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Penostatin, Rituximab and Ontak and Allogeneic Natural Killer (NK) Cells for Refractory Lymphoid Malignancies

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT01181258
First received: August 12, 2010
Last updated: April 10, 2017
Last verified: January 2016
Results First Received: April 10, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Conditions: Non-Hodgkin Lymphoma
Chronic Lymphocytic Leukemia
Interventions: Drug: Rituximab
Biological: Interleukin-2
Biological: Natural killer cells
Drug: Cyclophosphamide
Drug: Methylprednisolone
Drug: Fludarabine

  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 Receiving NK Cell Infusion

Non-Myeloablative Conditioning Using Rituximab, Fludarabine, Cyclophosphamide and Methylprednisolone followed by Interleukin 2-activated Allogeneic Natural Killer Cells infusion for Patients with Refractory NHL and CLL

Rituximab: 375 mg/m^2 administered intravenously (IV) weekly * 4, (day -7, -1, +6, +13) pre-infusion with natural killer cells (NK)

Interleukin-2: subcutaneously administered 9 million international units (IU) every other day * 6 doses over 2 weeks begin 1 to 24 hours after NK cell infusion. If weight < 45 kilograms, give IL-2 at 5 million units/m2 on same schedule.

Natural killer cells: administered intravenously 1.5 to 8 * 10^7 cells/kg on Day 0 (day of NK cell infusion)

Cyclophosphamide: 60 mg/kg administered intravenously (IV) for 2 hours on day -5 after Fludarabine

Methylprednisolone: 1 mg/kg on Days -2 through +9 as an intravenous (IV) infusion

Fludarabine: 25 mg/m^2/day administered as a 1 hour IV infusion once a day for 5 doses (day -6 through


Participant Flow:   Overall Study
    Patients Receiving NK Cell Infusion
STARTED   16 
COMPLETED   16 
NOT COMPLETED   0 



  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
Patients Receiving NK Cell Infusion

Non-Myeloablative Conditioning Using Rituximab, Fludarabine, Cyclophosphamide and Methylprednisolone followed by Interleukin 2-activated Allogeneic Natural Killer Cells infusion for Patients with Refractory NHL and CLL

Rituximab: 375 mg/m^2 administered intravenously (IV) weekly * 4, (day -7, -1, +6, +13) pre-infusion with natural killer cells (NK)

Interleukin-2: subcutaneously administered 9 million international units (IU) every other day * 6 doses over 2 weeks begin 1 to 24 hours after NK cell infusion. If weight < 45 kilograms, give IL-2 at 5 million units/m2 on same schedule.

Natural killer cells: administered intravenously 1.5 to 8 * 10^7 cells/kg on Day 0 (day of NK cell infusion)

Cyclophosphamide: 60 mg/kg administered intravenously (IV) for 2 hours on day -5 after Fludarabine

Methylprednisolone: 1 mg/kg on Days -2 through +9 as an intravenous (IV) infusion

Fludarabine: 25 mg/m^2/day administered as a 1 hour IV infusion once a day for 5 doses (day -6 through


Baseline Measures
   Patients Receiving NK Cell Infusion 
Overall Participants Analyzed 
[Units: Participants]
 16 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      14  87.5% 
>=65 years      2  12.5% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      3  18.8% 
Male      13  81.3% 
Region of Enrollment 
[Units: Participants]
 
United States   16 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Objective Response Rate   [ Time Frame: Month 2 Post Infusion ]

2.  Secondary:   Serious Adverse Events   [ Time Frame: Day 1 through Month 12 ]

3.  Secondary:   Time to Disease Progression   [ Time Frame: Day 1 through Month 12 ]

4.  Secondary:   Patients With Expansion of NK Cells   [ Time Frame: Day 14 ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Veronika Bachanova
Organization: Masonic Cancer Center, University of Minnesota
phone: 612-625-5469
e-mail: bach0173@umn.edu



Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT01181258     History of Changes
Other Study ID Numbers: 2009LS083
MT2009-15 ( Other Identifier: Blood and Marrow Transplantation Program )
1002M77545 ( Other Identifier: IRB, University of Minnesota )
Study First Received: August 12, 2010
Results First Received: April 10, 2017
Last Updated: April 10, 2017