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

This study has been terminated.

( No patients exhibited natural killer cell expansion (primary endpoint). )

Study NCT00625729 Information provided by Masonic Cancer Center, University of Minnesota

First Received on February 26, 2008. Last Updated on September 22, 2010 History of Changes

Results First Received: July 2, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Leukemia Lymphoma
Interventions:	Biological: aldesleukin Biological: allogeneic natural killer cells Biological: rituximab Drug: cyclophosphamide Drug: fludarabine phosphate

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
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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 Treated With Natural Killer Cells	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.

Participant Flow: Overall Study

	Patients Treated With Natural Killer Cells
STARTED	6
COMPLETED	6
NOT COMPLETED	0

Baseline Characteristics

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Reporting Groups

	Description
Patients Treated With Natural Killer Cells	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.

Baseline Measures

	Patients Treated With Natural Killer Cells
Number of Participants [units: participants]	6
Age [units: participants]
<=18 years	0
Between 18 and 65 years	5
>=65 years	1
Age [units: years] Mean ± Standard Deviation	52.2 ± 13.6
Gender [units: participants]
Female	4
Male	2
Region of Enrollment [units: participants]
United States	6

Outcome Measures

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1. Primary:

Number of Patients Exhibiting Natural Killer Cell Expansion [ Time Frame: Day 14 ]

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2. Secondary:

Number of Patients With Interleukin-15 Production and NK Cell Expansion [ Time Frame: Day 0 ]

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3. Secondary:

Number of Patients With Overall Response [ Time Frame: 3 Months ]

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4. Secondary:

Number of Patients Whose Disease Progressed After Treatment [ Time Frame: 6 Months ]

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5. Secondary:

Number of Patients With Adequate Natural Killer Cells Infused [ Time Frame: Day 0 ]

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6. Secondary:

Number of Patients With Overall Survival [ Time Frame: 6 Months ]

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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
Study was terminated early due to lack of NK expansion and failure to meet primary outcome.

Results Point of Contact:

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

No publications provided

Responsible Party:	Veronika Bachanova, MD, Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:	NCT00625729 History of Changes
Other Study ID Numbers:	2007LS064, MT2007-12, UMN-0707M13561, P01CA065493
Study First Received:	February 26, 2008
Results First Received:	July 2, 2010
Last Updated:	September 22, 2010
Health Authority:	United States: Food and Drug Administration