Haploid Allogeneic Transplant Using the CliniMACS System

This study has been terminated.
(This study was superseded by the subsequent study IRB-15919 (NCT01050764))
Sponsor:
Information provided by (Responsible Party):
Ginna Laport, Stanford University
ClinicalTrials.gov Identifier:
NCT00185679
First received: September 12, 2005
Last updated: February 26, 2015
Last verified: February 2015
Results First Received: February 26, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Acute Myelogenous Leukemia (AML) - Relapsed, Primary Refractory Disease or Poor Risk Factors
Chronic Myelogenous Leukemia (CML) - Accelerated or Second Chronic Phase
Myelodysplastic Syndrome (MDS) - High and Intermediate Risk
Non-Hodgkin's Lymphoma (NHL)
Chronic Lymphocytic Leukemia (CLL) - Refractory
Intervention: Device: CliniMACS System

  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
No text entered.

Reporting Groups
  Description
Haploidentical Allogeneic Transplant Using CliniMACS System

The CliniMACS cell selection system (Miltenyi Biotec) will be used to enrich hematopoietic stem cells from related, haploidentical, HLA-matched donors, who matched on the A,B,C and DRB1, DQ loci.

CliniMACS System: The CliniMACS System is a cell selection device consisting of the following components:

  1. Computer-controlled instrument;
  2. Sterile disposable tubing set (PVC tubing, filters and bags connected to two separation columns containing an iron/plastic matrix)
  3. Anti-CD34 antibody reagent (murine monoclonal antibody chemically coupled to a magnetic particle)
  4. Wash buffer

Participant Flow:   Overall Study
    Haploidentical Allogeneic Transplant Using CliniMACS System  
STARTED     13  
COMPLETED     13  
NOT COMPLETED     0  



  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 Allogeneic Transplant Using CliniMACS System

The CliniMACS cell selection system (Miltenyi Biotec) will be used to enrich hematopoietic stem cells from related, haploidentical, HLA-matched donors, who matched on the A,B,C and DRB1, DQ loci.

The CliniMACS System is a cell selection device consisting of the following components:

  1. Computer-controlled instrument;
  2. Sterile disposable tubing set (PVC tubing, filters and bags connected to two separation columns containing an iron/plastic matrix)
  3. Anti-CD34 antibody reagent (murine monoclonal antibody chemically coupled to a magnetic particle)
  4. Wash buffer

Baseline Measures
    Haploidentical Allogeneic Transplant Using CliniMACS System  
Number of Participants  
[units: participants]
  13  
Age  
[units: years]
Median (Full Range)
  27  
  (21 to 51)  
Gender  
[units: participants]
 
Female     6  
Male     7  



  Outcome Measures
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1.  Primary:   Neutrophil Engraftment   [ Time Frame: 30 days post-transplant ]

2.  Secondary:   Acute GvHD (Grade II-IV)   [ Time Frame: within 100 days post-transplant ]

3.  Secondary:   Platelet Recovery   [ Time Frame: 40 days ]


  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:  
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: Ginna G Laport, MD
Organization: Stanford Cancer Institute
phone: 650-723-8222 ext 13911
e-mail: ginna.laport@stanford.edu



Responsible Party: Ginna Laport, Stanford University
ClinicalTrials.gov Identifier: NCT00185679     History of Changes
Other Study ID Numbers: IRB-12600
BMT123 ( Other Identifier: OnCore )
NCI-2011-00424 ( Other Identifier: NCI PDQ )
77453 ( Other Identifier: Historic IRB SQL database number )
Study First Received: September 12, 2005
Results First Received: February 26, 2015
Last Updated: February 26, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
United States: Data and Safety Monitoring Board