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

This study has suspended participant recruitment.
(Data analysis after engraftment failure)
Sponsor:
Collaborator:
Miltenyi Biotec GmbH
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00582816
First received: December 19, 2007
Last updated: March 7, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Leukemia
Solid Tumors
Device: Clinimacs Cell Separation System
Drug: conditioning chemotherapy
Other: DLI
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Reduced Intensity Haploidentical Transplantation With NK Cell Infusion for Pediatric Acute Leukemia and High Risk Solid Tumors, BMT06407

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Grade III or IV GVHD [ Time Frame: Day 100 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 12
Study Start Date: August 2008
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Depletion of T-cells
Drug: conditioning chemotherapy
Methylprednisolone, Equine ATG, Cyclosporine, Fludarabine, Melphalan, Thiotepa and Rituximab.
Other: DLI
NK Cell selected DLI

  Eligibility

Ages Eligible for Study:   6 Months to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00582816

Locations
United States, Wisconsin
Kenneth DeSantes., MD
Madison, Wisconsin, United States, 53972
Sponsors and Collaborators
University of Wisconsin, Madison
Miltenyi Biotec GmbH
Investigators
Principal Investigator: Kenneth DeSantes, M.D. University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00582816     History of Changes
Other Study ID Numbers: BMT06407, H-2006-0297, 2012-0661
Study First Received: December 19, 2007
Last Updated: March 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Wisconsin, Madison:
Recurrent or Refractory Leukemia or Solid Tumors in Pediatrics

Additional relevant MeSH terms:
Leukemia
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on August 26, 2014