ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00274846
Recruitment Status : Completed
First Posted : January 11, 2006
Results First Posted : September 7, 2009
Last Update Posted : December 28, 2017
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (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

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
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

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
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 
Overall Participants Analyzed 
[Units: Participants]
 21 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      3  14.3% 
Between 18 and 65 years      17  81.0% 
>=65 years      1   4.8% 
Age 
[Units: Years]
Mean (Standard Deviation)
 40  (18.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      10  47.6% 
Male      11  52.4% 
Region of Enrollment 
[Units: Participants]
 
United States   21 


  Outcome Measures

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


  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

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


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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00274846     History of Changes
Other Study ID Numbers: CDR0000450852
UMN-2004LS073 ( Other Identifier: Clinical Trials Office, University of Minnesota )
UMN-MT2004-25 ( Other Identifier: Blood and Marrow Transplantation Program )
First Submitted: January 10, 2006
First Posted: January 11, 2006
Results First Submitted: July 24, 2009
Results First Posted: September 7, 2009
Last Update Posted: December 28, 2017