Safety Trial of NK DLI From 6/6 HLA Matched Family Member Following Nonmyeloablative ASCT

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
David Rizzieri, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT00586690
First received: December 21, 2007
Last updated: November 26, 2012
Last verified: November 2012

December 21, 2007
November 26, 2012
May 2005
May 2013   (final data collection date for primary outcome measure)
Evaluate the safety of NK cell infusion using CD56 monoclonal antibody following nonmyeloablative stem cell transplantation from matched donors: toxicity including mortality, occurrence of acute GVHD and other severe toxicity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00586690 on ClinicalTrials.gov Archive Site
  • Evaluate efficacy of NK cell infusions in terms of response, progression free, and overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Evaluate the recovery of immune function post engraftment with this regimen [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety Trial of NK DLI From 6/6 HLA Matched Family Member Following Nonmyeloablative ASCT
Safety Trial of NK Cell Donor Lymphocyte Infusions From 6/6 HLA Matched Family Member Following Nonmyeloablative Allogeneic Stem Cell Transplantation

Evaluate the safety of NK cell infusion using CD56 monoclonal antibody selected with Miltenyi Biotec system following nonmyeloablative stem cell transplantation from matched donors. This pilot study will evaluate toxicity including mortality, occurrence of acute graft versus host disease and other severe toxicity.

The use of non-selected donor lymphocyte infusions (DLIs) (to help early immune recovery and induce antitumor response) following nonmyeloablative allogeneic stem cell transplantation 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 feasibility and toxicity of donor natural killer (NK) cell selection and infusion following nonmyeloablative allogeneic stem cell transplantation from matched donors. Additionally, we will assess immune reconstitution/function post NK cell infusion and evaluate efficacy.

Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphoma
Device: NK Cell Infusion following SCT from matched 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.
Experimental: I
NK Cell infusion using CD56 monoclonal antibody following nonmyeloablative SCT from matched donors
Intervention: Device: NK Cell Infusion following SCT from matched donors
Rizzieri DA, Storms R, Chen DF, Long G, Yang Y, Nikcevich DA, Gasparetto C, Horwitz M, Chute J, Sullivan K, Hennig T, Misra D, Apple C, Baker M, Morris A, Green PG, Hasselblad V, Chao NJ. Natural killer cell-enriched donor lymphocyte infusions from A 3-6/6 HLA matched family member following nonmyeloablative allogeneic stem cell transplantation. Biol Blood Marrow Transplant. 2010 Aug;16(8):1107-14. doi: 10.1016/j.bbmt.2010.02.018. Epub 2010 Feb 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
32
May 2015
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with who have undergone a non-myeloablative allogeneic transplant, using a 6/6 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 mycophenylate 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00586690
Pro00005124
Yes
David Rizzieri, Duke University Medical Center
David Rizzieri
Not Provided
Principal Investigator: David Rizzieri, MD Duke University Health System
Duke University
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP