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Prophylactic White Cell Transfusions Versus Therapeutic White Cell Transfusions in Patients With Leukemia

This study has been terminated.
(Low Recruitment)
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01204788
First received: September 15, 2010
Last updated: May 28, 2015
Last verified: May 2015
Results First Received: May 28, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Leukemia
Interventions: Procedure: Prophylactic White Cell Transfusion
Procedure: Therapeutic White Cell Transfusion

  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
Recruitment Period: September 15, 2010 to January 2, 2013. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One participant was not treated and is therefore excluded from the trial.

Reporting Groups
  Description
Arm 1 (Prophylactic Arm) Prophylactic Treatment (standard of care prophylactic antibiotics) + Prophylactic White Cell Transfusion. Radiated white blood cell transfusions 2-3 times each week, or daily if infection develops
Arm 2 (Therapeutic Arm) Prophylactic Treatment (standard of care prophylactic antibiotics) + Therapeutic White Cell Transfusion. Radiated white blood cell transfusions daily only with infection (or persistent fever)

Participant Flow:   Overall Study
    Arm 1 (Prophylactic Arm)   Arm 2 (Therapeutic Arm)
STARTED   1   3 
COMPLETED   0   0 
NOT COMPLETED   1   3 



  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
Arm 1 (Prophylactic Arm) Prophylactic Treatment (standard of care prophylactic antibiotics) + Prophylactic White Cell Transfusion. Radiated white blood cell transfusions 2-3 times each week, or daily if infection develops
Arm 2 (Therapeutic Arm) Prophylactic Treatment (standard of care prophylactic antibiotics) + Therapeutic White Cell Transfusion. Radiated white blood cell transfusions daily only with infection (or persistent fever)
Total Total of all reporting groups

Baseline Measures
   Arm 1 (Prophylactic Arm)   Arm 2 (Therapeutic Arm)   Total 
Overall Participants Analyzed 
[Units: Participants]
 1   3   4 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   1   1   2 
>=65 years   0   2   2 
Gender 
[Units: Participants]
     
Female   1   0   1 
Male   0   3   3 
Region of Enrollment 
[Units: Participants]
     
United States   1   3   4 


  Outcome Measures

1.  Primary:   Number of Participants With Infection   [ Time Frame: Blood draw 2-3 times a week while hospitalized, weekly thereafter. Participant to remain on study 42 days after transfusion. ]


  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: Emil Freireich, MD, Professor, Department of Medical Education
Organization: University of Texas (UT) MD Anderson Cancer Center
phone: 713-745-2723
e-mail: CR_Study_Registration@mdanderson.org



Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01204788     History of Changes
Other Study ID Numbers: 2010-0468
NCI-2012-01795 ( Registry Identifier: NCI CTRP )
Study First Received: September 15, 2010
Results First Received: May 28, 2015
Last Updated: May 28, 2015
Health Authority: United States: Institutional Review Board