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Safety Trial of NK Cell Donor Lymphocyte Infusions From 3-5/6 HLA Matched Family Member Following Nonmyeloablative Allogeneic Stem Cell Transplantation


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

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Trial Information

Safety Trial of NK Cell Donor Lymphocyte Infusions From 3-5/6 HLA Matched Family Member Following Nonmyeloablative Allogeneic Stem Cell Transplantation


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 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 mismatched donors. Additionally, we will assess immune
reconstitution/function post NK cell infusion and evaluate efficacy.


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
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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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 GVHD and other severe toxicity.

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

David Rizzieri, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University Health Systems

Authority:

United States: Food and Drug Administration

Study ID:

Pro00005123

NCT ID:

NCT00586703

Start Date:

April 2005

Completion Date:

April 2015

Related Keywords:

  • Lymphoma
  • Stem cell transplant
  • mismatched donor
  • NK infusion
  • Lymphoma

Name

Location
Duke University Health Systems Durham, North Carolina  27710