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Natural Killer Cell Selected T-cell Depleted Donor Lymphocyte Infusions (NK-DLI) in Patients After HLA-haploidentical Allogeneic Stem Cell Transplantation


Phase 1/Phase 2
N/A
N/A
Open (Enrolling)
Both
Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Myelodysplastic Syndromes, Lymphoma, Neuroblastoma, Rhabdomyosarcoma

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Trial Information

Natural Killer Cell Selected T-cell Depleted Donor Lymphocyte Infusions (NK-DLI) in Patients After HLA-haploidentical Allogeneic Stem Cell Transplantation


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Feasibility of NK-DLI production

Outcome Description:

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).

Outcome Time Frame:

At day of transplant (day 0)

Safety Issue:

No

Principal Investigator

Jakob Passweg, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University Hospital, Basel, Switzerland

Authority:

Switzerland: Swissmedic

Study ID:

NK-DLI Allo-Tx

NCT ID:

NCT01386619

Start Date:

January 2004

Completion Date:

Related Keywords:

  • Leukemia, Myeloid, Acute
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Myelodysplastic Syndromes
  • Lymphoma
  • Neuroblastoma
  • Rhabdomyosarcoma
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Lymphoma
  • Myelodysplastic Syndromes
  • Preleukemia
  • Neuroblastoma
  • Rhabdomyosarcoma

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