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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Charite University, Berlin, Germany.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of Leipzig
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01220544
First received: October 13, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted

October 13, 2010
October 13, 2010
July 2001
October 2010   (final data collection date for primary outcome measure)
To evaluate feasibility and safety of alloreactive CD56+/CD3- donor NK cells after one haplotype mismatched transplantation [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
To evaluate feasibility and safety of cellular immunotherapy with purified alloreactive CD56+/CD3- donor NK cells after one haplotype mismatched hematopoietic stem cell transplantation in patients with high risk hematological malignancies who lack an HLA-identical donor.
Same as current
No Changes Posted
  • transplant related mortality [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The investigation of transplant related mortality (incidence of veno occlusive disease; incidence and type of infectious complications).
  • effectiveness [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To evaluate the effectiveness of the therapy (relapse rate; disease free survival; MRD monitoring).
  • technical aspects of the cell separation procedure [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    To investigate technical aspects of the cell separation procedure (problems of stem cell mobilization; yield, viability, sterility and purity of the CD34+ and CD56+CD3- cell fraction; log CD3 depletion; in vitro anti-leukemic activity of the CD56+CD3- cell fraction).
  • stable engraftment of haploidentical stem cell grafts can be achieved after conditioning with total body irradiation, thiotepa, fludarabine and OKT3 and subsequent transfer of megadoses of positively selected CD34+ stem cells and CD56+CD3- NK-cells. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Graft rejection is defined as neutrophils < 0.5 x 10e9/l on day+28 post transplantation.
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Acute Myeloid Leukemias
  • Advanced Hematological Malignancies
  • Indication for Allogeneic Stem Cell Transplantation
  • no HLA-identical Donor Available
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.
Experimental: HaploTransplant with NK cells
Haploidentical transplantation of mega-dose CD34+ hematopoetic stem cells with transfer of CD56+CD3-NK cells at day +2
Intervention: Biological: Haploidentical transplantation with donor NK cells
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
October 2011
October 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 54 Years
No
Contact: Lutz Uharek, MD +49308445 ext 4550 lutz.uharek@charite.de
Contact: Birte Friedrichs, MD +49308445 ext 4574 birte.friedrichs@charite.de
Germany
 
NCT01220544
BELEHAPLO-1412001
Yes
Prof. Dr. Lutz Uharek, Charite University Medicine
Charite University, Berlin, Germany
University of Leipzig
Principal Investigator: Lutz Uharel, MD Charite University Medicine
Principal Investigator: Dietger Niederwieser, MD University of Leipzig
Charite University, Berlin, Germany
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP