NCT01220544

Haploidentical Transplantation With Early Adoptive Transfer of CD56+CD3- NK Cells

Transplantation of Hematopoetic Stem Cells and Infusion of CD56+CD3- NK Cells From Haploidentical Donors for Patients With Hematological Malignancies

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: All
• Age: 18 Years – 54 Years
• Healthy volunteers: Not accepted

Summary

Experimental and clinical data suggest that alloreactive NK cells can reduce the risk of graft-rejection, GvHD and leukemic relapse after HLA-mismatched transplantation. The effectiveness of allogeneic NK cells is a function of HLA-differences between donor and recipient that give rise to NK cell clones which do not express inhibitory receptors matching for the HLA molecules of the recipient. Aim of the study is to evaluate cellular therapy with alloreactive, IL-2 activated NK cells after transplantation of T-cell depleted stem cell grafts from one haplotype mismatched family donors in patients with hematological malignancies.

Conditions

• Acute Myeloid Leukemias
• Advanced Hematological Malignancies
• Indication for Allogeneic Stem Cell Transplantation
• no HLA-identical Donor Available

Interventions

Type	Name	Description
BIOLOGICAL	Haploidentical transplantation with donor NK cells	Pat received a myeloablative conditioning regimen with 12 Gy total-body irradiation in six single doses from day -11 to day -9, thiotepa (5mg/kg/d) on days -8 and -7, fludarabine (40mg/m2/d) from day -6 to day -3, and OKT-3 (5mg/d) from day -5 to day +3. The stem cell graft was aimed to contain \> 8 x 10e6 CD34+ cells/kg and \< 5 x 10e4 CD3+ cells/kg. A minimum of 1 x 10e7 CD56+CD3- NK cells/kg will be transferred on days +2.

Timeline

• Start date: 2001-07-01
• Primary completion: 2010-10-01
• Completion: 2011-10-01
• First posted: 2010-10-14
• Last updated: 2010-10-14

Locations

2 sites across 1 country: Germany