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Chemotherapy, Total-Body Irradiation, Donor Natural Killer Cell Infusion, Aldesleukin, and UCB Transplant in Treating Patients With Relapsed or Refractory AML

This study has been terminated.
(Due to graft failure.)
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT00871689
First received: March 27, 2009
Last updated: July 18, 2012
Last verified: July 2012
History of Changes
Results First Received: June 11, 2012  
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
Drug: cyclophosphamide
Drug: fludarabine phosphate
Procedure: umbilical cord blood transplantation
Radiation: total-body irradiation

  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
Study entry was open to patients aged 0 to 45 years regardless of gender or ethnic background at the University of Minnesota, Masonic Cancer Center.

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 Receiving Double Umbilical Cord Blood Transplant Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.

Participant Flow:   Overall Study
    Patients Receiving Double Umbilical Cord Blood Transplant  
STARTED     2  
COMPLETED     2  
NOT COMPLETED     0  



  Baseline Characteristics
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Reporting Groups
  Description
Patients Receiving Double Umbilical Cord Blood Transplant Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.

Baseline Measures
    Patients Receiving Double Umbilical Cord Blood Transplant  
Number of Participants  
[units: participants]
 		  2  
Age  
[units: participants]
 		 
<=18 years     2  
Between 18 and 65 years     0  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation 		  10.5  ± 2.1  
Gender  
[units: participants]
 		 
Female     0  
Male     2  
Region of Enrollment  
[units: participants]
 		 
United States     2  



  Outcome Measures
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1.  Primary:   Number of Patients With Neutrophil Engraftment   [ Time Frame: Day 42 ]
  Show Outcome Measure 1

2.  Primary:   Number of Patients With Grade III-IV Acute Graft-Versus-Host (GVHD) Disease   [ Time Frame: Day 100 Post Transplant ]
  Show Outcome Measure 2

3.  Secondary:   Incidence of Primary Graft Failure   [ Time Frame: Day 42 ]
  Hide Outcome Measure 3

Measure Type Secondary
Measure Title Incidence of Primary Graft Failure
Measure Description Incidence of graft failure defined as an absolute neutrophil count of less than 500/uL and a bone marrow that is less than 5% cellular (marrow aplasia) on day 42.
Time Frame Day 42  
Safety Issue Yes  

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 Receiving Double Umbilical Cord Blood Transplant Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.

Measured Values
    Patients Receiving Double Umbilical Cord Blood Transplant  
Number of Participants Analyzed  
[units: participants]
 		  2  
Incidence of Primary Graft Failure  
[units: Participants]
 		  1  

No statistical analysis provided for Incidence of Primary Graft Failure



4.  Secondary:   Number of Patients With Acute Graft-Versus-Host (GVHD) Disease   [ Time Frame: Day 100 Post Transplant ]
  Show Outcome Measure 4

5.  Secondary:   Number of Patients With Transplant-Related Death (TRD)   [ Time Frame: 1 Year Post Transplant ]
  Show Outcome Measure 5

6.  Secondary:   Number of Patients With Complete Remission of Disease   [ Time Frame: Day 100 ]
  Show Outcome Measure 6

7.  Secondary:   Median Overall Survival   [ Time Frame: Month 6 ]
  Show Outcome Measure 7

8.  Secondary:   Number of Patients With Successful Natural Killer Expansion   [ Time Frame: Day 72 Post Transplant ]
  Show Outcome Measure 8


  Serious Adverse Events
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  Other Adverse Events
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  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
Quantitative, phenotypic and functional assessment of the in vivo expanded UCB-derived NK cells on Day 72 were not performed. Patients were not well enough to provide research samples.  


Results Point of Contact:  
Name/Title: Michael Verneris, M.D.
Organization: Masonic Cancer Center, University of Minnesota
phone: 612-626-2961
e-mail: verneris@umn.edu


No publications provided


Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00871689     History of Changes
Other Study ID Numbers: 2008LS110, MT2008-36, 0810M51781
Study First Received: March 27, 2009
Results First Received: June 11, 2012
Last Updated: July 18, 2012
Health Authority: United States: Food and Drug Administration