|
|
View Clinical Trial (Medical Research Study)
|
A Study for Leukemia Patients With Life-Threatening Infections - NCT00968838-77030 (Clinical Trial 307382)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy307382.aspx
|
** Please review additional "Nearby Studies" on right ----->
|
|
 |
 |
|
| City: |
|
Houston |
|
State:
|
|
TX |
| Zip Code: |
|
77030 |
| Conditions: |
|
Leukemia |
| 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.
|
| Study summary: |
|
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 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.
After 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 M. D. Anderson. |
| 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 |
|
|
|
| Study is available at: |
|
UT MD Anderson Cancer Center
Houston, TX 77030
United States
Primary Contact:
Emil J. Freireich, MD, BS
Phone: 713-792-2660 |
|
|
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
|
| Trials Alerts: |
|
If you would like to be
notified of new clinical trials as they become available please
register for a free account.
|
|
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
November 17, 2009 |
Modifications to
this listing: |
|
Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
|
|
|
|
|
|
|
|