NK DLI in Patients After Human Leukocyte Antigen (HLA)-Haploidentical Hematopoietic Stem Cell Transplantation (HSCT)
|ClinicalTrials.gov Identifier: NCT01386619|
Recruitment Status : Completed
First Posted : July 1, 2011
Last Update Posted : September 15, 2015
This is a phase I/II study of highly selected donor lymphocyte infusions in patients undergoing HLA-haploidentical hemopoietic stem cell transplantation. Patients will be offered "pre-emptive" NK-DLI early after HSCT.
Three schedules of NK-cell infusion will be studied: Basel patients (adult and pediatric) will receive NK-DLI on days +40 and +100 (pre-emptive-late); Frankfurt patients (pediatric) will receive NK-DLI on days +3, +40, and +100 (pre-emptive early). Patients not receiving pre-emptive NK-DLI with loss in donor chimerism or with evidence of minimal residual disease will be offered "therapeutic" NK-DLI.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia, Myeloid, Acute Precursor Cell Lymphoblastic Leukemia-Lymphoma Myelodysplastic Syndromes Lymphoma Neuroblastoma Rhabdomyosarcoma||Biological: CD3-depleted/CD56+ selected natural killer cells collected from apheresis products||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Natural Killer Cell Selected T-cell Depleted Donor Lymphocyte Infusions (NK-DLI) in Patients After HLA-haploidentical Allogeneic Stem Cell Transplantation|
|Study Start Date :||January 2004|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||March 2011|
|Experimental: NK cell DLI||
Biological: CD3-depleted/CD56+ selected natural killer cells collected from apheresis products
NK DLI products containing >1 10e7 NK cells/kg bodyweight (BW) and < 1 x 10e5 T-cells/kg BW are administered at days +4 (Frankfurt only), and on days +40 and +100 (both centers)
- Feasibility of NK-DLI production [ Time Frame: At day of transplant (day 0) ]The feasibility of the production of expanded NK-cell DLI will be measured. Primary quality measures of the NK cell product are the number of NK cells that can be produced (CD56+/cluster of differentiation 3(CD3)- NK cell goal dose >= 1 * 10e7/kg body weight of recipient) as well as the degree of CD3 T-cell contamination (goal CD3+ T-cell dose < 1 * 10e5 / kg body weight of recipient).
- Safety of NK DLI Infusion [ Time Frame: Day +60 after transplant ]The safety evaluation regards transfusion associated adverse events (fever, fall in blood pressure, transfusion site reactions, etc) and is evaluated at the time of NK DLI infusion. The primary long-term safety measure is the absence of acute graft-versus-host disease 30 days after the last NK DLI infusion.
- Efficacy of NK DLI Infusions [ Time Frame: 5 years after last NK DLI ]The efficacy of NK DLI infusions will be assessed by evaluation of the rates of overall and disease free survival and the rate of disease relapse. As this is a single arm study, outcome measures assessed will be compared to those of historical controls treated with haploidentical HSCT without NK DLI infusions.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01386619
|Study Chair:||Jakob Passweg, MD||University Hospital, Basel, Switzerland|
|Study Chair:||Dirk Schwabe, MD||Universitätsklinikum Frankfurt|