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Donor Natural Killer Cell Infusion, Rituximab, Aldesleukin, and Chemotherapy in Treating Patients With Relapsed Non-Hodgkin Lymphoma or Chronic Lymphocytic Leukemia

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ClinicalTrials.gov Identifier: NCT00625729
Recruitment Status : Terminated (No patients exhibited natural killer cell expansion (primary endpoint).)
First Posted : February 28, 2008
Results First Posted : July 30, 2010
Last Update Posted : December 28, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Leukemia
Lymphoma
Interventions Biological: aldesleukin
Biological: allogeneic natural killer cells
Biological: rituximab
Drug: cyclophosphamide
Drug: fludarabine phosphate
Enrollment 6
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Patients Treated With Natural Killer Cells
Hide Arm/Group Description Patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with 1 dose donor natural killer cells infusion, 4 doses rituximab, 6 doses aldesleukin and 5 doses fludarabine and 1 dose cyclosphosphamide.
Period Title: Overall Study
Started 6
Completed 6
Not Completed 0
Arm/Group Title Patients Treated With Natural Killer Cells
Hide Arm/Group Description Patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with 1 dose donor natural killer cells infusion, 4 doses rituximab, 6 doses aldesleukin and 5 doses fludarabine and 1 dose cyclosphosphamide.
Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
<=18 years
0
   0.0%
Between 18 and 65 years
5
  83.3%
>=65 years
1
  16.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants
52.2  (13.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
4
  66.7%
Male
2
  33.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants
6
1.Primary Outcome
Title Number of Patients Exhibiting Natural Killer Cell Expansion
Hide Description Successful natural killer (NK) cell expansion will be defined as an absolute circulating donor-derived NK cell count of >100 cells/μl 14 days after infusion with <5% donor T and B cells in the mononuclear population.
Time Frame Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients Treated With Natural Killer Cells
Hide Arm/Group Description:
Patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with 1 dose donor natural killer cells infusion, 4 doses rituximab, 6 doses aldesleukin and 5 doses fludarabine and 1 dose cyclosphosphamide.
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: Participants
0
2.Secondary Outcome
Title Number of Patients With Interleukin-15 Production and NK Cell Expansion
Hide Description Correlation of interleukin-15 production at day 0 with natural killer (NK) cells expansion
Time Frame Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
Correlation of interleukin-15 with Natural Killer Cell expansion cannot be calculated because there was no Natural Killer Cell expansion.
Arm/Group Title Patients Treated With Natural Killer Cells
Hide Arm/Group Description:
Patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with 1 dose donor natural killer cells infusion, 4 doses rituximab, 6 doses aldesleukin and 5 doses fludarabine and 1 dose cyclosphosphamide.
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: Participants
0
3.Secondary Outcome
Title Number of Patients With Overall Response
Hide Description Overall response (complete remission plus partial remission) rate at 3 months, as defined by International Working Group for non-Hodgkin lymphoma and NCI Working Group guidelines for chronic lymphocytic leukemia
Time Frame 3 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients Treated With Natural Killer Cells
Hide Arm/Group Description:
Patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with 1 dose donor natural killer cells infusion, 4 doses rituximab, 6 doses aldesleukin and 5 doses fludarabine and 1 dose cyclosphosphamide.
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: Participants
4
4.Secondary Outcome
Title Number of Patients Whose Disease Progressed After Treatment
Hide Description Includes patients (with non-Hodgkin leukemia or chronic lymphocytic leukemia) whose disease progressed after treatment.
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients who responded to treatment included in the analysis.
Arm/Group Title Responder Patients
Hide Arm/Group Description:
Patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with donor natural killer cells infusion, rituximab, aldesleukin and chemotherapy who had a response to treatment (clinical response or partial response).
Overall Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: Participants
2
5.Secondary Outcome
Title Number of Patients With Adequate Natural Killer Cells Infused
Hide Description Incidence of donor products that met release criteria in accordance with FDA regulations (Lot Release Criteria for allogeneic, interleukin-2 (IL-2) activated natural killer (NK) cell products (BB-IND 8847) and the NK cell numbers infused (donor NK cell dose 1.5-8.0 x 10^7/kg).
Time Frame Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients Treated With Natural Killer Cells
Hide Arm/Group Description:
Patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with 1 dose donor natural killer cells infusion, 4 doses rituximab, 6 doses aldesleukin and 5 doses fludarabine and 1 dose cyclosphosphamide.
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: Participants
6
6.Secondary Outcome
Title Number of Patients With Overall Survival
Hide Description Number of patients alive at 6 months after treatment.
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients Treated With Natural Killer Cells
Hide Arm/Group Description:
Patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with 1 dose donor natural killer cells infusion, 4 doses rituximab, 6 doses aldesleukin and 5 doses fludarabine and 1 dose cyclosphosphamide.
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: Participants
3
Time Frame Serious adverse events were collected after start of chemotherapy treatment (Day -1) through date of death (all within 6 months).
Adverse Event Reporting Description

Stopping Rules for excess toxicity:

  • Any non-hematologic grade 4 toxicity except for fevers alone
  • Grade III/IV GvHD or GvHD requiring more than 7 days of therapy
  • Hematologic toxicity: prolonged neutropenia defined as an absolute neutrophil count of less than 500 on day +35. Prolonged anemia or thrombocytopenia will not constitute toxicity.
 
Arm/Group Title Patients Treated With Natural Killer Cells
Hide Arm/Group Description Patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with 1 dose donor natural killer cells infusion, 4 doses rituximab, 6 doses aldesleukin and 5 doses fludarabine and 1 dose cyclosphosphamide.
All-Cause Mortality
Patients Treated With Natural Killer Cells
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Patients Treated With Natural Killer Cells
Affected / at Risk (%) # Events
Total   5/6 (83.33%)    
Blood and lymphatic system disorders   
Neutrophils/granulocytes (ANC/AGC) † 1 [1]  1/6 (16.67%)  1
Cardiac disorders   
Cardiac Arrhythmia † 1 [2]  1/6 (16.67%)  1
General disorders   
Death - Disease Progression NOS † 1  3/6 (50.00%)  3
Infections and infestations   
Infection † 1  2/6 (33.33%)  2
Respiratory, thoracic and mediastinal disorders   
Pulmonary - obstruction/stenosis of airway † 1  1/6 (16.67%)  1
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
ANC <500 at day +35
[2]
Ventricular arrhythmia - Bigeminy
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Patients Treated With Natural Killer Cells
Affected / at Risk (%) # Events
Total   0/6 (0.00%)    
Study was terminated early due to lack of NK expansion and failure to meet primary outcome.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Veronika Bachanova, M.D.
Organization: Masonic Cancer Center, University of Minnesota
Phone: 612-625-5469
EMail: bach0173@umn.edu
Layout table for additonal information
Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00625729    
Other Study ID Numbers: 2007LS064
MT2007-12 ( Other Identifier: Blood and Marrow Transplantation Program )
UMN-0707M13561 ( Other Identifier: IRB, University of Minnesota )
P01CA065493 ( U.S. NIH Grant/Contract )
First Submitted: February 26, 2008
First Posted: February 28, 2008
Results First Submitted: July 2, 2010
Results First Posted: July 30, 2010
Last Update Posted: December 28, 2017