NK Cell Based Non-Myeloablative Transplantation in Acute Myeloid Diseases

Acute Myeloid Leukemia Clinical Trial

Official title: Multi-Center Phase II Trial of NK Cell Based Non-Myeloablative Haploidentical Transplantation for Patients With High-Risk Acute Myeloid Diseases

Status Completed

Clinical Trial Summary

This is a phase II multi-institutional therapeutic study of NK-cell based nonmyeloablative haploidentical transplantation for the treatment of high-risk acute myeloid diseases. Enrollment will use a two-stage design. Stage 1 will enroll 15 patients unless an early stopping rule is met. If 9 or more of these first 15 patients achieve leukemia free neutrophil engraftment at day +28 accrual will move to stage 2. In stage 2, an additional 28 patients will be enrolled for a total of 43 patients. Patients will be followed for disease response for 2 years.

Clinical Trial Description

A reduced intensity conditioning using Fludara, Cytoxan, and irradiation will start on day -22, followed by infusion of donor NK (natural killer) cells on day-17, 6 doses of interleukin-2 (IL-2) to promote NK expansion (day -17 to day -7), 2 doses of ATG for additional immunosuppression to promote engraftment (day -5 to -4), and infusion of a TCR α/β-depleted same donor graft on day 0. ;

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes

• NCT number: NCT01370213
• Study type: Interventional
• Source: Masonic Cancer Center, University of Minnesota
• Status: Completed
• Phase: Phase 2
• Start date: September 2011
• Completion date: April 2017