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Study Summary
No. 2007-0797:.......Leukemia......Emil J Freireich......Leukemia
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Study Summary Title
Study Summary
Number:		2007-0797
Study Title:A Prospective Randomized Comparative Study of Radiated and Unradiated Leukocyte Transfusions for Patients with Life-threatening Infections: A Collaborative Study by the Leukemia Department and Laboratory Medicine
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Physician New Patient Referral
Name:Emil J FreireichPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:LeukemiaReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-2660
Contact us about clinical trials
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General Information
Disease Group:LeukemiaSupported By:N/A
Phase of Study:Phase IIIReturn
Visit:		None
Treatment
Agents:		White Blood Cell TransfusionHome Care:None
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		Not affected.
Description/
Intervention:		The goal of this clinical research study is to compare the effectiveness of a
white blood cell transfusion with radiated cells to a white blood cell
transfusion with cells that have not been radiated. The safety of this
procedure will also be studied.
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Study Objectives / Outcomes
To improve control of life-threatening infections in leukemia patients by the study of unradiated white blood cell transfusion using a prospective randomized comparative study, comparing unradiated white blood cells to radiated white blood cell infusion.

The primary objective will be to decrease the 30-day mortality by 25% for unradiated leukocytes when compared to the radiated leukocyte controls.

A secondary objective will be to evaluate the long-term progression-free survival of the two treatments, radiated and unradiated white cells in order to observe the impact of the reduction of acute mortality on long-term survival and to detect any potential late events such as transfusion associated graft versus host disease.
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Study Status Information
Study Activation / Registration Date:07/16/2008
IRB Review and Approval Date:05/06/2008
Study Type:Phase Iii
Recruitment Status:Open
Projected Accrual:N/A
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:1) Diagnosis of hematologic malignancy admitted to the Leukemia service.

2) Severe neutropenia defined as ANC less than or equal to 1000.

3) Persistent fever and/or signs of refractory life threatening infection not responding to anti-infective for at least 96 hours.

4) Sign a written informed consent form.

5) Greater than 18 years of age.
Exclusion Criteria:1) None
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Links
Registration Number: NCT00968838
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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