A Study for Leukemia Patients With Life-Threatening Infections

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00968838
First received: August 27, 2009
Last updated: November 1, 2013
Last verified: November 2013
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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:


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

Primary Outcome Measures:
  • Number of Participants Alive at Day 30 [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
    Participant survival measured over the 30 days subsequent to the first granulocyte transfusion. Collecting complete blood counts (CBCs) pre and post transfusion allows determination of whether the duration of neutrophil replacement differs between the two study groups (comparing unradiated white blood cells to radiated white blood cell infusion).


Enrollment: 178
Study Start Date: April 2009
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Non-radiated White Blood Cell Transfusion
Four (4) non-radiated white blood cell transfusions. Each transfusion given daily and taking from 1 hour to several hours depending on toleration of the treatment.
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.

Experimental: White Blood Cell Transfusion
Four (4) standard white blood cell transfusions (with radiation). Each transfusion given daily and taking from 1 hour to several hours depending on toleration of the treatment.
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.


  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  1. Diagnosis of hematologic malignancy admitted to the Leukemia service.
  2. Severe neutropenia defined as Absolute neutrophil count (ANC) less than or equal to 1000.
  3. Persistent fever and/or signs of life threatening infection despite 48 hours on antibiotics.
  4. Sign a written informed consent form.
  5. Greater than 18 years of age.

Exclusion Criteria:

1) None

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
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:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00968838     History of Changes
Other Study ID Numbers: 2007-0797
Study First Received: August 27, 2009
Results First Received: June 6, 2013
Last Updated: November 1, 2013
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:
Infection
Leukemia
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 28, 2014