A Phase 2 interventional study of Prophylactic White Cell Transfusion and Therapeutic White Cell Transfusion in Leukemia, sponsored by M.D. Anderson Cancer Center. Terminated at 1 site in United States. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2015-06-10.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Prevention
Patients with leukemia often have low white blood cell counts after chemotherapy, which puts them at greater risk for infection. The standard of care for preventing infections is to give these patients antibiotic, antifungal, and antiviral drugs during the time that white blood cell counts are low. However, many patients still develop infections during chemotherapy. Radiated white blood cell transfusions are a standard treatment once a patient develops a severe infection.
The goal of this clinical research study is to learn if giving unirradiated white blood cell transfusions early in chemotherapy might delay or prevent infections in patients with leukemia. Researchers also want to learn more about the type and severity of any infections that do occur.
Study Groups:
If you are found to be eligible to take part of this study, and you are 1 of the first 60 participants to be enrolled, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups:
If you are not 1 of the first 60 participants to be enrolled, you will be assigned to the study group that the study doctor decides is in your best interest. This will be decided based on how the first participants have responded to the different treatments.
The drugs you receive as part of the standard therapy will be up the study doctor.
Study Procedures:
During each white blood cell transfusion, you will receive white blood cells from a volunteer donor through a needle in your vein. Each transfusion will take anywhere from 1 hour to several hours, depending on how you tolerate the treatment.
Before each white blood cell transfusion, your vital signs will be recorded. During and for 1 hour after the transfusion, you will be monitored for side effects. You may be given a drug to help or reduce any side effects. Your doctor will tell you more about any drug that is given for side effects.
While you are in the hospital for leukemia treatment, blood (about 1 teaspoon) will be drawn to check for fungal infections 2-3 times each week. This test will be done 1 time each week when you are not in the hospital until the doctor no longer thinks it is needed.
If at any point you develop a fever while on study, blood (about 1 teaspoon) will be drawn to check for infection. You will also have a CT scan within 3 days of developing a fever. If the doctor thinks it is needed, you will then have a CT scan 2 weeks later and at any other point that the doctor thinks it is needed to check for infection.
Length of Study:
You will continue to have transfusions until the doctor thinks infection has been controlled or until your white blood cell counts stay at a certain level for at least 2 days in a row. If at any point you are discharged from the hospital and your doctor wants you to continue receiving white blood cell transfusions, you will be able to receive them as an outpatient.
You will be monitored for side effects and signs of infection for up to 2 cycles of anti-leukemia treatment through a review of your medical record. You will be taken off study if you have intolerable side effects.
This is an investigational study. Radiated white blood cell transfusions are considered to be a standard procedure for the treatment of serious infections. It is investigational to give unirradiated white blood cell transfusions as a way of preventing infections.
Up to 240 patients will take part in this study. All will be enrolled at MD Anderson.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 5 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Prophylactic Treatment (standard of care prophylactic antibiotics) + Prophylactic White Cell Transfusion
Procedure: Prophylactic White Cell Transfusion
Prophylactic Treatment (standard of care prophylactic antibiotics) + Therapeutic White Cell Transfusion
Procedure: Therapeutic White Cell Transfusion
Radiated white blood cell transfusions 2-3 times each week, or daily if infection develops
Radiated white blood cell transfusions daily only with infection (or persistent fever)
Number of Participants With Infection
Primary outcome is infection (yes/no) where participant without infection found by day 42 patient are counted as 'No' to infection.
Time frame: Blood draw 2-3 times a week while hospitalized, weekly thereafter. Participant to remain on study 42 days after transfusion.
Recruitment Period: September 15, 2010 to January 2, 2013. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.
| Milestone | Arm 1 (Prophylactic Arm) | Arm 2 (Therapeutic Arm) |
|---|---|---|
| Started | 1 | 3 |
| Completed | 0 | 0 |
| Not completed | 1 | 3 |
Primary outcome is infection (yes/no) where participant without infection found by day 42 patient are counted as 'No' to infection.
No measurements were reported for this outcome.
Collected over Adverse events collected for up to two cycles of anti-leukemia treatment. Overall study period: June 16, 2011 to August 30, 2012.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm 1 (Prophylactic Arm) | — | 0/1 (0%) | 0/1 (0%) |
| Arm 2 (Therapeutic Arm) | — | 0/3 (0%) | 0/3 (0%) |
| Age, Categorical(Participants) | Arm 1 (Prophylactic Arm) | Arm 2 (Therapeutic Arm) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 1 | 1 | 2 |
| >=65 years | 0 | 2 | 2 |
| Sex: Female, Male(Participants) | Arm 1 (Prophylactic Arm) | Arm 2 (Therapeutic Arm) | Total |
|---|---|---|---|
| Female | 1 | 0 | 1 |
| Male | 0 | 3 | 3 |
| Region of Enrollment(participants) | Arm 1 (Prophylactic Arm) | Arm 2 (Therapeutic Arm) | Total |
|---|---|---|---|
| United States | 1 | 3 | 4 |
This study is terminated, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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M.D. Anderson Cancer Center