Phase 1
Completed N=43
Safety Trial of NK DLI From 6/6 HLA Matched Family Member Following Nonmyeloablative ASCT
Source: ClinicalTrials.gov NCT00586690 ↗Enrolled (actual)
43
Serious AEs
19.1%
Results posted
Jun 2014
Primary outcomePrimary: Toxicity — 1; 8 participants
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 matched donors. This pilot study will evaluate toxicity including mortality, occurrence of acute graft versus host disease and other severe toxicity.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Toxicity |
1; 8 | — |
| SECONDARY Efficacy - Progression Free Survival |
12 | — |
| SECONDARY Efficacy - Overall Survival |
31 | — |
| SECONDARY Efficacy - Disease Progression |
10 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with who have undergone a non-myeloablative allogeneic transplant, using a 6/6 human leukocyte antigen (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 Graft versus Host Disease (aGvHD) at time of infusion of natural killer (NK) cell infusion. Patients with treated aGVHD must be on a stable dose of therapy (no increase in immunosuppressive therapy for the 2 weeks before planned natural killer cell infusion [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
Data sourced from ClinicalTrials.gov (NCT00586690). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.