Prophylactic White Cell Transfusions Versus Therapeutic White Cell Transfusions in Patients With Leukemia
Prophylactic White Cell Transfusions Versus Therapeutic White Cell Transfusions in Patients With Leukemia
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 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.
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