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NK DLI in Patients After Human Leukocyte Antigen (HLA)-Haploidentical Hematopoietic Stem Cell Transplantation (HSCT)

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ClinicalTrials.gov Identifier: NCT01386619
Recruitment Status : Completed
First Posted : July 1, 2011
Last Update Posted : September 15, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief Summary:

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)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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)



Primary Outcome Measures :
  1. 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).

  2. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with acute/chronic leukemia, myelodysplastic syndrome, lymphoid neoplasia, solid tumor or bone marrow failure syndrome
  • signed informed consent of the patient (or his/her legal representative)

Exclusion Criteria:

  • Patients with graft failure
  • Patients with any grade of active acute of chronic graft-versus-host disease (GvHD)

Information from the National Library of Medicine

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): NCT01386619


Locations
Germany
Universitätsklinikum
Frankfurt, Germany
Switzerland
University Hospital
Basel, Switzerland
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Study Chair: Jakob Passweg, MD University Hospital, Basel, Switzerland
Study Chair: Dirk Schwabe, MD Universitätsklinikum Frankfurt

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01386619     History of Changes
Other Study ID Numbers: NK-DLI Allo-Tx
First Posted: July 1, 2011    Key Record Dates
Last Update Posted: September 15, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Lymphoma
Leukemia
Myelodysplastic Syndromes
Preleukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neuroblastoma
Rhabdomyosarcoma
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Myosarcoma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Sarcoma