Donor Peripheral Stem Cell Transplant in Treating Patients With Relapsed Acute Myeloid Leukemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT00274846
First received: January 10, 2006
Last updated: November 6, 2012
Last verified: November 2012
Results First Received: July 24, 2009  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Leukemia
Interventions: Biological: aldesleukin
Biological: therapeutic allogeneic lymphocytes
Drug: cyclophosphamide
Drug: fludarabine phosphate
Procedure: in vitro treated peripheral blood stem cell transplantation

  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
Patients With Relapsed/Refractory Acute Myeloid Leukemia Patients who met study criteria - relapsed or refractory acute myelogenous leukemia - and were enrolled.

Participant Flow:   Overall Study
    Patients With Relapsed/Refractory Acute Myeloid Leukemia  
STARTED     21  
COMPLETED     20 [1]
NOT COMPLETED     1  
Did not receive adequate NK cells                 1  
[1] Evaluable patients - received adequate natural killer (NK) 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.
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Reporting Groups
  Description
Patients With Relapsed/Refractory Acute Myeloid Leukemia Patients who met study criteria - relapsed or refractory acute myelogenous leukemia - and were enrolled.

Baseline Measures
    Patients With Relapsed/Refractory Acute Myeloid Leukemia  
Number of Participants  
[units: participants]
  21  
Age  
[units: participants]
 
<=18 years     3  
Between 18 and 65 years     17  
>=65 years     1  
Age  
[units: years]
Mean ± Standard Deviation
  40  ± 18.8  
Gender  
[units: participants]
 
Female     10  
Male     11  
Region of Enrollment  
[units: participants]
 
United States     21  



  Outcome Measures
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1.  Primary:   Number of Patients With Natural Killer (NK) Cell Expansion   [ Time Frame: Study Day 14 ]

2.  Secondary:   Number of Patients With Complete Remission   [ Time Frame: Day 28-35 ]

3.  Secondary:   Median Time to Disease Relapse (Months)   [ Time Frame: From 1st Day of treatment until death or receipt of bone marrow transplant. ]

4.  Secondary:   Overall Survival Time of Patients With Complete Remission   [ Time Frame: From Day 1 of Treatment until death or patient received bone marrow transplant. ]

5.  Secondary:   Number of Patients With Complete Remission and Natural Killer Cell Expansion   [ Time Frame: Day 14 ]


  Serious Adverse Events


  Other Adverse Events


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


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.  


Results Point of Contact:  
Name/Title: Jeffrey Miller, M.D.
Organization: Masonic Cancer Center, University of Minnesota
phone: 612-625-7409
e-mail: mille011@umn.edu


No publications provided


Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00274846     History of Changes
Other Study ID Numbers: CDR0000450852, UMN-2004LS073, UMN-MT2004-25
Study First Received: January 10, 2006
Results First Received: July 24, 2009
Last Updated: November 6, 2012
Health Authority: United States: Food and Drug Administration