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

Charité University Medicine Berlin

Status and phase: Unknown; Phase 2; Phase 1

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

Treatments: Biological: Haploidentical transplantation with donor NK cells

Study type: Interventional

Funder types: Other

Identifiers

NCT01220544

BELEHAPLO-1412001

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 54 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with AML or ALL in first CR with the following high risk features:

  1. AML with aberration Del (5q) -5, del (7q) -7, t(9;22) or t(6;9), abn 3q, 9q, 11q, 20q, 21q, 17p;
  2. AML with a complex caryotype;
  3. secondary AML after previous chemo- or radiotherapy or MDS;
  4. Ph-positive ALL

• Patients with AML or ALL after induction failure or in second CR

• Patients with CML in second chronic or accelerated phase

• Patients with malignant Lymphoma and the following high risk features:

  1. relapse after autologous transplantation
  2. primary chemotherapy refractory disease

• All patients must fulfill the following criteria:

  1. lack of a suitable HLA-identical family, unrelated or cord blood donor
  2. no active infection, no severe impairment of cardial, pulmonary, renal and hepatic function
  3. blast count in the marrow < 30%
  4. informed consent

Exclusion criteria

• active infection, no severe impairment of cardial, pulmonary, renal and hepatic function
• blast count in the marrow > 30%
• unable or unwilling to sign and/or understand informed consent

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

HaploTransplant with NK cells

Experimental group

Description:

Haploidentical transplantation of mega-dose CD34+ hematopoetic stem cells with transfer of CD56+CD3-NK cells at day +2

Treatment:

Biological: Haploidentical transplantation with donor NK cells