NCT00460629

Prophylactic Transfer of Leukemia-reactive T Cells After Allogeneic Transplantation

Specific Cellular Immunotherapy in Patients With Chronic Myeloid Leukemia After Allogeneic Stem Cell Transplantation

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University Hospital Carl Gustav Carus · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Efforts to decrease the risk of GvHD by depleting T cells from the graft in CML patients have been complicated by an increased incidence of leukemia-relapse. Newer protocols using CD34+ selected hematopoietic cells from matched-sibling donors and subsequent infusion of T cells in incremental doses to treat or avoid relapse of disease seem to be more promising. In this study, we try to further optimize this approach by the prophylactic infusion of cytotoxic T cells activated ex-vivo against leukemia-associated/specific antigens using peptide-pulsed dendritic cells.

Detailed description

The conditioning protocol contains: Total Body Irradiation 8-12 Gy (4-6 x 2 Gy, a 2 x/die) day -9 to-7 Thiotepa 10 mg/kg (2 x 5 mg/kg) day -5 Fludarabine 200 mg/m2 (5 x 40 mg/m2) day -6 to-2 ATG Fresenius 25 mg/kg (5 x 5 mg/kg) day -6 to-2 Cyclosporine A 1 mg/kg Day -10 to-3 on day 0 CD34+ cells after immunomagnetic selection are infused. \> 4 x 10e6/kg CD34 cells/kg are required. On days 28, 56 and 112 after transplantation, cytotoxic T cells generated in-vitro are infused in patients who do not have signs of acute GvHD. Regular follow-up compromises immune monitoring including Tetramer analyses of Peptide-reactive T cells

Conditions

• Chronic Myeloid Leukemia

Interventions

Type	Name	Description
PROCEDURE	Application of activated donor T cells	Ex-vivo generated donor T cells stimulated by antigen presenting cells loaded with peptides derived from leukemia-associated antigens

Timeline

• Start date: 2005-03-01
• Primary completion: 2011-12-01
• First posted: 2007-04-16
• Last updated: 2013-06-20

Locations

1 site across 1 country: Germany