This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Donor Peripheral Stem Cell Transplant and Donor Natural Killer Cell Transplant After Total-Body Irradiation, Thiotepa, Fludarabine, and Muromonab-CD3 in Treating Patients With Leukemia or Other Blood Diseases

This study has been terminated.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Ann Woolfrey, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00450983
First received: March 20, 2007
Last updated: April 17, 2017
Last verified: April 2017
Results First Received: April 17, 2017  
Study Type: Interventional
Study Design: Masking: No masking;   Primary Purpose: Treatment
Conditions: Graft Versus Host Disease
Leukemia
Myelodysplastic Syndromes
Interventions: Biological: muromonab-CD3
Biological: natural killer cell therapy
Drug: fludarabine phosphate
Drug: methotrexate
Drug: thiotepa
Genetic: gene expression analysis
Other: flow cytometry
Other: immunologic technique
Procedure: allogeneic hematopoietic stem cell transplantation
Procedure: in vitro-treated peripheral blood stem cell transplantation
Radiation: total-body irradiation

  Participant Flow
  Hide Participant Flow

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
Treatment Following total-body irradiation, thiotepa, fludarabine, and muromonab-CD3, participants are given a donor peripheral stem cell transplant and a donor natural killer cell transplant.

Participant Flow:   Overall Study
    Treatment
STARTED   1 
COMPLETED   1 
NOT COMPLETED   0 



  Baseline Characteristics
  Hide Baseline Characteristics

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
Treatment Following total-body irradiation, thiotepa, fludarabine, and muromonab-CD3, participants are given a donor peripheral stem cell transplant and a donor natural killer cell transplant.

Baseline Measures
   Treatment 
Overall Participants Analyzed 
[Units: Participants]
 1 
Age 
[Units: Years]
Median (Full Range)
 1.7 
 (1.7 to 1.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      1 100.0% 
Male      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      1 100.0% 
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      1 100.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Risk of Developing Grades III-IV Acute Graft-vs-host Disease (GVHD)   [ Time Frame: Up to day 100 ]

2.  Secondary:   Risk for Mortality From Infection Before Day 180   [ Time Frame: Up to day 180 ]

3.  Secondary:   Risk for Graft Failure   [ Time Frame: Engraftment documented day +20 ]

4.  Secondary:   Risk for Life-threatening Infections   [ Time Frame: Up to day 100 ]

5.  Secondary:   Concentration of NK, NK-T, T-cells, and Dendritic Cell Subsets in the CD34+ NK/NK-T-enriched Graft   [ Time Frame: Up to 5 years ]

6.  Secondary:   Cytomegalovirus-specific T Cells in Product and Donor Graft   [ Time Frame: Up to 5 years ]

7.  Secondary:   Genotype and Phenotype of Donor Killer Cell Immunoglobulin-like Receptor Expression According to Time After Hematopoietic Stem Cell Transplantation (HSCT)   [ Time Frame: Up to 5 years ]

8.  Secondary:   Reconstitution of NK Function According to Time After HSCT   [ Time Frame: Up to 5 years ]

9.  Secondary:   Expression of NKG2 Ligands of Leukemic Blasts   [ Time Frame: Up to 5 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Ann Woolfrey, MD
Organization: Fred Hutchinson Cancer Research Center
phone: 206-667-4453
e-mail: awoolfre@fredhutch.org



Responsible Party: Ann Woolfrey, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00450983     History of Changes
Other Study ID Numbers: 1965.00
R01AI053193 ( US NIH Grant/Contract Award Number )
P30CA015704 ( US NIH Grant/Contract Award Number )
FHCRC-1965.00
CDR0000533834 ( Registry Identifier: PDQ )
Study First Received: March 20, 2007
Results First Received: April 17, 2017
Last Updated: April 17, 2017