Changes
Other Study ID Numbers: 090087
09-H-0087 ( Other Identifier: NIH NHLBI )
Study First Received: March 10, 2009
Results First Received: October 5, 2015
Last Updated: October 5, 2015
Health Authority: United States: Food and Drug Administration