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Haploidentical Transplant With NK Cell Infusion for Pediatric Acute Leukemia and Solid Tumors

This study has been terminated.
(toxicity)
Sponsor:
Collaborator:
Miltenyi Biotec GmbH
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00582816
First received: December 19, 2007
Last updated: July 17, 2017
Last verified: July 2017
Results First Received: November 2, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Leukemia
Solid Tumors
Interventions: Device: Clinimacs Cell Separation System
Drug: conditioning chemotherapy
Other: DLI

  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
This study enrolled patients with relapsed acute leukemia and very high-risk solid tumors. The last subject was enrolled in October 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Haploidentical Transplant With NK Cell Infusion

Patients underwent a standard pre-transplant evaluation, but will also had blood drawn to evaluate their HLA class I killer immunoglobulin-like receptor (KIR) ligand typing. Parents underwent KIR genotyping and phenotyping, and a donor was selected based on which parent showed the greatest degree of KIR receptor-ligand mismatching. When the donor had been selected he/she underwent a peripheral blood stem cell (PBSC) collection utilizing G-CSF and GM-CSF for stem cell mobilization. The PBSC collection was performed utilizing standard procedures. The PBSC was then be processed in the UW BMT Laboratory in order to deplete the graft of T cells. This was accomplished using the CliniMACS cell separation system. T cell depletion is a standard procedure for patients receiving haploidentical stem cell grafts. The resulting stem cell product were analyzed for T cell, stem cell and NK cell content.

Clinimacs Cell Separation System: Depletion of T-cells


Participant Flow:   Overall Study
    Haploidentical Transplant With NK Cell Infusion
STARTED   9 
COMPLETED   6 [1] 
NOT COMPLETED   3 
Engraftment Failure                3 
[1] "Completed" here means patients stably engrafted with donor cells.



  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
Haploidentical Transplant With NK Cell Infusion

Patients underwent a standard pre-transplant evaluation, but will also had blood drawn to evaluate their HLA class I killer immunoglobulin-like receptor (KIR) ligand typing. Parents underwent KIR genotyping and phenotyping, and a donor was selected based on which parent showed the greatest degree of KIR receptor-ligand mismatching. When the donor had been selected he/she underwent a peripheral blood stem cell (PBSC) collection utilizing G-CSF and GM-CSF for stem cell mobilization. The PBSC collection was performed utilizing standard procedures. The PBSC was then be processed in the UW BMT Laboratory in order to deplete the graft of T cells. This was accomplished using the CliniMACS cell separation system. T cell depletion is a standard procedure for patients receiving haploidentical stem cell grafts. The resulting stem cell product were analyzed for T cell, stem cell and NK cell content.

Clinimacs Cell Separation System: Depletion of T-cells


Baseline Measures
   Haploidentical Transplant With NK Cell Infusion 
Overall Participants Analyzed 
[Units: Participants]
 9 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      9 100.0% 
Between 18 and 65 years      0   0.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      2  22.2% 
Male      7  77.8% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      1  11.1% 
Not Hispanic or Latino      8  88.9% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      8  88.9% 
More than one race      0   0.0% 
Unknown or Not Reported      1  11.1% 
Region of Enrollment 
[Units: Participants]
 
United States   9 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Grade III or IV GVHD   [ Time Frame: Day 100 ]

2.  Primary:   Engraftment Failure   [ Time Frame: 28 days ]

3.  Primary:   Number of Days Until Engraftment Criteria Were Met   [ Time Frame: 28 days ]

4.  Primary:   Mortality Rate   [ Time Frame: 100 days post-transplant ]

5.  Secondary:   NK Expression Levels   [ Time Frame: Up to 12 months ]

6.  Secondary:   Association Between Parental KIR Genotypes and NK Cell Cytotoxicities   [ Time Frame: Day 60 ]

7.  Secondary:   Analysis of NK Cell KIR Expression Over Time   [ Time Frame: Up to 12 months ]


  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
This study involved a small patient cohort; blood samples were to be collected towards the secondary outcome measures. Unfortunately, participants whose blood samples were collected developed GVHD and the tests became uninterpretable.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Ken DeSantes
Organization: University of Wisconsin Carbone Cancer Center
phone: 608-263-8563
e-mail: kbdesantes@pediatrics.wisc.edu



Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00582816     History of Changes
Other Study ID Numbers: BMT06407
H-2006-0297 ( Other Identifier: UW IRB )
2012-0661 ( Other Identifier: UW IRB )
Study First Received: December 19, 2007
Results First Received: November 2, 2016
Last Updated: July 17, 2017