A Prospective Randomized Comparative Study of the Effect on Infections of Unirradiated Prophylactic White Cell Transfusions Versus Therapeutic Unirradiated White Cell Transfusions
White Blood Cell Transfusion
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.
Disease Group: Leukemia
Treatment Agent: White Blood Cell Transfusion
Treatment Location: Only at MD Anderson
Primary Objective: To determine if standard of care prophylactic antibiotics plus prophylactic white cell transfusions decrease the rate of infection compared to prophylactic antibiotics alone. Secondary Objectives: To compare prophylactic and therapeutic use of white cell transfusions in regards to: a) Median number of febrile days and use of IV antibiotics b) Infection related MICU-admissions c) Length of hospitalization d) Leukemia response and e) Overall survival.
IRB Review and Approval Date: 09/15/2010
Recruitment Status: Not Accepting
Projected Accrual: N/A
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
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.
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