A Phase I Trial of Alloreactive Cell Infusion Following Transplantation of Haplotype Cells in Patients With Myeloid Malignancies

A PHASE I TRIAL OF ALLOREACTIVE NK CELLS INFUSION FOLLOWING TRANSPLANTATION OF HAPLOTYPE MISMATCHED, KIR MISMATCHED HIGHLY PURIFIED CD34 CELLS IN PATIENTS WITH ADVANCED OR REFRACTORY MYELOID MALIGNANCIES

The purpose of this study is to determine the maximum tolerated dose of alloreactive NK cells that can be transfused following stem cell transplant.

Inclusion Criteria:

• Patients must have histologically documented AML, ALL, MDS, CML,
• Identification of haploidentical donor
• LVEF > 45% corrected
• DLCO > 50% predicted
• Serum Creatinine <= 2 mg/dL
• Bilirubin < 2 x ULN
• AST, ALT < 2 x ULN
• Age ≤ 65 years
• Performance Status 0-1

Exclusion Criteria:

• Patients relapsing <6 months after autologous SCT are not eligible.
• Patients with active infections requiring oral or intravenous antibiotics are not eligible for enrollment until resolution of infection
• No HIV disease
• Non-pregnant and non-nursing