Haploidentical NK-cell Infusion in Acute Myeloid Leukemia

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Leukemia cells can be killed by natural killer (NK) from HLA-I mismatched donor. The proposed study plans to realize an adoptive anti-leukaemic immunotherapy by infusion of HLA-I mismatched NK cells to treat poor prognosis acute myeloid leukemia patients. NK cells will be selected from HLA mismatch familial donor peripheral mononuclear cells by purification protocol. Before NK-infusion, patients received immunosuppressive chemotherapy.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Criteria

1. Recipient selection

1. Patient eligibility

• Poor prognosis de novo AML including :

1. Primary refractory disease (absence of complete remission (CR) after at least 2 different induction regimens)

2. Relapsed disease that did not reach CR after at least 1 salvage therapy

3. First untreated early relapse (less than one year of remission duration) in the absence of allogeneic HSCT project.

• Age between 18 and 65

• No liver and renal dysfunctions contraindicating the administration of Fludarabine, Cyclophosphamide or Cytarabine.

• Written informed consent

2. Patient exclusion criteria

• Secondary AML.

• Previous autologous or allogeneic transplantation. Since the main objective of the study concerns the hematological toxicity, we decided to exclude patients with secondary AML or who had been previously transplanted because of their expected higher hematological toxicity.

• Patient with allogeneic transplant project

• HIV positive serology

2. Donor eligibility

• HLA haploidentical brother, sister, child (older than 18 years), father, sister, cousin, uncle, aunt.

• Donor with KIR ligand mismatch in the GvL direction

• Absence of contraindication for leukapheresis.

• Negative HIV1-2, HTLV-1-2, HBV, and HCV serology. Negative viral genomic screening for HTLV1-2 and HCV

• Written informed consent