A Study for Leukemia Patients With Life-Threatening Infections - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00968838

Purpose

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.

Condition	Intervention	Phase
Leukemia	Procedure: White Blood Cell Transfusion	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Single Group Assignment, Safety/Efficacy Study
Official Title:	Comparative Study of Radiated and Unradiated Leukocyte Transfusions for Patients With Life-threatening Infections: A Collaborative Study by the Leukemia Department and Laboratory Medicine

Resource links provided by NLM:

MedlinePlus related topics: Blood Transfusion and Donation Cancer Leukemia, Adult Acute Leukemia, Adult Chronic

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

30-Day Mortality Rate [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	150
Study Start Date:	April 2009
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Non-radiated White Blood Cell Transfusion: Experimental	Procedure: White Blood Cell Transfusion 4 Transfusions, each taking approximately 1 hour: Patients <50 years of age receive 4 standard transfusions before they are randomized to receive further radiated or non radiated transfusions. Patients >50 years of age are randomized to receive either radiated or non radiated transfusions.
White Blood Cell Transfusion: Experimental Standard white blood cell transfusion (with radiation)	Procedure: White Blood Cell Transfusion 4 Transfusions, each taking approximately 1 hour: Patients <50 years of age receive 4 standard transfusions before they are randomized to receive further radiated or non radiated transfusions. Patients >50 years of age are randomized to receive either radiated or non radiated transfusions.

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of hematologic malignancy admitted to the Leukemia service.
Severe neutropenia defined as ANC less than or equal to 1000.
Persistent fever and/or signs of refractory life threatening infection not responding to anti-infective for at least 96 hours.
Sign a written informed consent form.
Greater than 18 years of age.

Exclusion Criteria:

None

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00968838

Contacts

Contact: Emil J. Freireich, MD, BS

713-792-2660

Locations

United States, Texas
UT MD Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Emil J Freireich, MD, BS

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Study Chair:

Emil J Freireich, MD, BS

UT MD Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	UT MD Anderson Cancer Center ( Emil J Freireich, MD, BS / Professor )
Study ID Numbers:	2007-0797
Study First Received:	August 27, 2009
Last Updated:	November 30, 2009
ClinicalTrials.gov Identifier:	NCT00968838 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

White Blood Cell Transfusion
Radiated Cells
Unradiated Cells
Leukocyte Transfusions
Life-threatening Infections

Additional relevant MeSH terms:

Leukemia
Neoplasms
Neoplasms by Histologic Type
Infection

ClinicalTrials.gov processed this record on February 08, 2010