LeukemiaPhase 3NCT00968838
A Study for Leukemia Patients With Life-Threatening Infections
A Phase 3 study testing White Blood Cell Transfusion in people with Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- White Blood Cell Transfusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Aug 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of hematologic malignancy admitted to the Leukemia service.
- Severe neutropenia defined as Absolute neutrophil count (ANC) less than or equal to 1000.
- Persistent fever and/or signs of life threatening infection despite 48 hours on antibiotics.
- Sign a written informed consent form.
- Greater than 18 years of age.
Who cannot join
- 1) None
Trial locations and contacts
1 site in 1 country.
About this 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
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.
Read the 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.
- Conditions
- Leukemia
- Being tested
- White Blood Cell Transfusion
- Keywords
- White Blood Cell Transfusion, Radiated Cells, Unradiated Cells, Leukocyte Transfusions, Life-threatening Infections
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
White Blood Cell TransfusionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Non-radiated White Blood Cell Transfusion | Experimental | 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. Receives: Procedure: White Blood Cell Transfusion |
| White Blood Cell Transfusion | Experimental | 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. Receives: Procedure: White Blood Cell Transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Alive at Day 30
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).
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2009 (estimated)
- Study startApr 2009
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emil J Freireich, MD, BS, Study chair, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00968838
- Sponsor's protocol ID
- 2007-0797
- Status last verified
- Nov 2013
- First submitted
- 27 Aug 2009
- Last updated
- 26 Nov 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00968838
- Acronym / sponsor ID
- 2007-0797
- Conditions
- Leukemia
- Keywords
- White Blood Cell Transfusion, Radiated Cells, Unradiated Cells, Leukocyte Transfusions, Life-threatening Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 31 Aug 2009 (estimated)
- Results
- Posted 26 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-radiated White Blood Cell Transfusion | Experimental | Procedure: White Blood Cell TransfusionFour (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. |
| White Blood Cell Transfusion | Experimental | Procedure: White Blood Cell TransfusionFour (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of hematologic malignancy admitted to the Leukemia service.
- Severe neutropenia defined as Absolute neutrophil count (ANC) less than or equal to 1000.
- Persistent fever and/or signs of life threatening infection despite 48 hours on antibiotics.
- Sign a written informed consent form.
- Greater than 18 years of age.
Key exclusion criteria (1 listed)
- 1) None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| White Blood Cell Transfusion4 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. | Procedure or surgery | Non-radiated White Blood Cell Transfusion, White Blood Cell Transfusion |
Primary outcome
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emil J Freireich, MD, BS study chair
UT MD Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing White Blood Cell Transfusion in people with Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Alive at Day 30 (time frame: 30 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2013.