Haploidentical Transplantation With Early Adoptive Transfer of CD56+CD3- NK Cells
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|