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Haploidentical Transplant With NK Cell Infusion for Pediatric Acute Leukemia and Solid Tumors

This study has been terminated.
Miltenyi Biotec GmbH
Information provided by (Responsible Party):
University of Wisconsin, Madison Identifier:
First received: December 19, 2007
Last updated: April 20, 2016
Last verified: April 2016

December 19, 2007
April 20, 2016
August 2008
August 2015   (Final data collection date for primary outcome measure)
Grade III or IV GVHD [ Time Frame: Day 100 ]
Same as current
Complete list of historical versions of study NCT00582816 on Archive Site
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Haploidentical Transplant With NK Cell Infusion for Pediatric Acute Leukemia and Solid Tumors
Reduced Intensity Haploidentical Transplantation With NK Cell Infusion for Pediatric Acute Leukemia and High Risk Solid Tumors, BMT06407
This study will assess the feasibility of utilizing a reduced intensity conditioning regimen, in the setting of haploidentical transplantation, for patients with recurrent acute lymphoblastic leukemia (ALL), AML and high risk or refractory solid tumors. In addition, the feasibility and safety of administering post-transplant NK cell infusions will be evaluated. Data obtained from this study will help determine the efficacy of allogeneic HSCT in the treatment of pediatric sarcomas and add to the small body of literature utilizing haploidentical HSCT to treat acute leukemia in pediatric patients. This study will also further elucidate the role of NK cells in mediating a graft vs. tumor effect in allogeneic HSCT. The main benefit to society is that this study will explore a novel therapy for children with highly refractory cancer who are felt to be incurable with conventional approaches. If feasibility is demonstrated, and there is evidence of anti-tumor activity, then this will open up a new area of clinical research to better define the efficacy of this approach for specific childhood malignancies.
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Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Leukemia
  • Solid Tumors
  • Device: Clinimacs Cell Separation System
    Depletion of T-cells
  • Drug: conditioning chemotherapy
    Methylprednisolone, Equine ATG, Cyclosporine, Fludarabine, Melphalan, Thiotepa and Rituximab.
  • Other: DLI
    NK Cell selected DLI
Experimental: 1
patients will undergo a standard pre-transplant evaluation, but will also have blood drawn to evaluate their HLA class I killer immunoglobulin-like receptor (KIR) ligand typing. Parents will undergo KIR genotyping and phenotyping, and a donor will be selected based on which parent shows the greatest degree of KIR receptor-ligand mismatching. Once the donor has been selected he/she will undergo a peripheral blood stem cell (PBSC) collection utilizing G-CSF and GM-CSF for stem cell mobilization. The PBSC collection will be performed utilizing standard procedures. The PBSC will then be processed in the UW BMT Laboratory in order to deplete the graft of T cells. This will be accomplished using the CliniMACS cell separation system. T cell depletion is a standard procedure for patients receiving haploidentical stem cell grafts. The resulting stem cell product will be analyzed for T cell, stem cell and NK cell content.
  • Device: Clinimacs Cell Separation System
  • Drug: conditioning chemotherapy
  • Other: DLI
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
August 2015
August 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Solid tumors that have failed auto transplant or are ineligible to receive auto transplant
  • Relapsed AML in 1st relapse or 2nd or 3rd CR
  • Relapsed ALL if they fail to attain an initial remission or if they relapse within 1 year following the discontinuation of chemotherapy.
  • Greater than or equal to 6 months and <26 years old
  • Suitable haploidentical donor available

Exclusion Criteria:

  • Leukemia with >25% blasts in bone marrow at the time of admission to the HSCT unit.
  • Serum bilirubin >3 mg/dl
  • GFR <40 ml/min/1.73 mw
  • Cardiac left ventricular ejection fraction <40%
  • HIV+
  • Pregnant
Sexes Eligible for Study: All
6 Months to 25 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
United States
H-2006-0297 ( Other Identifier: UW IRB )
2012-0661 ( Other Identifier: UW IRB )
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University of Wisconsin, Madison
University of Wisconsin, Madison
Miltenyi Biotec GmbH
Principal Investigator: Kenneth DeSantes, M.D. University of Wisconsin, Madison
University of Wisconsin, Madison
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP