Safety Trial of NK Cell DLI 3-5/6 Family Member Following Nonmyeloablative ASCT
Completed · Phase 1
Conditions studied: Lymphoma
In brief
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.
Key facts
- Study ID
- NCT00586703
- Run by
- David Rizzieri, MD
- People needed
- 21
- Starts
- 2005-04-01
- Expected to finish
- 2013-11-01
- Last updated by the study team
- 2014-06-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Duke University Health Systems — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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