Leukemia
Conditions
Keywords
Acute myelogenous leukemia, AML, Undifferentiated and bi-phenotypic leukemia, High-risk myelodysplastic syndrome, Chronic myelogenous leukemia, Infection, Radiated Prophylactic White Cell Transfusions, Therapeutic Radiated White Cell Transfusion, prophylactic antibiotics
Brief summary
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.
Detailed description
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 in Group 1, you will receive the standard of care drugs that are used to prevent infections. You will also receive unirradiated white blood cell transfusions 2-3 times each week. If at any point you develop an infection, white blood cell transfusions will then be given daily in addition to the standard treatment for the infection. * If you are in Group 2, you will receive the standard of care drugs that are used to prevent infections. You will only receive unirradiated white blood cell transfusions if at any point you develop an infection. You will receive these transfusions daily, in addition to the standard treatment for the infection. 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.
Interventions
PROCEDUREProphylactic White Cell Transfusion
Radiated white blood cell transfusions 2-3 times each week, or daily if infection develops
PROCEDURETherapeutic White Cell Transfusion
Radiated white blood cell transfusions daily only with infection (or persistent fever)
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult and pediatric (=/\> 2 years old) patients with a diagnosis of acute myelogenous leukemia (including undifferentiated and bi-phenotypic leukemia), or high-risk myelodysplastic syndrome, or chronic myelogenous leukemia in blast crisis who will receive first or second anti-leukemia therapeutic intent with chemotherapy, targeted therapy or hypomethylating agents 2. Patients must sign an informed consent indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital.
Exclusion criteria
1. Patients with baseline (at start leukemia treatment) infection, defined as patients with a)fever and known positive cultures at the time of randomization; or b) chest or sinus computed tomography with findings suggestive of pneumonia or sinusitis; or c) one positive galactomannan test \>/= 1 or two positive galactomannan text \>/= 0.5 to 1 2. Patients with Zubrod performance status \>/= 3
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Infection | Blood draw 2-3 times a week while hospitalized, weekly thereafter. Participant to remain on study 42 days after transfusion. | Primary outcome is infection (yes/no) where participant without infection found by day 42 patient are counted as 'No' to infection. |
Countries
United States
Participant flow
Recruitment details
Recruitment Period: September 15, 2010 to January 2, 2013. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.
Pre-assignment details
One participant was not treated and is therefore excluded from the trial.
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 (Prophylactic Arm) Prophylactic Treatment (standard of care prophylactic antibiotics) + Prophylactic White Cell Transfusion. Radiated white blood cell transfusions 2-3 times each week, or daily if infection develops | 1 |
| Arm 2 (Therapeutic Arm) Prophylactic Treatment (standard of care prophylactic antibiotics) + Therapeutic White Cell Transfusion. Radiated white blood cell transfusions daily only with infection (or persistent fever) | 3 |
| Total | 4 |
Baseline characteristics
| Characteristic | Total | Arm 1 (Prophylactic Arm) | Arm 2 (Therapeutic Arm) |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 0 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 1 Participants | 1 Participants |
| Region of Enrollment United States | 4 participants | 1 participants | 3 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Male | 3 Participants | 0 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 1 | 0 / 3 |
| serious Total, serious adverse events | 0 / 1 | 0 / 3 |
Outcome results
Primary
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.
Population: Outcomes inevaluable due to low recruitment.