NK DLI in Patients After HLA-haploidentical HSCT

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
First received: June 7, 2011
Last updated: September 19, 2014
Last verified: September 2014

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 Intervention Phase
Leukemia, Myeloid, Acute
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Myelodysplastic Syndromes
Biological: CD3-depleted/CD56+ selected natural killer cells collected from apheresis products
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Feasibility of NK-DLI production [ Time Frame: At day of transplant (day 0) ] [ Designated as safety issue: No ]
    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+/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 ] [ Designated as safety issue: Yes ]
    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:
  • Efficacy of NK DLI Infusions [ Time Frame: 5 years after last NK DLI ] [ Designated as safety issue: No ]
    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.

Estimated Enrollment: 15
Study Start Date: January 2004
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 BW and < 1 x 10e5 T-cells/kg BW are administered at days +4 (Frankfurt only), and on days +40 and +100 (both centers)


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 GvHD
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01386619

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

No publications provided

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01386619     History of Changes
Other Study ID Numbers: NK-DLI Allo-Tx
Study First Received: June 7, 2011
Last Updated: September 19, 2014
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Bone Marrow Diseases
Hematologic Diseases
Immune System Diseases
Immunoproliferative Disorders
Leukemia, Lymphoid
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on March 26, 2015