A Phase I Trial of Alloreactive Cell Infusion Following Transplantation of Haplotype Cells in Patients With Myeloid Malignancies

NCT ID: NCT00569179

Last Updated: 2015-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2010-12-31

Brief Summary

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The purpose of this study is to determine the maximum tolerated dose of alloreactive NK cells that can be transfused following stem cell transplant.

Detailed Description

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Conditions

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Leukemia, Myeloid, Acute Leukemia, Lymphoid Myelodysplastic Syndromes Leukemia, Myelogenous, Chronic

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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Alloreactive NK cell infusion

Escalating doses of alloreactive NK cells.

Group Type EXPERIMENTAL

CliniMACS CD34 Reagent System

Intervention Type DEVICE

Alloreactive NK cells will be purified by a two-step immunomagnetic selection (CD3 depletion followed by CD56 selection) using the CliniMACS device.

Interventions

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CliniMACS CD34 Reagent System

Alloreactive NK cells will be purified by a two-step immunomagnetic selection (CD3 depletion followed by CD56 selection) using the CliniMACS device.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients must have histologically documented AML, ALL, MDS, CML,
* Identification of haploidentical donor
* LVEF \> 45% corrected
* DLCO \> 50% predicted
* Serum Creatinine \<= 2 mg/dL
* Bilirubin \< 2 x ULN
* AST, ALT \< 2 x ULN
* Age ≤ 65 years
* Performance Status 0-1

Exclusion Criteria

* Patients relapsing \<6 months after autologous SCT are not eligible.
* Patients with active infections requiring oral or intravenous antibiotics are not eligible for enrollment until resolution of infection
* No HIV disease
* Non-pregnant and non-nursing
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indiana University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sherif Farag, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

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Indiana University Cancer Center

Indianapolis, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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0612-26/ IUCRO-0179

Identifier Type: -

Identifier Source: org_study_id

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