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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2015-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Leukemia Solid Tumors

Keywords

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Recurrent or Refractory Leukemia or Solid Tumors in Pediatrics

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Clinimacs Cell Separation System

Intervention Type DEVICE

Depletion of T-cells

conditioning chemotherapy

Intervention Type DRUG

Methylprednisolone, Equine ATG, Cyclosporine, Fludarabine, Melphalan, Thiotepa and Rituximab.

DLI

Intervention Type OTHER

NK Cell selected DLI

Interventions

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Clinimacs Cell Separation System

Depletion of T-cells

Intervention Type DEVICE

conditioning chemotherapy

Methylprednisolone, Equine ATG, Cyclosporine, Fludarabine, Melphalan, Thiotepa and Rituximab.

Intervention Type DRUG

DLI

NK Cell selected DLI

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

6 Months

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kenneth DeSantes, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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Kenneth DeSantes., MD

Madison, Wisconsin, United States

Site Status

Countries

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United States