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Cytokine Induced Killer Cells as Post-Transplant Immunotherapy Following Allogeneic Hematopoietic Cell Transplantation

NCT ID: NCT00185757

Last Updated: 2012-12-17

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

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2012-12-31

Brief Summary

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The purpose of the study is to determine if the use of activated T cells can effectively treat relapsed disease following allogeneic hematopoietic cell transplantation without causing GVHD.

Detailed Description

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Conditions

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Multiple Myeloma Blood and Marrow Transplant (BMT)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cytokine-induced Killer Cells

The first cohort =1X10 7 cf expanded cells/kg. The second cohort = 5x10 7 expanded cells/kg. The second cohort = 1X10 8 expanded cells/kg.

Group Type EXPERIMENTAL

Cytokine Induced Killer Cells

Intervention Type DRUG

CIK cell dose escalation will be performed in cohorts of three patients per group. The initial dose utilized will be 1x107 expanded cells/kg. Previously, unmanipulated donor lymphocytes administered at this dose did not result in significant GVHD 7. The expansion of the CIK cell population is expected to diminish the T cell subsets responsible for GVHD further reducing the risk of GVHD to recipients. The dose will be increased to 5x107 expanded cells/kg and 1x108 expanded cells/kg in successive escalations based on no significant infusional toxicity or GVHD in the recipients

Interventions

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Cytokine Induced Killer Cells

CIK cell dose escalation will be performed in cohorts of three patients per group. The initial dose utilized will be 1x107 expanded cells/kg. Previously, unmanipulated donor lymphocytes administered at this dose did not result in significant GVHD 7. The expansion of the CIK cell population is expected to diminish the T cell subsets responsible for GVHD further reducing the risk of GVHD to recipients. The dose will be increased to 5x107 expanded cells/kg and 1x108 expanded cells/kg in successive escalations based on no significant infusional toxicity or GVHD in the recipients

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* eligible for DLI
* no evidence of GVHD
* stable immunosuppressive regimen
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Robert Negrin

OTHER

Sponsor Role lead

Responsible Party

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Robert Negrin

Professor of Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Robert S Negrin

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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95070

Identifier Type: -

Identifier Source: secondary_id

BMT162

Identifier Type: -

Identifier Source: secondary_id

NCT00185757

Identifier Type: -

Identifier Source: secondary_id

13644

Identifier Type: OTHER

Identifier Source: secondary_id

BMT162

Identifier Type: -

Identifier Source: org_study_id