UARK 2006-28 Human Cord Blood Transplantation in Advanced Hematological Malignancies

NCT ID: NCT00578045

Last Updated: 2015-10-26

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

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2011-03-31

Brief Summary

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The researchers want to find out if subjects treated on this study will achieve long term bone marrow recovery (engraftment) and if their tumors will respond to this treatment.

Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Approximately 24 hours after the chemotherapy is completed you will receive the transfusion of the human cord blood

Group Type EXPERIMENTAL

Transfusion

Intervention Type PROCEDURE

Approximately 24 hours after the chemotherapy is completed you will receive the transfusion of the human cord blood

Interventions

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Transfusion

Approximately 24 hours after the chemotherapy is completed you will receive the transfusion of the human cord blood

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with advanced hematological malignancies who have failed at least two lines of therapy.
* Karnofsky performance score \> 60, unless due to disease and then \> 50.
* Age \> 18 years.
* An expected survival of \> 3 months.
* Subjects must have signed an IRB-approved consent and been informed about the investigational nature of the study.
* Cord blood must have negative serology for HIV.
* Release of cord blood.
* The nucleated cell count of the CBU shall equal or exceed 1 x 107 per kg of recipient body weight.

Exclusion Criteria

* Liver function: total bilirubin \> 2x ULN or AST/ALT \> 3x ULN.
* Creatinine \> 3.0 mg/dL.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Arkansas

OTHER

Sponsor Role lead

Responsible Party

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University of Arkansas for Medical Sciences

Principal Investigators

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Frits van Rhee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

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University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Countries

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United States

Other Identifiers

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67363

Identifier Type: -

Identifier Source: org_study_id

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