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

Phase 1

Completed

• Conditions: Lymphoma
• Interventions: Device: NK-CD56

• Registration Number: NCT00586703
• Lead Sponsor: David Rizzieri, MD

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.

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.

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2007-12-21
• Study First Posted: 2008-01-04
• Primary Completion: 2013-04
• Study Completion: 2013-11
• Results First Submitted: 2014-02-05
• Results First Submitted QC: 2014-02-05
• Results First Posted: 2014-03-27
• Status Verified: 2014-05
• Last Update Submitted: 2014-06-06
• Last Update Posted: 2014-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NK-CD56	NK-CD56	NK Cell infusion using CD56 monoclonal antibody following nonmyeloablative SCT from mismatched donors

Primary Outcome Measures

Name	Time	Method
Toxicity	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

Name	Time	Method
Efficacy - Overall Survival	7 years	Evaluate the efficacy of the regimen in terms of overall survival (OS).

Trial Locations

Locations (1)

Duke University Health Systems; 🇺🇸 Durham, North Carolina, United States