Haploidentical Natural Killer (NK) Cells With Epratuzumab for Relapsed Acute Lymphoblastic Leukemia (ALL)

This study has been terminated.
(Slow accrual)
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00941928
First received: July 16, 2009
Last updated: May 19, 2014
Last verified: May 2014
Results First Received: May 22, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Leukemia
Pediatric Cancer
Interventions: Drug: Epratuzumab
Drug: Fludarabine
Drug: Cyclophosphamide
Drug: Mesna
Procedure: Infusion of NK cells
Drug: Interleukin-2

  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: July 14, 2009 to December 6, 2010. All recruitment occurred 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
No text entered.

Reporting Groups
  Description
Haploidentical NK Cells + Epratuzumab Haploidentical donor-derived NK cell infusion, Epratuzumab 360 mg/m^2 once a day by vein (IV) on Day -4, Day -1 and Days 3, 6, 10, 13 and 17, and low-dose interleukin-2 (IL-2) Subcutaneous injections three times a week for 9 doses on Days 0 to 21; Fludarabine 25 mg/m^2 once a day IV on Day -6 through Day -2 over 30 minutes; Cyclophosphamide 60 mg/kg once a day IV on Days -5 and -4 over 2 hours.

Participant Flow:   Overall Study
    Haploidentical NK Cells + Epratuzumab  
STARTED     2  
COMPLETED     0  
NOT COMPLETED     2  
Withdrawal by Subject                 1  
Disease Progression                 1  



  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
Haploidentical NK Cells + Epratuzumab Haploidentical donor-derived NK cell infusion, Epratuzumab 360 mg/m^2 once a day by vein (IV) on Day -4, Day -1 and Days 3, 6, 10, 13 and 17, and low-dose interleukin-2 (IL-2) Subcutaneous injections three times a week for 9 doses on Days 0 to 21; Fludarabine 25 mg/m^2 once a day IV on Day -6 through Day -2 over 30 minutes; Cyclophosphamide 60 mg/kg once a day IV on Days -5 and -4 over 2 hours.

Baseline Measures
    Haploidentical NK Cells + Epratuzumab  
Number of Participants  
[units: participants]
  2  
Age  
[units: years]
Mean ( Full Range )
  11  
  ( 6 to 16 )  
Gender  
[units: participants]
 
Female     1  
Male     1  
Region of Enrollment  
[units: participants]
 
United States     2  



  Outcome Measures

1.  Primary:   Time to Progression (TTP)   [ Time Frame: 1 Year ]

2.  Secondary:   Overall Survival (OS)   [ Time Frame: Minimum of 1 year, or until disease progression or death ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  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: Anna Franklin, MD, Assistant Professor
Organization: University of Texas MD Anderson Cancer Center
phone: 713-792-3497
e-mail: rnjackso@mdanderson.org


No publications provided


Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00941928     History of Changes
Other Study ID Numbers: 2007-0160
Study First Received: July 16, 2009
Results First Received: May 22, 2013
Last Updated: May 19, 2014
Health Authority: United States: Food and Drug Administration