Haploidentical Transplantation With Early Adoptive Transfer of CD56+CD3- NK Cells
|ClinicalTrials.gov Identifier: NCT01220544|
Recruitment Status : Unknown
Verified October 2010 by Charite University, Berlin, Germany.
Recruitment status was: Recruiting
First Posted : October 14, 2010
Last Update Posted : October 14, 2010
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemias Advanced Hematological Malignancies Indication for Allogeneic Stem Cell Transplantation no HLA-identical Donor Available||Biological: Haploidentical transplantation with donor NK cells||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Transplantation of Hematopoetic Stem Cells and Infusion of CD56+CD3- NK Cells From Haploidentical Donors for Patients With Hematological Malignancies|
|Study Start Date :||July 2001|
|Estimated Primary Completion Date :||October 2010|
|Estimated Study Completion Date :||October 2011|
Experimental: HaploTransplant with NK cells
Haploidentical transplantation of mega-dose CD34+ hematopoetic stem cells with transfer of CD56+CD3-NK cells at day +2
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.
- To evaluate feasibility and safety of alloreactive CD56+/CD3- donor NK cells after one haplotype mismatched transplantation [ Time Frame: 1 year ]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.
- transplant related mortality [ Time Frame: 1 year ]The investigation of transplant related mortality (incidence of veno occlusive disease; incidence and type of infectious complications).
- effectiveness [ Time Frame: 2 years ]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 ]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 ]Graft rejection is defined as neutrophils < 0.5 x 10e9/l on day+28 post transplantation.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01220544
|Contact: Lutz Uharek, MD||+49308445 ext email@example.com|
|Contact: Birte Friedrichs, MD||+49308445 ext firstname.lastname@example.org|
|Charite Campus Benjamin FRanklin, Medical Clinic III, Department of Hematology/Oncology||Recruiting|
|Berlin, Germany, 12200|
|Contact: Lutz Uharek, Prof. +49308445 ext 4550 email@example.com|
|Contact: Birte Friedrichs, Dr. +49308445 ext 4574 firstname.lastname@example.org|
|Medical Clinic II, Department of Hematology/Oncology, University of Leipzig||Recruiting|
|Leipzig, Germany, 04103|
|Contact: Dietger Niederwieser, Prof. +4934197 ext 13050 email@example.com|
|Contact: Nadezda Basara, Dr. Nadezda.Basara@medizin.uni-leipzig.de|
|Principal Investigator:||Lutz Uharel, MD||Charite University Medicine|
|Principal Investigator:||Dietger Niederwieser, MD||University of Leipzig|