A Study for Leukemia Patients With Life-Threatening Infections

November 1, 2013 updated by: M.D. Anderson Cancer Center

Comparative Study of Radiated and Unradiated Leukocyte Transfusions for Patients With Life-threatening Infections: A Collaborative Study by the Leukemia Department and Laboratory Medicine

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Radiated White Blood Cell Transfusions:

White blood cell transfusions from a volunteer donor may contain blood cells that your body can react with to produce a disorder called transfusion-associated graft versus host disease. This means that some of the injected white blood cells can reproduce in your body and react with your own tissues and create side effects. To avoid this, the blood is radiated (changed through radiation) to kill all the cells that can divide. But this radiation also may destroy some of the infection-fighting capacity of the white blood cell transfusion, this may decrease the effectiveness of these white blood cell transfusions. Radiating white blood cells is the standard procedure that has been used to treat serious, life-threatening infections.

Non-Radiated White Blood Cell Transfusions:

If the white blood cells are not radiated, it may increase the effectiveness of these white cell transfusions. This may help the white blood cells to make more infection-fighting white blood cells. But, the cells that are also responsible for the transfusion-associated graft versus host disease will not be killed. This increases the risk that you could have this complication.

Study Groups:

If you agree to take part in this study, and if you are one of the first 40 patients, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. You or your physician will not know the results of this randomization. If you are in Group 1, you will have a non-radiated white blood cell transfusion. If you are in Group 2, you will have a standard white blood cell transfusion (with radiation). If you are less than 50 years old, you will receive 4 transfusions of radiated white cells. If you continue to show signs and symptoms of infection you will receive additional white cell transfusions based on the group you were randomized to.

If you are after the first 40 patients, you will be placed in a group that the study doctor thinks will most benefit you. It is important to note that this study is designed as a "adaptive randomization" which means that as the outcome for each individual is observed, the next patient receives the product which is most likely to be beneficial and least likely to be harmful.

White Blood Cell Transfusion:

Before the transfusion, a nurse will take your temperature, breathing rate and blood pressure. During the transfusion a nurse will watch you closely. Side effects sometimes occur during and soon after the transfusion. You may be given a drug to help or reduce any side effects.

If you are in Group 2, you will receive 4 standard white blood cell transfusions (with radiation).

If you still have an infection after 4 transfusions and the doctor thinks it is necessary, you will have additional transfusions. You will continue to have transfusions until the doctor feels the infection has been controlled. If you experience graft-versus-host disease (GVHD), this will be up to your doctor's discretion.

If you need a white blood cell transfusion for a new infection or for an infection that comes back, you will receive the same type of transfusion as you received before.

If you were discharged from the hospital and your doctor would like for you to continue receiving white blood cell transfusions, you will be able to receive them as an outpatient.

Each transfusion will take from 1 hour to several hours depending on how you tolerate the treatment. Each transfusion will be given daily or as close to daily as possible.

Before every infusion, blood (about 1 tablespoon) will be drawn to measure the number of white blood cells in your blood.

Length of Study:

You will receive transfusions until your doctor feels the infection has been controlled.

This is an investigational study. White blood cell transfusions are considered standard procedure for the treatment of serious, life threatening infections.

Up to 150 patients will take part in this study. All will be enrolled at The University of Texas (UT) MD Anderson Cancer Center.

Study Type

Interventional

Enrollment (Actual)

178

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • UT MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Alive at Day 30
Time Frame: 30 Days
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).
30 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Study Chair: Emil J Freireich, MD, BS, UT MD Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (ACTUAL)

August 1, 2011

Study Completion (ACTUAL)

August 1, 2011

Study Registration Dates

First Submitted

August 27, 2009

First Submitted That Met QC Criteria

August 28, 2009

First Posted (ESTIMATE)

August 31, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

November 26, 2013

Last Update Submitted That Met QC Criteria

November 1, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-0797

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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