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Safety Trial of NK Cell DLI 3-5/6 Family Member Following Nonmyeloablative ASCT

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ClinicalTrials.gov Identifier: NCT00586703
Recruitment Status : Completed
First Posted : January 4, 2008
Results First Posted : March 27, 2014
Last Update Posted : June 12, 2014
Sponsor:
Information provided by (Responsible Party):
David Rizzieri, MD, Duke University

Brief Summary:
Evaluate the safety of natural killer (NK) cell infusion using CD56 monoclonal antibody selected with Miltenyi Biotec system following nonmyeloablative stem cell transplantation (SCT) from mismatched donors. This pilot study will evaluate toxicity including mortality, occurrence of acute graft versus host disease (aGVHD) and other severe toxicity.

Condition or disease Intervention/treatment Phase
Lymphoma Device: NK-CD56 Phase 1

Detailed Description:

The use of non-selected donor lymphocyte infusions (DLIs) (to help early immune recovery and induce antitumor response) following nonmyeloablative allogeneic stem cell transplantation (ASCT) is also complicated by the risk of acute graft versus host disease (aGVHD) with 30-40% of patients experiencing grade III-IV aGVHD. Data suggests that the use of natural killer (NK) cells (instead of nonselected DLIs) in this setting may mediate a graft versus tumor (GVT) effect independently of aGVHD.

This pilot study is designed to evaluate the efficacy and toxicity of donor natural killer (NK) cell selection and infusion following nonmyeloablative allogeneic stem cell transplantation from mismatched donors.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety Trial of Natural Killer (NK) Cell Donor Lymphocyte Infusions (DLI) From 3-5/6 Human Leukocyte Antigen (HLA) Matched Family Member Following Nonmyeloablative Allogeneic Stem Cell Transplantation (ASCT)
Study Start Date : April 2005
Actual Primary Completion Date : April 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NK-CD56
NK Cell infusion using CD56 monoclonal antibody following nonmyeloablative SCT from mismatched donors
Device: NK-CD56
NK Cell infusion using CD56 monoclonal antibody following nonmyeloablative SCT from mismatched donors: The cells from leukapheresis will be NK selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II aGVHD at the time of infusion. Patients will be evaluated for toxicity and response until 20 weeks after the last NK Infusion.




Primary Outcome Measures :
  1. Toxicity [ Time Frame: 8 weeks ]
    Evaluate the safety of NK cell infusion using CD56 monoclonal antibody following nonmyeloablative stem cell transplantation from mismatched donors: Toxicity including mortality, occurrence of acute graft versus host disease (aGVHD) and other severe toxicity.


Secondary Outcome Measures :
  1. Efficacy - Overall Survival [ Time Frame: 7 years ]
    Evaluate the efficacy of the regimen in terms of overall survival (OS).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with who have undergone a non-myeloablative allogeneic transplant, using a 3-5/6 HLA matched sibling donor. Measureable disease is not needed at study entry.
  • Performance status must be Karnofsky 50-100%.
  • Donor cellular engraftment of at least 2.5% from the non-myeloablative procedure.
  • ≤ Grade 2 acute GVHD at time of infusion of NK cell infusion. Patients with treated acute GVHD must be on a stable dose of therapy (no increase in immunosuppressive therapy for the 2 weeks before planned NKI). The dosage/level of immunosuppressive therapy at the time of NKI should be no greater than 1 mg/kg of prednisone daily or mycophenolate 1000 mg bid daily or cyclosporine with a target level of 200 or equivalent.
  • Estimated survival at least 8 weeks.
  • Age > or equal to 18 years of age.

Exclusion Criteria:

  • Pregnant or lactating women,
  • Patients with other major medical or psychiatric illnesses, which the treating physician feels, could seriously compromise tolerance to this protocol.
  • Patients who had biopsy proven overall Grade 4 GVHD lasting longer than 7 days, from the non-myeloablative therapy, are not eligible

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00586703


Locations
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United States, North Carolina
Duke University Health Systems
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
David Rizzieri, MD
Investigators
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Principal Investigator: David Rizzieri, MD Duke University Health Systems
Publications of Results:
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Responsible Party: David Rizzieri, MD, Associate Professor of Medicine, Duke University
ClinicalTrials.gov Identifier: NCT00586703    
Other Study ID Numbers: Pro00005123
First Posted: January 4, 2008    Key Record Dates
Results First Posted: March 27, 2014
Last Update Posted: June 12, 2014
Last Verified: May 2014
Keywords provided by David Rizzieri, MD, Duke University:
Stem cell transplant
mismatched donor
NK infusion